講演者

Silvia Acosta-Gutierrez is a computational biophysicist and Beatriu de Pinos fellow in the Institute for Bioengineering of Catalonia and the Computational Lead of the Molecular Bionics Lab. Born in the Canary Islands, she earned her PhD in 2017 as part of the MSCA Initial Training Network Translocation, where she specialised in classical physics-based computational methods and enhanced sampling methods for predicting antibiotics permeability. During her first postdoc at the Chemistry Department of UCL in the group of Prof. Francesco L. Gervasio, she initiated studies of allostery in central nervous system drug targets, focusing on the selective activation of G-protein coupled receptors and drug development. In 2020, she joined the Molecular Bionics Lab at the Chemistry Department of UCL to develop an intelligent platform for designing phenotypic medicines. She was awarded the Beatriu de Pinos postdoctoral fellowship in 2021 to continue this work at the Institute for Bioengineering of Catalonia. As Computational Lead of the Molecular Bionics Lab, she works both on the phenotypic medicines design and aids the 3D reconstruction of proteins imaged via in situ transmission electron microscopy. Her interests focus on leveraging computational biology/biophysics and artificial intelligence to understand complex biological systems at the level of actionable drug design.

• Formulation and Stability

I am an Analytical Development Scientist at ElevateBio with over 6 years of combined experience in academics and industry. I design and develop cell-based assays that are fit-for-purpose in process development and quality control. My experience is mostly in the cell therapy space, and I am very passionate about delivering the therapies of the highest quality.

• Cell Therapy CMC and Analytics

Raquel Aires-Barros is a Full Professor in the Department of Bioengineering (DBE) at Instituto Superior Tecnico (IST), Universidade de Lisboa, and researcher at the Institute of Bioengineering and Biosciences (IBB). Chair of the Section Downstream Processing of the European Society of Biochemical Engineering Sciences (ESBES); Vice-President of the Portuguese Society for Biotechnology and editor of Separation and Purification Technology Journal. Current research interests include the development of new separation processes with high performance and efficiency for purification biopharmaceuticals and the development of devices- "Lab-on-a-Chip" - for biomolecules purification.

• Advances in Recovery and Purification

Arun Alphonse Ignatius is a Director of Drug Product Sciences at Macrogenics. His team is responsible for CMC aspects of drug product development for early and late stage oncology portfolio at Macrogenics. In his tenure at Pfizer, he contributed as a group lead and as a function lead for multiple products (ABRILADA™, 20vPNG, mAbs, GTx-gene therapies). He was involved in advancing GTx portfolio and building platform formulation and process development capabilities. He served as a Pfizer Worldwide R&D postdoctoral program committee member and as postdoc mentor. His research focuses on the biophysical characterization of wide range biotherapeutics (AAV, mAbs, Fc Fusion, vaccines, DNA, RNA) including higher order structure characterization using NMR. He has over 30 peer-reviewed publications in the area of protein formulation, biophysical characterization and structural biology.

• Formulation and Stability

Peter Andorfer is a scientist at the Gene Therapy Process Development department within Takeda in Orth in Austria. His responsibilities include the development and implementation of analytical techniques targeting AAV functionality, genome integrity or the evaluation of full/truncated/empty species. His expertise ranges from in vitro biopotency to analytical methods like CE, dPCR or Flow Cytometry. Peter holds a Master's degree in Genetics and Bioinformatics and a PhD in Molecular Biology.

• Gene Therapy CMC and Analytics

Ricardo Baptista has been working in Manufacturing Development and CMC of Cell & Gene Therapies. Ricardo currently holds the role of Director Process & Analytical Development of Cellectis SA France, Lead Scientist at The Cell and Gene Therapy Catapult UK, and at the Centre for Commercialisation of Regenerative Medicine-CCRM, Canada. He directed and managed teams designing and developing bioprocessing and analytical platforms for the scalable manufacture of allogeneic cell and gene therapies. Ricardo was also involved in the generation and manufacture of clinical-grade ESC and iPSC lines, and design and construction of GMP facilities. Ricardo is a Biotechnology Engineer, obtained his PhD degree in Biotechnology and Biochemical Engineering at Instituto Superior Tecnico, Portugal, and at Peter Zandstra's Stem Cell Bioengineering Lab, in Canada.

• Cell Therapy CMC and Analytics

Iris L. Batalha is currently a Junior Leader Research Fellow at the Institute of Bioengineering of Catalonia (IBEC) in Barcelona, a Panel Tutor in Nanotherapeutics at the University of Cambridge Institute of Continuing Education, a freelance Senior Innovation Consultant at Inspiralia (Spain and USA), a Co-Founder, Director and Editor-in-Chief of the non-profit organisation Women Ahead of Their Time (WATT), and a Research Associate at Peterhouse College. From 2017 to 2020, she was a joint Research Associate at the Department of Engineering Nanoscience Centre and Department of Medicine Molecular Immunity Unit, University of Cambridge. From 2014 to 2017, she worked at the Department of Chemical Engineering and Biotechnology, University of Cambridge, and the biopharmaceutical company MedImmune/AstraZeneca, followed by a brief experience as a healthcare/pharmaceutical consultant. Her research interests and expertise lie in medical and pharmaceutical research and development, particularly in the fields of nanobiotechnology, bio-inspired materials, downstream processing, formulation, and drug delivery.

• Formulation and Stability

Dr. Richard D. Braatz is the Edwin R. Gilliland Professor at the Massachusetts Institute of Technology (MIT). He leads the modeling, control, and systems activities in many biopharmaceutical manufacturing efforts at MIT, including for vaccines, gene therapy, and monoclonal antibodies. Most activities are in automated process development workflows and modeling, design, and control of fully automated modular manufacturing unit operations and end-to-end systems, which are experimentally validated. He has consulted or collaborated with more than 25 companies including Novartis, Pfizer, Merck, Biogen, Sanofi, and Amgen. Honors include the AIChE PD2M Award for Outstanding Contribution to QbD for Drug Substance, the AIChE Separation Division Innovation Award, the AIChE Excellence in Process Development Research Award, the Research Collaboration Award from the Council for Chemical Research, and the IEEE Control Systems Society Transition to Practice Award. He is a member of the National Academy of Engineering.

• Intensified and Continuous Processing

Daniel G. Bracewell is Professor of Bioprocess Analysis at the UCL Department of Biochemical Engineering. He has made major contributions to the fundamental understanding of biopharmaceutical purification operations, including collaborations with Thailand, India and the USA. He has authored more than 100 peer reviewed journal articles in the area to date and currently supervises 15 doctoral and postdoctoral projects, many of these studies are in collaboration with industry. One such project was the basis from which the spinout Puridify a nanofibre absorption technology company was created. He is academic lead for the UCL-Pall Biotech Centre of Excellence.

• Cell Line Development

Dr. Christoph Brandenbusch studied Chemical Engineering at the Department of Biochemical and Chemical Engineering at TU Dortmund, (Germany) 2003-2007. He finished his Ph.D. thesis in the field of downstream processing in biocatalysis in 2011. Since 2012 he works as a group leader and assistant professor at the Laboratory of Thermodynamics, Department of Biochemical and Chemical Engineering, TU Dortmund (Germany). His main research fields include: Novel strategies for protein purifications in pharmaceutical bio-processes as well as the development of liquid and lyophilized biopharmaceutical formulations. The methods used include analytical techniques as well as coarse-grained modeling approaches for predictive formulation screening.

• Formulation and Stability

Christopher founded Consulting on Advanced Biologicals Ltd at the end of 2009 in order to focus his activities within the Regenerative Medicine sector. Advbiols Ltd provides EU regulatory services to the regenerative medicine industry in addition to business and regulatory research and analysis to identify and focus on the real barriers to commercialisation of regenerative medicine. Christopher has a PhD in xenotranplantation immunology and spent 8 years in biotech (Imutran Ltd, A Novartis Pharma AG Co. and Intercytex) before joining the MHRA as a quality (CMC) assessor (biologicals and biotechnology unit). During this time Christopher was involved with National implementation of the new Advanced Therapies Regulation and also involved through his participation in the CHMP's cell products working party (CPWP) in implementation at the EMA level including drafting guidelines.

• Cell Therapy CMC and Analytics
• Gene Therapy CMC and Analytics

No bio available.

• Cell Therapy CMC and Analytics

Dr. Brinkman's research is focused on developing and applying flow cytometry bioinformatics approaches to advance our understanding of human health and disease. Early work centered on creating the data standards and a free, opensource computational infrastructure to support high-throughput computational statistical analysis of flow data as chair of ISAC's Data Standards Task Force, leading the development of recent versions of the FCS standard and FlowRepository. Recent efforts have concentrated around developing complete analysis pipelines that cover all the steps from flow cytometry data pre-processing to clinical diagnosis and biomarker discovery across all the areas where the technology is applied. Dr. Brinkman has widely applied these methodologies to both the diagnosis of patients and discovery of biomarkers in basic research and clinical investigations including through the company he founded and led (Cytapex Bioinformatics, Inc.) until its acquisition by Insightful Science. Dr. Brinkman has been recognized for these efforts as a Michael Smith Foundation for Health Research Scholar, a Terry Fox Foundation New Investigator, and an ISAC Scholar.

• Cell Therapy CMC and Analytics

Awarded a PhD in Biochemistry from the University of Kent in 2015. Is a named inventor on 3 internationally recognised patents in the mammalian bioprocessing field. Worked with the National Biopharmaceutical Facility (NBF) in Thailand to help build capacity and infrastructure for antibody production from mammalian cells. Currently works in a collaboration with Lonza Biologics as one of their pioneering "Centre of Excellence" initiatives.

• Cell Line Development

Michael Butler is a Principal Investigator in Cell Technology at the National Institute of Bioprocessing Research & Training (NIBRT), Ireland, Adjunct Full Professor in University College Dublin as well as Distinguished Professor Emeritus of the University of Manitoba, Canada. He holds degrees in Chemistry and Biochemistry from the Universities of Birmingham, London (UK) and Waterloo (Canada). He was the scientific director of MabNet, a Canadian network for Mab production and founder of Biogro Technologies Inc., a spin-off company dedicated to serum-free media development. His research work focuses on the development of bioprocesses using mammalian cells for the production of recombinant proteins, monoclonal antibodies and viral vaccines.

• Cell Culture and Bioproduction

Giovanni Campolongo (eMBA) - Senior Market Segment Manager Biopharma

Business development professional with experience in Biopharma, Chemical and Food Industry. Currently working for the Business Unit Process Analytics by Hamilton Bonaduz AG as Segment Manager dedicated to the development of product and services portfolio for biopharma PAT applications: upstream and downstream. This includes active partnership with private industry as well as public organizations.

• Cell Culture and Bioproduction

Vered Caplan CEO Orgenesis Inc, a global biotech company working to unlock the full potential of cell and gene therapies in an affordable and accessible format at the point of care. Orgenesis identifies promising new therapies and leverages its POCareTM Platform to provide a rapid, globally harmonized pathway for these therapies to reach and treat large numbers of patients at lowered costs through efficient, scalable, and decentralized production. Prior to Orgenesis, Vered has been CEO of Kamedis, a company focused on utilizing plant extracts for dermatology purposes. From 2004 to 2007, Ms. Caplan was CEO of GammaCan, a company focused on the use of immunoglobulins for the treatment of cancer. During the previous five years, Ms. Caplan has been a director of numerous companies in the biotech industry, among them: Inmotion Ltd., a company involved with self-propelled disposable colonoscopies; Nehora Photonics Ltd., a company involved with non-invasive blood monitoring and others. Ms. Caplan has a M.Sc. in biomedical engineering from Tel Aviv University specializing in signal processing; management for engineers from Tel Aviv University specializing in business development; and a B.Sc. in mechanical engineering from the Technion-Israel Institute of Technology specialized in software and cad systems.

• Cell Therapy Manufacturing

Christine Carapito earned a PhD in Analytical Chemistry from the University of Strasbourg focusing on the development of mass spectrometry-based proteomics and proteogenomics methods in 2006. She then joined the laboratory of Professor Ruedi Aebersold at the Institute of Molecular Systems Biology at ETH Zurich as a postdoctoral fellow. There, she developed MS detection methods for the characterization of post-translational modifications and participated in the human SRM Atlas project. Today, she is a Research Director at the French National Center for Scientific Research (CNRS) and the University of Strasbourg. She leads developments in functional and computational proteomics at the BioOrganic Mass Spectrometry laboratory that she co-heads with Dr. Sarah Cianferani. She supervised ten PhD theses, is involved in teaching mass spectrometry and proteomics at the University of Strasbourg, and holds editorial engagements. She has co-authored over 90 peer-reviewed articles. In 2018, she received the CNRS Bronze Medal and the award "Les Espoirs de l'Universite de Strasbourg." She has been elected President of the French Proteomics Society from 2017 to 2020 and a member of the European Proteomics Association Executive Committee in charge of Education since December 2020.

• Analytics and Characterisation

Marco Cardinali got a Ph.D in Physics and joined GSK Vaccines as an AI/ML Engineer in Technical R&D. Marco is currently working on Machine Learning application in upstream processes, with special focus in mammalian cell cultures.

• Cell Culture and Bioproduction

Veronique Chotteau, Associate Professor, Principal Investigator of the Cell Technology group, Dept. Industrial Biotechnology, School of Engineering Sciences in Chemistry, Biotechnology, and Health, KTH (Royal Institute of Technology), Stockholm, Sweden; Education: BSc Eng. Sciences, MSc Electrical Engineering, MSc Biotechnology, PhD Automatic Control/Modelling/Biotechnology (University of Louvain, Belgium); V. Chotteau has 30 years of experience in mammalian cell culture including more than 10 years in biopharmaceutical industry (at Pharmacia Upjohn/Biovitrum, Stockholm, nowadays Swedish Orphan Biovitrum). She is the Director of AdBIOPRO, Centre for Advanced Bioproduction by Continuous Processing, and Coordinator of iConsensus, EU IMI2 project. She joined KTH in 2008, when she was offered to lead the animal cell cultivation activities. Her group is focusing on cell-based processes for biologics production, high cell density perfusion of CHO and HEK293 cells, mathematical modelling, and production of viral vectors. Her group was the first to publish cell densities higher than 200 millions cells/mL in CHO cell perfusion process.

• Intensified and Continuous Processing

Jessica has a Master of Science in Biotechnology from the University of applied Science in Frankfurt.  2015 she started her career as a Lab Engineer in DSP at Sanofi. Now, Jessica works as a DSP lab head in Bioprocess Engineering and is responsible for the DSP technical pilot plant, technical transfers of processes from development to clinical manufacturing and evaluation of disposables.

• Advances in Recovery and Purification

John Churchwell completed his PhD in physical chemistry at Durham University in the UK, focussing on the spectroscopy of interfaces. He went on to a postdoctoral position at University College London, applying spatially offset Raman spectroscopy (SORS) for the diagnosis of bone disease both in vivo and ex vivo. During this time he received an EPSRC secondment to work with collaborators at the Central Laser Facility, part of the STFC Rutherford Appleton Laboratory, to develop novel chemometric methods. He maintains an honorary position at UCL and is a member of the editorial advisory board for the Journal of Raman Spectroscopy. In his current role as Associate Lead Scientist at the Cell and Gene Therapy Catapult he leads on the application of process analytical technology, chemometrics and advanced process control for the industrialisation of advanced therapies and the implementation of industry 4.0. John has extensive experience in the application of new analytical devices for monitoring and control of ATMP processes.

• Cell Therapy Manufacturing

Colin Clarke holds a MSc and PhD in Bioinformatics from Cranfield University, UK. He leads the Bioinformatics and Data Analytics Laboratory at the National Institute of Bioprocessing Research and Training, Dublin, Ireland and is an Associate Professor in the School of Chemical and Bioprocess Engineering at University College Dublin. The goal of Colin's systems biology research is to enhance our understanding of CHO cell factories to enable more efficient production. Colin's team also have an active research programme focussed on harnessing big data technologies for biopharmaceutical manufacturing. He was awarded the Martin Sinacore Outstanding Young Investigator Award at Cell Culture Engineering in 2014 and selected as the Young Leader of the Year at the 2017 Irish Laboratory Awards.

• Cell Line Development

Dr. Ana Sofia Coroadinha has a Degree in Biochemistry (University of Lisbon) and a PhD in Gene Therapy performed at Genethon, Helmholtz Centre for Infection Research (HZI) and iBET, granted in 2005 by ITQB-UNL. Since July 2009 is the Head of Cell Line Development and Molecular Biotechnology Lab at iBET and ITQB-NOVA. She has over 20 years of experience in recombinant viruses and animal cell culture, areas where she has published over 50 peer reviewed papers. Dr. Ana Sofia Coroadinha group research focus on applied virology developing recombinant virus and molecular tools supporting the areas of gene therapy, vaccine development and virology.

• Gene Therapy CMC and Analytics

No bio available.

• Cell Culture and Bioproduction

Hugo's home-country is Mexico, where he did his BSc in Biotechnology Engineering at the National Polytechnic Institute, with a thesis on characterization of cyanobacteria growing in bioreactor. After finalizing his studies, he worked for a year at the local biopharmaceutical Probiomed as technician in analytical development. Then he pursued a MSc in Life Sciences and Technology and PhD in the group of Cell Systems Engineering at Delft University of Technology focusing on metabolomic engineering of yeast. After his studies, he started his career as Fermentation Scientists at INVISTA UK, working on development of gas fermentation and valorization of waste streams. Then moved on to a role in Janssen (Johnson & Johnson) as USP Development Scientists in the department of Bacterial Vaccines Development. Currently, he works at uniQure as USP Lead Scientist, relentlessly pursuing a next-generation AAV production process with insect cells, which has taken his scientific interests towards investigating scale-down models in high-throughput platforms, cell line development, process modeling and rational process intensification leveraging information obtained through PAT. His hobbies are videogaming, animals, playing guitar and acting.

• Gene Therapy Manufacturing

Prof Paul Dalby is Director of the EPSRC Centre for Doctoral Training in Emergent Macromolecular Therapies, Co-Director of the EPSRC-funded Future Targeted Healthcare Manufacturing Hub, and Deputy Head of the Department of Biochemical Engineering at UCL. He also Chairs the Royal Society of Chemistry Biotechnology Interest Group. His research focuses on routes to improve therapeutic proteins for ease of manufacture, formulation and delivery to patients. His work combines protein engineering and formulation, with biophysical characterisation, molecular modeling and simulation, to understand the factors that influence protein stability, and to guide protein engineering for improved properties.

• Formulation and Stability

I am working as a senior scientist in the Bioprocess Development Department within CSL Behring Bern, Switzerland. I joined the company ten years ago in 2012 and since then had the possibility to gain lots of experience in the development of novel and optimization of existing manufacturing processes for plasma derived therapeutic agents. Before joining CSL Behring I was working as a postdoc at the Institute of Tropical Medicine in Hamburg, Germany and the Institute for Cell Biology in Bern, characterizing certain key enzymes in tropical parasites in order to identify potential drug targets.

• Intensified and Continuous Processing

Sian Davies studied her masters degree in Biochemical Engineering at University College London. She joined MeiraGTx in 2020 as a Scientist II, working within the downstream process development team. Over the last two years she has designed and optimised purification processes for AAV2, AAV5 and AAV8, predominantly focusing on ion exchange chromatography, looking to exploit the charge difference between the full and empty capsids. Prior to this Sian worked at Ipsen Biopharm, purifying potent molecules within a containment facility. At Ipsen she mainly worked on optimising a downstream process and transferring it into a new manufacturing facility.

• Gene Therapy Manufacturing

Mike is a Lead Technical Scientist that joined Cell and Gene Therapy Catapult in 2013 and has over 10 years' experience within the cell and gene therapy sector. He is currently the Strategic Lead for the Viral Gene Delivery programme, responsible for managing developmental output of the group on core-funded, collaborative and commercial operations. Having completed an EngD in Biochemical Engineering and BioProcess Leadership at UCL in association with Onyvax Ltd and ReNeuron Group plc, Mike previously fulfilled a research engineer role at TAP Biosystems (now part of the Sartorius Stedim Biotech Group). Here he supported the development of automated micro-scale bioreactors and novel upstream systems for use within the biotech and cell therapy sectors.

• Cell Therapy Manufacturing

Felix Dieringer is currently a PhD student at Takeda and a member of the Bioprocess Engineering DocSchool at BOKU, Vienna. His PhD Thesis focuses on environmental sustainability of biologics and the improvement of Green Metrics. Felix has several years of industry experience in downstream process development for recombinant complex proteins. Felix holds a master's degree in Medical Biotechnology from BOKU (University of Natural Resources and Life Sciences).

• Intensified and Continuous Processing

Dr. Elena Dominguez Vega received her Ph.D. degree on analytical chemistry in 2011 at the University of Alcala (Spain). After joining the Biomolecular Analysis group at Utrecht University (The Netherlands) in 2012, she worked on the development of new electrophoretic methods for the analysis of biopharmaceuticals. In 2013 she continued as postdoctoral researcher at VU University where she focused on the study of protein heterogeneity, conformation and affinity. In May of 2017, Dr. Dominguez Vega joined the Center for Proteomic and Metabolomics at the LUMC as assistant professor were she continue her work on the characterization of glycoproteins of clinical and pharmaceutical interest. Furthermore she has expanded her research focus to the development of innovative analytical platforms for the analysis of gene therapy products. Over the years, Dr. Elena Dominguez Vega has closely collaborated with several pharmaceutical companies and has received multiple grants and awards in support to her research.

• Gene Therapy CMC and Analytics

Leading Novasign as CEO, Mark is passionate to improve bioprocesses for the production of biopharmaceuticals, enzymes and substitutes for animal-derived proteins. With his team, he is developing a hybrid modeling software for both up and downstream processes. This software utilizes artificial intelligence applied to process data and first principle models (hybrid models) to not only accelerate bioprocess optimization but also to reuse these models for model predictive control strategies. The company Novasign was founded in 2019 offering this unique software solution which is already in use by several TOP25 pharma companies to also accelerate their process development.

• Cell Culture and Bioproduction

Dr. Durocher obtained his Ph.D. in Biochemistry at the Universite de Montreal. He joined the NRC in 1995 to work on the production of membrane receptors and recombinant proteins for various industrial partners involved in drug discovery projects. He manages a section of 30 scientists and 4 Ph.D. students involved in protein expression and stable CHO cell line development for internal projects and external clients. His research activities focus on improving large-scale transient gene expression (LSTGE) platforms using HEK293 and CHO cells for r-protein production, and on developing and engineering stable CHO pool and clonal cell line platforms for r-protein manufacturing. Dr. Durocher is also an Assistant Professor at the Departement de biochimie et medecine moleculaire at the Universite de Montreal.

• Cell Culture and Bioproduction

Ulla Elofsson is Associate Professor (not employed) at KTH and working as senior scientist at RISE Research Institutes of Sweden. She received her PhD in 1996 in Biophyiscal technology at Lund University after studies on interfacial and solution behaviour of self-associating proteins. She has a long experience of applying surface chemistry in the sectors of food, pharmaceuticals and for oral care applications, both from previous academic research and the last 20 years at RISE (previously YKI, Institute for Surface Chemistry). Her competence areas are biomolecules in solution and at interfaces, surface modifications, formulation, encapsulation, controlled delivery and release. Elofsson is one of the PI's in the Research Centre NextBioForm - Centre for Formulation and development of next-generation biologics, with the aim to create better products for patients. Protein stability and mechanistic understanding of drivers for aggregation and degradation in liquid and solids forms using advanced methodologies is at the heart of the centre activities. Professor Elofsson has supervised several PhD students with research focus of proteins at interfaces, and has more than 40 publications in peer reviewed journals.

• Formulation and Stability

PhD from Pasteur Institute in Paris and Post Doc at Boston University working on NF-kappa B transcription factor. Joined Cellectis in 2000 right after the creation of the company. Developed functional high throughput screening methods in yeast for Meganuclease and TALEN engineering. Became CTO of the company. Led the Tools & Services subsidiary before turning to CAR-T process development when the company focused on clinical approaches.

• Cell Therapy Manufacturing

Michel received his MSc. in Biology/Chemistry in 1993 from the University of Utrecht and his PhD in 1999 from the Wageningen University and Research at the Laboratory of Biochemistry with background in structure/function relationships of proteins. Michel Eppink has more than 30 years of experience in Downstream Processing of large biomolecules (proteins, lipids, carbohydrates).From 2009 up to 2014 Michel Eppink was Associate Professor and since 2014 he is Special Professor at the Department of Bioprocess Engineering at Wageningen University and Research heading a group of PhD candidates in the research of biorefinery technologies such as new purification/analytical techniques for proteins/lipids/carbohydrates from different eukaryotic organisms (e.g. mammalian cell lines, macroalgae, microalgae, yeast). In the Netherlands Michel is a section member of the Downstream Processing section of the Dutch Biotechnology Association. Internationally he is chair of the Microalgae Bioengineering Section of the European Society of Biochemical Engineering Sciences (ESBES) and scientific committee member of the International Symposium of Proteins and Peptides Purifications (ISPPP).Scientifically, he is involved in more than 100 scientific papers (h-index of 31).Next to that he is Senior Director Downstream Processing at Byondis BV (Biopharmaceutical Company) heading a department of 30 highly skilled coworkers developing purification / formulation processes for biopharmaceutical proteins such as monoclonal antibodies and antibody drug conjugates. Web links: Byondis BVhttps://www.byondis.com/Wageningen University:https://www.wur.nl/en/Research-Results/Chair-groups/Agrotechnology-and-Food-Sciences/Bioprocess-Engineering.htm https://www.wur.nl/en/Research-Results/Chair-groups/Agrotechnology-and-Food-Sciences/Bioprocess-Engineering/Research-themes/Biorefinery.htmProfile:https://www.linkedin.com/in/michel-eppink-b756834/https://www.researchgate.net/profile/Michel_Eppink https://www.narcis.nl/person/RecordID/PRS1323197/Language/enhttps://orcid.org/0000-0001-8297-9985NBV: https://nbv.kncv.nl/en/ESBES: https://esbes.org/ISPPP: https://www.isppp.net/

• Advances in Recovery and Purification

Precise, goal-oriented and creative biochemist with extensive experience in experimental design, execution, and data analysis, both in an academic as well as in an industry setting. Extensive knowledge in project management and team work. Enthusiastic about gaining knowledge in new fields. Passionate team player adept at providing leadership and enthusiasm to colleagues to achieve objectives. Ability to prioritize in a constantly changing work environment through strong organizational and planning skills.

• Advances in Recovery and Purification

Dr. Pierantonio Facco is an Associate Professor at the University of Padova, where he received his PhD in Chemical Engineering in 2009. His research interests are related to data analytics, machine learning, statistical and deep learning to support chemical and process engineering for: processes and product quality monitoring; product formulation and process development; process understanding; process, product and technology scale-up/down; statistical and model-based design of experiments. His main activities are concerned with multivariate statistical process and quality monitoring and control, Quality-by-Design, adaptive soft-sensing, process analytical technologies, and artificial vision systems. He is author of more than 100 publications, among which papers in peer reviewed journals, conference proceedings and book chapters.

• Cell Line Development

Paulo is currently an Associate Director leading the Vector Process Development team at Orchard therapeutics, a cell and gene therapy company dedicated to transforming the lives of people affected by rare diseases. Paulo did his PhD at NOVA University of Lisbon/iBET in Portugal, later joining another cell and gene therapy company - Autolus Therapeutics - in the UK. Paulo's career has been focused on cell line, analytical and bioprocess developments for viruses and viral vectors, and the respective transfer and manufacture to GMP. He is also an advocate for bioprocess applied to CGT products and an executive committee member of the European Society for Animal Cell Technology.

• Cell Therapy CMC and Analytics

Lara Fernandez Cerezo graduated from University College London with a Masters of Engineering in Biochemical Engineering in 2014. She then pursued an Engineering Doctoral degree, a 4-year industrial PhD program with Merck focusing on scale-down filtration technologies of high concentration mAbs. Upon graduation, she established the ambr® crossflow high throughput system as a process characterization/development UF/DF tool in the Merck process development teams. In 2019 she transitioned to continuous manufacturing (CM) in biologics gaining 'hands-on' experience in both non-GMP 50L development scale and GMP 500L clinical scale. Since moving back to the development group in the US in 2021, Lara continues to influence the GMP continuous manufacturing teams at Merck by providing recommendations for the design of our next-generation commercial CM facility including a customized SPTFF/ILDF Skid. Lara now leads the downstream biologics continuous manufacturing team in the Enabling Technology group at Merck. Other activities she is involved with include co-leading a Merck / Penn State Collaboration focusing on scale-up depth filtration challenges; and leading a IQ sub-group focusing on the use of UF/DF for post-conjugation steps in antibody-drug conjugates (ADCs).

• Intensified and Continuous Processing

Marcello Fidaleo is an associate professor at the University of Tuscia (Italy), where he teaches unit operations and design and analysis of experiments for the food and biotechnology industry. He is also a teaching fellow at the Biomanufacturing Training and Education Centre of North Carolina State University (Raleigh, USA) where he teaches a class on DoE for Bioprocess Characterization and Optimization. Marcello has about fifteen years of experience in design of experiments and data modeling in the field of membrane separation, enzymatic, microbial and chemical processes. He is the author of more than 50 scientific papers published on peer reviewed journals and has been a scientific consultant for companies operating in the fields of chemistry, biotechnology and food. Marcello holds a Master of Chemical Engineering from the Sapienza University of Rome and a Doctorate in Food Biotechnology from the University of Tuscia.

• TS2: Design of Experiments (DOE) for Bioprocess Analysis

Vito Fodera received his Ph.D. in Physics (2009) from the University of Palermo (Italy), with a project focused on (in)stability and self-assembly mechanisms of peptides and proteins. In 2009 he was appointed as a Research Associate at the Cavendish Laboratory at the University of Cambridge (UK). In 2012 Vito was awarded the Marie Curie IEF for Career Development grant that allowed him to join the Dept. of Drug Design and Pharmacology (University of Copenhagen). In 2016 he became tenured Associate Professor of Biophysics at the Department of Pharmacy, University of Copenhagen, where he established his research group. His main focus is on protein self-assembled structures and he aims at translating the fundamental knowledge on these systems into novel high-impact applications in advanced materials for nanomedicine, protein drug formulations and protein-related neurodegenerative diseases. In 2018 he is recipient of the Villum Young Investigator award and is the PI of the related 5-year initiative "ProSmart", focused on the understanding of structural heterogeneity in protein self-assembled materials via advanced microscopy approaches and X-ray and neutron techniques. Vito´s group works in close connection with both international collaborators in academia, large-scale facilities and national and international industrial entities. He is author of > 60 manuscripts.

• Formulation and Stability

Scientist and Bioengineer trained in biotechnology and biochemistry with a strong background in cell culture, protein production (bacteria, yeast, mammalian cells), drug delivery, and immunology. Working for Takeda in Austria as a development scientist. Dr.rer.nat-Free University Berlin MSc-Utrecht University BSc-University of Natural Resources and Life Sciences, Vienna (BOKU)

• Gene Therapy CMC and Analytics

Dr. Rajiv Gangurde is CTO at SparingVision, leading technical operation activities including process and analytical development, manufacturing, and quality assurance. Rajiv has over 16 years of industry experience in biopharmaceutical development, harnessed in the biotechnology hub of Massachusetts, USA. Before joining SparingVision, Rajiv served as Senior Director and Head of Chemistry, Manufacturing and Controls (CMC) at Voyager Therapeutics, a gene therapy company based in Cambridge, MA. In this role, he was responsible for CMC strategy and management of the company's entire gene therapy portfolio. Prior to Voyager, Rajiv was Director of Bioprocess Development and Manufacturing at Genocea Biosciences, where he led upstream and downstream process development and biochemistry groups for early- and late-stage recombinant-protein-based therapeutic vaccines. Prior to Genocea, Rajiv served as Head of Protein Sciences at LakePharma (now part of Curia), leading therapeutic protein production efforts for pre-clinical studies. Rajiv obtained his PhD in Life Sciences from Mumbai University in India, and did postdoctoral research at the Department of Biochemistry at the New Jersey Medical School and at the Department of Molecular and Cellular Biology at Harvard University. Rajiv is based in Massachusetts, USA.

• Gene Therapy Manufacturing

Dr. Patrick Garidel is currently employed as Head of Pharmaceutical TIP at Boehringer Ingelheim Pharma GmbH & Co. KG with a long history of developing biologics from the early phase to the commercialisation of blockbuster products. His activities are focused on the development biologics from the downstream process to drug product (liquid and solid formulations, freeze-drying). His expertise covers: development of drug delivery system and formulations, packaging/devices, process development, bio-analytic, and protein purification. He established innovative platform technologies for e.g., powder inhalation, gene therapy, in silico based predictive tools for molecule properties, particle analytics. Additionally, he is interested in the development of new concepts and strategies for protein purification, stabilisation, delivery, and protein/colloid chemistry in general. PG studied chemistry and biotechnology at the University of Kaiserslautern, pharmaceutical sciences and regulatory affairs at the University of Strasbourg and IP & innovation management at the University of Koblenz-Landau. He has a PhD in biophysics. During his university career, he took over various academic positions at the Institute for Pharmaceutical Technology and Biopharmacy, Physical Chemistry at the Martin-Luther-University Halle-Wittenberg, DESY/Hamburg, Rutgers University and Hospital for Special Surgery/New York.

• Formulation and Stability

Dr. Saurabh Gautam is a principal scientist at ViraTherepeutics GmbH, a Boehringer Ingelheim group of companies, leading the bioprocess development of viruses and vaccines. He has previously worked at Max Planck Institute of Biochemistry (Munich region, Germany) and obtained his Ph.D. from Indian Institute of Technology Delhi (India)

• Gene Therapy Manufacturing

Janet Glassford is an Expert Quality Assessor at the MHRA with a special interest in ATMPs. Her role includes the assessment of ATMP marketing authorisations, early access assessments, innovation licensing pathway applications and the provision of scientific advice, and support to the innovation office. Since joining the Agency in 2010, she has assessed a wide range of biological products, including numerous ATMPs (encompassing gene therapies, somatic cell therapy medicinal products and tissue engineered products). She has also contributed to various regulatory/scientific guidelines. Prior to becoming a regulator, she gained more than 18 years laboratory-based research experience. Her research interests and publications centred on the cell biology of haematological malignancies. During this time she acquired substantial hands-on experience of a wide variety of molecular and cell biological techniques relevant to ATMPs.

• Cell Therapy CMC and Analytics

Stephen is a lecturer in Digital Bioprocess Engineering specialising in the application of advanced data analytics and mathematical modelling to the biotechnology sector. His key areas of focus is related to digitalisation of biopharmaceutical operations through development of advanced data analytics, process analytic technology and advanced control solutions.

• Cell Culture and Bioproduction

Dr. Christoph Gstottner obtained his PhD in 2021 at the Leiden University Medical Center (Netherlands) under the supervision of Prof. M. Wuhrer. His PhD research was focused on the development of electrophoretic but also chromatographic methodologies for the in-depth characterization of biopharmaceuticals such as monoclonal antibodies or newer antibody formats. In his postdoc, he focuses on the development of new CESI-MS methods for the functional characterization of biopharmaceuticals and their affinity to Fc receptors.

• Analytics and Characterisation

No bio available.

• Gene Therapy CMC and Analytics

I am the inventor of two novel analytical technologies for characterising biopharmaceutical products: virus lasers are an exciting new class of ligand-binding assay in which the biorecognition probes generate a laser signal, and decay-associated chromatography is a label-free technique for quantifying proteins directly in mixtures. I am a UKRI Future Leaders Fellow hosted at the UCL Department of Biochemical Engineering and the founder of Roxijen.

• Analytics and Characterisation

Jorge Haller is the Director and Head of Analytical Development at Prevail Therapeutics (a wholly owned Subsidiary of Eli Lilly), a company dedicated to improving treatment for neurodegenerative diseases. Previously he worked at Regeneron Pharmaceuticals. He was a Postdoctoral fellow at Harvard Medical School and has a PhD in Physiology and Biophysics from Boston University School of Medicine. He has worked in several AAV drug programs, which are currently in clinical trials. He has served as invited expert panelist in AAV Critical Quality Attributes and Potency Assessment for the United Stated Pharmacopeia.

• Gene Therapy CMC and Analytics

Dirk Haubert works as Analytical Project Lead in the Biologics Process Development Department of Novartis Pharma AG in Basel, Switzerland. He is responsible for the analytical development and overall analytical CMC strategy for biological molecules in late-phase clinical development and market application phases. Dirk holds a PhD in Biology and Immunology from the Cologne University, Germany and brings more than 10 years' experience in the field of analytical development for classical biological molecules, biosimilars and cell and gene therapies.

• Analytics and Characterisation

Susanne Heider is currently leading the Upstream Lab Scale Bioprocess Development Team at Takeda at the facility in Orth in Austria. Together with her team, she focuses on upstream process development, as well as exploration of innovative upstream process solutions focused on automation and digitalization. Prior to joining Takeda, she pursued a scientific career in the field of virology and nanobiotechnology at the University of Veterinary Medicine in Vienna, Austria, and Chalmers University of Technology in Gothenburg, Sweden. Susanne holds a Master's degree in Bioprocess Technology and a PhD in Biotechnology.

• Gene Therapy Manufacturing

Dr. Stanislas Helle is an Expert in the analysis of bioproducts by mass spectrometry and capillary electrophoresis. He realized his PhD on plant proteomics and metabolomics in the University of Lille, France. He is now working as a post-doctoral researcher among the SSPC, The Science Foundation Ireland Research Centre for Pharmaceuticals, using his skills in mass spectrometry and capillary electrophoresis to monitor the quality of purified antibodies. His current project is a collaboration between the University of Limerick and 5 industrial partners, namely Pfizer, Eli Lilly, MSD, Janssen and BMS.

• Advances in Recovery and Purification

Christoph Herwig, bioprocess engineer from RWTH Aachen, worked in industry in the design and commissioning of large chemical facilities prior to enter his interdisciplinary PhD studies at EPFL, Switzerland in bioprocess identification. Subsequently he positioned himself at the interface between bioprocess development and facility design in biopharmaceutical industry. Since 2008, he is full professor for biochemical engineering at the Vienna University of Technology. The research area focuses on the development of data science methods for integrated and efficient bioprocess development along PAT and QbD principles for biopharmaceuticals. In 2013 he founded the company Exputec, which is now part of Korber Pharma, pioneering data science software solutions for the biopharma life cycle.

• Cell Culture and Bioproduction

After studying biotechnology I carried out my PhD thesis in the lab of Jan-Michael Peters at the IMP in Vienna working on the structural and mechanistic characterization of the anaphase-promoting complex. In 2008 I started as a Postdoc in the team of Ruedi Aebersold at ETH Zurich where I combined chemical crosslinking and mass spectrometry for the structural analysis of native macromolecular protein complexes and networks. This approach developed into a widely used method that I applied for studying the assembly of the kinetochore and its role in accurate chromosome segregation at the Gene Center in Munich from 2012 to 2021. Recently, I joined the Institute Krems Bioanalytics where I am heading the laboratory of Biomedical Mass Spectrometry with the goal of developing protein interaction analysis into diagnostic tools.

• Analytics and Characterisation

Rick Hibbert obtained his Wellcome Trust PhD from Oxford University investigating IgE antibody biology. He subsequently worked as a Post-doctoral Research Fellow at the Netherlands Cancer Institute, later combined with a funded MBA. He joined Genmab in 2013 and is currently Senior Director and Head of the CMC Science and Technologies Department in Utrecht, focused on early and late-stage CMC development of Genmab's antibody products.

• Advances in Recovery and Purification

Sophia Hober is Professor of Molecular Biotechnology at KTH, Stockholm, Sweden. The focus of her current research group is development of predictable and robust systems for protein purification and detection by protein design and various selection methodologies. Her key scientific achievements include design and development of gene fusion systems for selective ion-exchange purification and improvements of the alkaline tolerance of protein A for industrial purification of IgG (currently a product sold by GE-Health care). Also, a novel ligand for affinity purification of proteins has been developed that displays a calcium dependent binding, enabling mild elution from the column. Moreover, small bispecific protein domains with ability to strongly and selectively bind to two different proteins recently have been developed for use in diagnostic and therapeutic applications.

• Intensified and Continuous Processing
• Cell Therapy CMC and Analytics
• Cell Therapy Manufacturing
• Advances in Recovery and Purification
• Gene Therapy Manufacturing
• Gene Therapy CMC and Analytics
• Cell Line Development
• Cell Culture and Bioproduction
• Formulation and Stability
• Analytics and Characterisation

Margit Holzer is a biochemical engineer with extensive expertise in the development and implementation of biochemical/technological production processes. She holds a Ph.D. in biotechnology from the University of Natural Resources and Applied Life Sciences in Vienna (Austria). Margit has worked all over Europe for Boehringer Ingelheim and Novasep, she held various positions in R&D, production and manufacturing, quality, and technology, including several executive positions such as Technology Director. Amongst other achievements, she has led a successful FDA inspection on a pharma and biopharma production site as Quality Director. She has been involved in the process development of more than 50 different biopharmaceuticals of different origins (recombinant and non-recombinant cell cultures, yeasts, microorganisms, viruses, plants and fluids from vertebras). Currently, she works as Scientific Director at Ulysse Consult.

• Intensified and Continuous Processing
• Cell Therapy CMC and Analytics
• Cell Therapy Manufacturing
• Advances in Recovery and Purification
• Gene Therapy Manufacturing
• Gene Therapy CMC and Analytics
• Cell Line Development
• Cell Culture and Bioproduction
• Formulation and Stability
• Analytics and Characterisation

Microbial Platform DSP Global CMC Development

• Advances in Recovery and Purification

Working in the Analytical Chemistry Group in Regeneron Pharmaceuticals, Inc. Worked in Analytical Development in Biogen Inc. PhD of Biochemistry from Boston University

• Analytics and Characterisation

Thomas is the lead researcher for the UCL-Pall Centre of Excellence, established in 2018. He received his PhD in 2019 and was awarded a three-year UKRI Fellowship in 2021.

• Advances in Recovery and Purification

Over 20 years of experience in analytical and process development, and small scale manufacturing, as part of Astra Zeneca, NovoNordisk, BioInvent and Straumann. Experienced in development and manufacturing of antibodies and other therapeutic proteins, animal extract-based products and MSC. More recently focussed on quality assurance, aseptic production and biologicals. Currently Head of Manufacturing and Quality Manager at Amniotics (3 years).

• Cell Therapy Manufacturing

Ohnmar Khanal is a Senior Scientist in the downstream technology development team at Sparks Therapeutics. Ohnmar received a BS in Chemical Engineering from MIT and a PhD in Chemical Engineering from the University of Delaware in the lab of Professor Abraham Lenhoff. Her interest and expertise lie in designing novel separation strategies for various drug modalities, employing experimental and model-based approaches. Her previous work addresses the retention, adsorption, competitive binding, and transport of biomacromolecules in the realm of depth filtration and chromatography. She has developed novel methodologies and techniques using her fundamental understanding of protein transport and protein biophysics.

• Gene Therapy Manufacturing

Tony Bou Kheir leads the analytical development and Quality Control programme at Purespring therapeutics; developing new analytics to support product characterisation and release. Tony has over 10 years' experience in the design, development, and application of novel analytics to support product characterisation. Tony leads a team focused on improving AAV manufacture through the design and application of new technologies for in-process testing, and the development of more accurate and robust assays for product release. Tony's team also oversees assay qualification and technology transfer to 3rd party GMP facilities and CDMO's.

• Gene Therapy CMC and Analytics

Maura Kibbey is the Director of Biologics Marketing in USP's Global Biologics Department. Dr. Kibbey's team helps inform and raise awareness of USP's standards, educational courses, and stakeholder events. Previously, Maura directed a team of liaisons working with USP Expert Committees and Expert Panels for biologics, peptides, and antibiotics to develop standards that support biopharmaceutical quality assessment and development. Before joining USP, Dr. Kibbey worked for several biotechnology and diagnostic companies in the Washington, DC, area and at the National Institutes of Health. Her scientific expertise includes developing and validating many different assay types for measuring individual molecules, their activities, or binding interactions. She has published over 40 peer-reviewed articles and has been an invited speaker or workshop organizer for numerous scientific conferences.

• Cell Therapy CMC and Analytics

Dr Knevelman is the Vice President and Head of Process R&D at Oxford Biomedica (OXB), providing specialist expertise in all aspects of process development throughout her eight years with the company. Her main areas of responsibility include early and late phase process development activities encompassing platform process design & optimisation, scale-up, process characterization and technical support in the area of viral vector production/purification development for cell and gene therapy applications. The department works across multi functions to support both OXB's internal and third party collaborator product development pipeline. Prior to joining OXB, Carol worked for several years for Lonza Biologics both in the UK and US. Carol has an Eng.D in Biochemical Engineering from University College London (UCL).

• Gene Therapy Manufacturing

Julian Kopp conducted his Bachelor and Master studies at the University of Natural Resources and Life Sciences (BOKU), Vienna, in the field of Biotechnology between 2011-2017. During his studies, he did multiple internships at SANDOZ GmbH and AGES GmbH giving him an insight in (bio-)pharmaceutical industry and control authorities. After graduation, he performed his PhD Thesis at TU Wien in chemical engineering. He developed diverse cultivation modes and analytical tools to facilitate E. coli bioprocessing. After completing his PhD Thesis in August 2020, Julian started as Post-doctoral researcher in the Integrated Bioprocess Development group of Prof. O. Spadiut. Currently, he uses multivariate data approaches to improve inclusion body downstream processing.

• Intensified and Continuous Processing
• Gene Therapy Manufacturing

Sandra started her career after her apprenticeship at Hoechst AG in Frankfurt. For 10 years she worked at the Paul-Ehrlich-Institute in the research field of "Modified Vaccinia Virus Ankara" (MVA) and there worked on her bachelor thesis: "Construction and Characterisation of recombinant MVADE3L-LacZ. 2007 she changed to Sanofi. Since then, she works as a Lab Engineer and was focused on the protein purification process development. Her master's thesis describes the validation and implementation of qPCR-based monitoring of retrovirus-like particles. Currently, she supports Sanofi's digital transformation, focusing on the implementation of a globally deployed paperless lab system. She supported creation of experiment templates, connection to visualization tools (data lake) as well as inter-site alignment to switch to a digital way of lab working including the connection of lab equipment for an automated data transfer.

• Intensified and Continuous Processing

As head of downstream process modeling, Maximilian is responsible for Novasign's modeling projects in filtration, chromatography, and other DSP units, and helps to accelerate and better understand customers' bioprocesses by using advanced machine learning. He studied technical chemistry at TU Vienna and obtained his PhD from the University of Natural Resources and Applied Life Sciences. In his presentation, Maximilian will talk about predictive models and digital twins, and present showcases from upstream and downstream processing.

• Advances in Recovery and Purification

Dan Bach Kristensen holds a Ph.D. in biology and B.Sc. degree in chemistry. Dan is specialized in protein chemistry and mass spectrometry, which he initially applied in the field of proteome research in Japan and later in Denmark. For the last 17 years Dan has been working with analytical development in the biopharmaceutical industry, on projects ranging from early discovery through to product registration. Clinical indications include bleeding disorders, neutropenia, autoimmune diseases and oncology. Dan currently works as a Principal Scientist at Symphogen, which is specialized in the development of antibodies and antibody mixtures for the treatment of cancer.

• Analytics and Characterisation

Vijesh Kumar is a Lead scientist in the downstream technology development team at Sparks Therapeutics. He has previously worked as a researcher at the University of Delaware, US. He received his Ph.D. in chemical engineering from IIT, Delhi. Vijesh is an expert in the area of developing accurate mechanistic column models for preparative ion exchange chromatography with multiple impactful publications. Vijesh is also a leader in developing novel and high-resolution purification solutions to various challenges in different modes of preparative chromatography for industrial applications, including IEX, HIC, and Affinity for different modalities such as mAbs and AAVs. He has 15 years of experience in the realm of chromatographic separations.

• Gene Therapy Manufacturing

Dr. Kumar is a recognized global expert in Chemistry, Manufacture and Controls (CMC) Technical Development and GMP manufacturing. Prior to joining Genprex in September 2021, Dr. Kumar was Vice President, Global Head of Manufacturing, Supply Chain, and Strategy for Arcturus Therapeutics, Inc. Prior to that, Dr. Kumar was Vice President of CMC Technical Development & Manufacturing Operations at Oncoimmune Therapeutics, Inc., a private company that was acquired by Merck & Co. during his tenure there. Before that, he was Vice President, Head of Global Process Sciences and Clinical Manufacturing Operations at Rentscher BioPharma, SE. Previous to that, Dr. Kumar was with Anaptysbio, Inc., where he served as Senior Vice President, Head of Global CMC, Technical Development and Manufacturing Operations. Before that, Dr. Kumar held senior level positions of increasing manufacturing and technical operations leadership in global biopharmaceutical companies including Merck & Co., Inc., Sanofi Genzyme, Inc., Lonza Biologics, Inc., Sanofi Pasteur, Janssen Biotech (a Johnson & Johnson company) and Wyeth Lederle Vaccines, Inc.

• Gene Therapy CMC and Analytics

Christine Le Bec joined Sensorion early this year and is responsible for all CMC-related activities in process development and manufacturing with internal teams and external partners to support preclinical development through clinical development. Before, she was at Genethon for over 20 years as a scientist and headed the CMC Analytical Department. She has strong expertise in the characterization and release testing of gene therapy products, stability studies, interface with CMO for method transfer and validation, and analytical/QC testing. She has extensive experience in the development and qualification of analytical methods based on biochemical, biophysical, and cell-based assays to assess identity, potency, impurity profile, and safety. Before joining Genethon, she obtained her Ph.D. in Bioorganic Chemistry from Universite Pierre et Marie Curie (Paris VI) in 1993. She worked as a postdoctoral researcher at Thomas Jefferson University (Philadelphia, PA, US) and then at Institut Pasteur (Paris, France) in the field of synthesis, structural analysis, and in vitro evaluation of antisense DNA as therapeutic agents for cancer and AIDS.

• Gene Therapy CMC and Analytics

Dr. Lee is a Professor in the Department of Biological Sciences at KAIST (http://bs.kaist.ac.kr/~acelab/). He was a Scientific Director at the Section for CHO Cell Line Engineering, Novo Nordisk Foundation Center for Biosustainability, DTU. Dr. Lee received his B.S. and M.S. degrees in Chemical Engineering at Seoul National University, and PhD degree in Chemical Engineering at the University of Michigan. He joined KAIST in 1991. He has co-authored 257 research articles, currently serves as an Editorial Board Member for major biotechnology journals, and has served as an industrial consultant and collaborator to numerous biotechnology companies on CHO cell culture engineering for therapeutic protein production.

• Cell Line Development

Michael has 30 years' experience in regenerative medicine, during which he progressed 10 different cell-based products from the laboratory into clinic. As co-founder, he was jointly responsible for moving Intercytex from a pre-clinical research company, to an AIM-listed biotech with several cell therapy products in the clinic. He has extensive GMP manufacture expertise which includes management of several FDA/EMEA/MHRA licensed GMP facilities. Additionally, Michael has clinical, regulatory and logistic expertise and he has directly raised over $60m in equity and grant funding. In 2017, Michael received the 'Scottish Life-Sciences Entrepreneurial Business Leadership' award for 2016-2017. Michael is also a Fellow of the Royal Society of Medicine and Honorary Lecturer at the University of Aberdeen, School of Medical Sciences.

• Cell Therapy Manufacturing

No bio available.

• Gene Therapy CMC and Analytics

Rhys Macown, PhD, is a Lead Scientist in the Technology and Process Innovation team at Cell and Gene Therapy Catapult UK. Rhys earnt a BE(Hons) in chemical and process engineering at University of Canterbury (NZ) before starting his career with a PhD in Biochemical Engineering in Professor Nicolas Szita's group at University College London. Since joining the Cell and Gene Therapy Catapult in 2014, Rhys has been heavily involved in collaborative and core-funded projects developing pluripotent stem cell-based processes and has played a leading role exploring the 3D expansion of pluripotent stem cells as aggregates. He also has experience in process diagnostics, technology assessment, immunotherapy process development, and automation projects. Rhys now leads the Cell and Gene Therapy Catapult's Bioprocess Control program developing advanced control and manufacturing strategies for the rapidly expanding cell and gene therapy sector.

• Cell Therapy CMC and Analytics

Sheila Magil has over 40 years of experience in quality and analytical method development for biologics, peptides and small molecules. Her expertise includes quality assurance, protein and peptide biochemistry and analytical development. She was formerly Senior Manager of Analytical Development and Quality Control at Biomeasure, Inc., and previously held positions at Waratah Pharma, Alkermes, Bion and HHMI at Massachusetts General Hospital. Dr. Magil has implemented quality systems and has managed external analytical and QC activities for multiple biopharmaceutical products. Dr. Magil holds a PhD in Biochemistry from the University of Minnesota.

• TS1: Introduction to Bioprocessing

Ayda Mayer is the Executive Director of Vector Core at REGENXBIO, a leading AAV gene therapy company, supporting the company's broad pipeline of investigational AAV Therapeutics for rare and common conditions. In her role, she leads the efforts on high-throughput vector production, and early phase process and technology development, including cell lines and expression systems. Prior to joining REGENXBIO, Ayda was the Head of Cell Culture Sciences at MacroGenics. Earlier in her career, she led the Process Development team at Aeras and served as Director of Microbial and Cell Culture Development at GlaxoSmithKline and Human Genome Sciences in Biopharmaceutical Development, gaining expertise from early phase to commercialization of recombinant proteins and monoclonal antibodies. Ayda has a Ph.D. in Biochemical Engineering focusing on renewable resources from Purdue University.

• Gene Therapy CMC and Analytics

VP Global Regulatory Affaire for Orgenesis, previously held professional key roles in various biotech companies. Chaya has broad experience in setting global regulatory strategy in line with GMP requirements from early-stage development to approval. Her years (+25) of biotech/pharma industry cover a variety of functional areas including regulatory affairs, quality assurance and clinical trials. Chaya is a registered nurse, holds a bachelor's degree in Nursing (B.S.N.) and MPH from the Hebrew University of Jerusalem.

• Cell Therapy CMC and Analytics

Daniel Melotte is a Lead Scientist for Ipsen Biopharm and has worked in the BioPharmeceuitcal industry for 10 years. He specialises in the manufacturer of potent molecules within containment facilities, has responsibilities for developing and optimising all DSP steps, and mentoring new talent in the DSP team. He has developed and taken processes from pre-clinical through to Phase 3 clinical manufacture. His passion lies within automation, and he has developed multiple methods to aid potent molecule bioprocessing. These methods have been presented at Cytiva and BioProcessing Europe Conferences.

• Advances in Recovery and Purification

Ali Mohamed, Ph.D., Vice President, CMC, Immatics US Inc. was formerly the Senior Director of Manufacturing Operations/Manufacturing Development at PCT (now HCATS). Dr. Mohamed has nearly 20 years of experience in process development and GMP manufacturing of regenerative medicine, cell and gene therapy products at various CMOs and clinical-stage companies, including Lonza, Osiris Therapeutics, and AlloCure. The speaker holds a Ph.D. in Molecular Pharmacology from Medical College of Ohio and postdoctoral fellowship in Neuroscience and Neurobiology from Georgetown University.

• Cell Therapy Manufacturing

Massimo Morbidelli received his Laurea in Chemical Engineering at the Politecnico di Milano in 1977, and his PhD in Chemical Engineering at the University of Notre Dame in 1986. After his first appointments as professor at the University of Cagliari (Italy) and then at the Politecnico di Milano, he is, since 1997, Professor of Chemical Reaction Engineering at the Institute for Chemical and Bioengineering at ETH Zurich (Switzerland). His main research interests are in chemical reaction engineering, with particular emphasis on polymer reactions and colloidal engineering. This has evolved over the years in developing new processes for the production of polymer particles, ranging from the micro to the nano scale, exhibiting various types of functionalities and physico-chemical characteristics, including bio compatibility and degradation kinetics. Applications in various areas are considered including drug delivery, composite materials and treatment of oil reservoirs.

• Intensified and Continuous Processing

Jose P. B. Mota is a full professor of Chemical and Biochemical Engineering at the department of chemistry of NOVA School of Science and Technology of NOVA University Lisbon (Portugal), where he is responsible for the PhD program in Chemical and Biochemical Engineering. He heads the Laboratory of Adsorption Technology and Process Engineering (LATPE) at FCT-UNL. He leads the Thematic Line Energy - Clean & Renewable at LAQV, the Research Center for Green Chemistry and Clean Processes of REQUIMTE, and the Portuguese Network for Chemistry and Technology. He has authored over one hundred and fifty papers in the areas of separation science and transport phenomena. He is one of the World's Top 2% Scientists in Chemical Engineering according to the ranking published by Stanford University in PLOS Biology. He serves as an associate editor of Adsorption Science & Technology Journal, editorial member of open-access journals Molecules and Methane, and consulting editor of the Journal of Pharmaceutical Analysis. He has received several international awards and has served as a member of the Scientific Council of Sciences and Engineering (CCCE) of the Portuguese National Science Foundation (FCT/MCTES) and Board of Directors of the International Adsorption Society (IAS). He is a member of the scientific committees of the Fundamentals of Adsorption series of conferences and international Symposiums on Preparative and Industrial Chromatography and Allied Techniques (SPICA) and regular invitee of the International Symposia on Preparative and Process Chromatography held in the USA. He is the chairman of the SPICA 2022 symposium and of the 15th International Conference on Fundamentals of Adsorption to be held in 2025 by IAS.

• Advances in Recovery and Purification

Daniel is a Senior Scientist in the analytical group at the Centre for Process Innovation (CPI, UK). He has a degree in Biochemistry and a PhD in Biophysics from the University of Manchester (UK). He has experience of a variety of biochemical and biophysical techniques gained from working in Biopharma, academic and at large scale facilities.

• Intensified and Continuous Processing

Prof. Neubauer is head of the Bioprocess Engineering Laboratory at TU Berlin which is leading in bioprocess scale up and automated bioprocess development. The laboratory has been selected as a German key laboratory in AI. He is co-author in more than 250 publications and 20 patents and cofounder of the companies BioNukleo, Enpresso and Cell-tainer.

• Cell Culture and Bioproduction

Dr. Julia C. Neubauer (Fraunhofer IBMT) is CEO of the Fraunhofer Project Center for "Stem Cell Process Engineering" and Head of the department "Stem Cell & Cryo Technology". Among others, she is deputy coordinator of the imi-funded project EBiSC2. She studied Biology at the Julius-Maximilians-University of Wurzburg and received her PhD in 2012 after joining Fraunhofer IBMT five years before. During these years she spent also some time abroad, visiting the University of Stellenbosch/South Africa and the University of Coquimbo/Chile for research stays. Since 2012 she was leading the work group "Cryopreservation & Cell Culture Automation" at Fraunhofer IBMT in St. Ingbert. Since 2015 Julia Neubauer was appointed Head of Department and 2017 CEO of the Fraunhofer Project Center. Her main research topics are focused on establishing new automation procedures for the optimization of stem cell workflows using suspension bioreactors and robotic/microfluidic platforms in combination with new biomaterials. She is the author of more than 30 publications focused on cryopreservation of therapeutic relevant cells and automation of stem cell screenings. She has been a key scientist in all stem cell related projects of Fraunhofer IBMT.

• Cell Therapy Manufacturing

Christiane has spent 9 years at the UK medicines regulator MHRA, most recently as the Unit Manager of the Biologicals Unit. At the same time Christiane was a biologicals Senior Quality Assessor and the UK delegate at the EMA committee for advanced therapies (CAT). As UK CAT Rapporteur she was responsible for managing the portfolio of all UK ATMP products (cell and gene therapies). She was also the Rapporteur for the EMA CAT Gene Therapy Guideline, and a drafting group member in all other quality related ATMP drafting groups, including GMP for ATMPs. Prior to joining MHRA, Christiane worked with the UK regulator for the European Tissues and Cells Directive as a quality manager and inspector. Christiane joined Parexel in January 2021 as Vice President Technical for CMC and now works with developers to get cell and gene therapies into the clinic and to market. Since joining Parexel, Christiane has done a significant amount of work within the US regulatory system and can advise on EU, UK and US CMC considerations.

• Cell Therapy CMC and Analytics
• Gene Therapy CMC and Analytics

Prof Nielsen is Professor and Chair of Biological Engineering at UQ, Senior Group Leader at the Australian Institute for Bioengineering & Nanotechnology (AIBN), and Scientific Director at the Novo Nordisk Foundation Center for Biosustainability, DTU, Denmark. He is co-director of the Queensland Bioplatforms Australia Node (2008-), which provides systems and synthetic biology support to design and build cell factories for the production of fuels, chemicals and pharmaceuticals. In 2015, he was awarded the prestigious Novo Nordisk Foundation Laureate Research Grant to establish a group at the Center for Biosustainability in Denmark, where he subsequently took on the role as CSO during the successful rebid and then CTO to establish the local biofoundry. Professor Nielsen has published more than 250 papers and delivered more than 110 invited talks. He has served as Principal Investigator on grant programs totalling in excess of $500M, leading two major industrial biotechnology initiatives and serving as subprogram lead on several others.

• Cell Line Development

I am a research scientist who is deeply fascinated by the behaviour of proteins in cells, in living systems and in recombinant engineered systems. The junction of biology, chemistry and physics is of particular interest to me and is manifest in my many collaborative relationships in Europe and the US. I am also a Science Foundation Ireland funded investigator with BEACON, the Bioeconomy Research Centre, that enables me to use my expertise in protein engineering to drive creation of value in the circular economy, ensuring that excellent science creates products and technologies with sustainable properties, and to further enhance the reputation of UCD as Ireland's number one university.

• Advances in Recovery and Purification

Rui Oliveira is currently Associate Professor of Chemical and Biological Engineering at NOVA University Lisbon, Portugal. He is the head of the Systems Biology and Engineering lab and the head of the integrative research lab in Bio-Chemical Process Engineering (BCPE), REQUIMTE, a consortium of Portuguese universities. The main scientific research areas are Systems Bioengineering, development of algorithms in the context of Industry 4.0, development of platforms for in silico culture media optimization and customization (culture media 4.0), development of process modelling, optimization and control (M3C) methods for Industry 4.0, Theoretical development of hybrid modelling systems.

• Cell Culture and Bioproduction

Ioannis Papantoniou is an Associate Professor and Head of the Tissue Engineering Lab of the Skeletal Biology and Engineering Research Center, Department of Development & Regeneration and part of Prometheus, the Leuven R&D interdisciplinary division for skeletal tissue engineering. He is member of the board of the TERMIS-EU society. His research aims to address challenges regarding automated manufacturing of organoid-based implants supporting their viable translation in clinics. His research has been supported by EU as well as national funding bodies.

• Cell Therapy Manufacturing

Cristina Peixoto graduated in Applied Chemistry (Branch Biotechnology) New University of Lisbon and she holds a PhD in Engineering Sciences from Instituto de Tecnologia Quimica Biologica (ITQB) from New University of Lisbon. Working in Animal Cell Technology field since 1996, her PhD contributed to the establishment of several scalable purification processes for complex biopharmaceuticals, mainly virus and virus like particles for vaccine and gene therapy. Cristina coordinated several research contract projects with Industrial partners, some of the processes developed are nowadays in GMP for phase I and II and she published over 60 manuscripts in refereed international journals.

• Gene Therapy Manufacturing

After obtaining her Master's degree in Drug Development at Ghent University in 2012, Karen started her PhD at the Laboratory of General Biochemistry and Physical Pharmacy. During her PhD she studied drug delivery barriers at the back of the eye in context of nanoparticle delivery to the retina. Having obtained her PhD in 2018, she now continues her ocular research as postdoctoral researcher in the same research group where she investigates innovative approaches to overcome the inner limiting membrane as a barrier for nanoparticle and cell delivery.

• Formulation and Stability

No bio available.

• Cell Culture and Bioproduction

Ines Pinto is a Postdoctoral Researcher in the Division of Nanobiotechnology at KTH Royal Institute of Technology (Stockholm, Sweden) with 8 years of expertise in microfluidics with a focus on lab-on-a-chip systems for chromatography and biosensing applications. She has a background in Biological Engineering and received a PhD degree in Biotechnology and Biosciences from Instituto Superior Tecnico (Lisbon, Portugal) in 2018. During her PhD she worked on the development of microfluidic devices for high throughput screening of downstream processing conditions for monoclonal antibodies. Since 2018, Ines has been involved in the European Project iConsensus, where she has been mostly working on the miniaturisation of immunoassays for the at-line detection of relevant protein analytes during cell cultivation processes. Her research work has resulted in more than 20 peer-reviewed publications.

• Analytics and Characterisation

After studying at ENS Cachan (now Paris-Saclay), Arnaud Poterszman completed his PhD from Strasbourg University and joint the CNRS one year later. He holds a Research Director position and performs his studies in the Department of Integrated Structural Biology at IGBMC, Illkirch France. He has a dual expertise in Structural and Molecular biology with insights on expression technologies and sample preparation. His research is focused on eukaryotic multi-protein complexes involved in transcription regulation and DNA repair by nucleotide excision, particularly, the transcription/DNA repair factor TFIIH and its partners (Orchid 0000-0002-6702-5777)

• Cell Line Development

Philip is an experienced research scientist familiar with high-throughput process development, design of experiment approaches to process optimisation and process scale up and validation. At CPI Biologics, Philip manages the technical team, working across mammalian, microbial, viral and cell-free projects.

• Cell Line Development

Toby Proctor is Head of Manufacturing Science & Technology at Achilles Therapeutics UK Ltd, an AI-powered precision cell therapy company developing adoptive T cell therapies for the treatment of solid tumours. He obtained his EngD in Biochemical Engineering from University College London, UK, developing novel, closed systems for the production of tissue engineered AT(I)MPs. Toby acts as the technical lead for internal, device development activities at Achilles Therapeutics and has experience transitioning projects from conceptualisation through to production. As Head of MSAT at Achilles Therapeutics he oversees a multidisciplinary team of engineers and scientists focused on bioprocess innovation, alongside the integration of new technologies and development of pipeline products.

• Cell Therapy Manufacturing

Raj K. Puri, MD, PhD is an Executive Vice President, Regulatory Strategy and Translational Medicine at Iovance Biotherapeutics, San Carlos California. Dr. Puri joined Iovance in March of 2022. He has decades of experience with the evaluation and regulation of advanced therapies including cell and gene therapy, cancer vaccines, and cellular immunotherapy. Dr. Puri previously spent 33 years working at the U.S. FDA, including more than 19 years as the director of the Division of Cellular and Gene Therapies (DCGT) in the Office of Tissues and Advanced Therapies in the Center for Biologics Evaluation and Research. He was also a Chief of Tumor Vaccines and Biotechnology Branch within DCGT and oversaw research programs of 13 Principal Investigators in DCGT. As a principal investigator and throughout his career, Dr. Puri has led research in the field of cancer therapies. He has published more than 300 research and review articles and awarded numerous patents. Dr. Puri was also trained at the National Cancer Institute's Surgery Branch, where he worked in the laboratory of Dr. Steven Rosenberg on adoptive immunotherapy approaches for cancer. He received his M.D. from the University of Juarez Medical School Institute of Biosciences and his Ph.D. in Medical Sciences from the Central Drug Research Institute, Lucknow.

• Cell Therapy CMC and Analytics

Dr. Andy Racher has more than 34 years of experience in developing processes, expression systems, and cell lines for mammalian cell manufacturing. Before moving into the cellular agriculture field Andy held a number of roles at Lonza Biologics in Process Development and R&D, leading development of the industry-leading GS-CHO system based upon CHOK1SV and undertaking projects for Lonza's commercial customers. Today, Andy works for HigherSteaks, a rapidly growing start-up company developing bacon and pork belly cell-based meat products from porcine iPSCs.

• Cell Culture and Bioproduction

Dr Qasim Rafiq joined University College London in 2017 as an Associate Professor in Cell and Gene Therapy Bioprocess Engineering in the Department of Biochemical Engineering. He is a multidisciplinary engineer working at the life science, engineering and commercial interfaces with a research focus on the bioprocessing, automation and biomanufacture of cell and gene-based therapies. He currently leads a research portfolio of > £5M as Principal Investigator and leads a dynamic interdisciplinary research group that collaborate internationally with high-calibre academic institutions, industry partners, and leading clinicians. He is also Programme Director of the new Manufacture and Commercialisation of Stem Cell and Gene Therapies MSc programme. Qasim is both a Chartered Engineer (CEng) and Chartered Scientist (CSci) and sits on multiple scientific and engineering committees including the IChemE Biochemical Engineering Subject Interest Group, British Standards Institute Biotechnology Committee and the BIA's Cell and Gene Therapy Advisory Committee.

• Cell Therapy CMC and Analytics

No bio available.

• Cell Culture and Bioproduction

No bio available.

• Gene Therapy Manufacturing

James (Jay) has been doing downstream process development for 16 years. Most recently, at Regeneron where he is an Associate Director in Pre-clinical Manufacturing and Process Development. His interests include high-throughput screening, mechanistic modeling, bispecific purifications, and host cell protein clearance.

• Advances in Recovery and Purification

After Dietmar's study of Chemistry with a focus on analytics at the University for Applied Science Reutlingen, Germany with a graduate's degree in engineer and chemistry, Dietmar was engaged at TuV Stuttgart as a specialist in environmental safety. Since 1988 he has worked at Roche Diagnostics. At present, Dietmar is heading the Characterisation Analytics department of Pharma Development at the Roche facility in Penzberg, Germany. In 2015 he got his PhD (Glycan analysis of therapeutic antibodies) from the University of Amsterdam. His responsibilities are the characterization and comparability of all large molecules in development and production for Roche Pharma Europe. The techniques used in his lab are including mass spectrometry, HPLC-MS, and spectroscopic methods for release and process development. His special focus is on glycobiology and glycan analysis with methods like HILIC/RP-UPLC after AB-labeling, HPAEC-PAD, CE, and mass spectrometric-based methods, including high-throughput techniques.

• Analytics and Characterisation

Johan Rockberg is a Professor in Antibody Technology and Directed Evolution at KTH Royal Institute of Technology in Stockholm. As an elected member of the Young Academy of Sweden, he is engaged in research policies, innovation and education topics. His research expertise covers methods for discovery and upscaled production of biological drugs of protein and viral nature. He is director of AAVNova, an academia industry consortia aimed at developing next generation gene therapy manufacturing platforms for a wider access to curative treatments. Johan is a co-funder of four spin-out companies related to his research in Stockholm, Uppsala and Seoul.

• Cell Line Development

Miguel A. Rodrigues is a Professor of Chemical Engineering at IST (University of Lisbon). He graduated in Biological Engineering (UAlg) and received his PhD in Chemical Engineering (IST) in 2006. Before joining IST as a research fellow (in 2009) he was an invited scientist at the University of Texas at Austin.

Miguel A. Rodrigues is author of several publications, patents and a co-founder of Smartfreez, a startup company that is now shaping the cryopreservation scene of the biopharma industry.

• Formulation and Stability

Qian Ruan, Ph.D., is the Vice President of Technical Operations and Manufacturing of Arcturus Therapeutics. Dr. Ruan is responsible for mRNA drug substance and LNP drug product productions at CMOs. Dr. Ruan has extensive experience in bioprocess development from preclinical to licensure. Prior to Arcturus, Dr. Ruan worked at Emergent BioSolutions/PaxVax Inc. as Sr. Director of Process Development and Clinical Production. She has successfully built and led the team developed/manufactured/tech transferred oral delivery vectors and injectable virus-like particles for vaccines. She was the main contributor for multiple Investigational new drug (IND) and Biological Licensure Application (BLA) submissions. Prior to Emergent BioSolutions/ PaxVax Inc, she worked for the Center of Cell and Gene Therapy at Baylor College of Medicine and developed early phase gene therapy drugs with adenovirus, herpes, and retrovirus platform technology. She published multiple articles and was the co-author of chapter "Purification of Adenovirus" in the book Adenoviral vectors for Gene Therapy. Dr. Ruan holds a Ph.D. and a Bachelor's degree in Biochemical Engineering from South China University of Technology.

• Gene Therapy Manufacturing

Florence holds a PhD in Molecular and Cellular Biology from Strasbourg University. She gained considerable experience in product development and regulatory affairs, bringing many of the early cell and gene therapies from the bench to the clinic in the early 2000s at TNO in Leiden/Zeist (the Netherlands). She joined uniQure (Amsterdam, Netherlands) in 2009 where she was instrumental in the approval of Glybera (first gene therapy in the EU) in 2012 and supported the development of a number of AAV-based gene therapy vectors for various disease areas. From 2014 to 2021 she was Director Global Regulatory Affairs CMC Cell and Gene Therapies, where she led the submission and approval of Kymriah (first CAR T product) for the treatment of acute pediatric leukemia and adult lymphoma in the US, Europe, Japan, and many other regions. She was also the regulatory CMC lead in the approvals of Luxturna and Zolgensma. She recently joined Ridgeline Discovery.

• Cell Therapy CMC and Analytics

After his PhD in physical chemistry & soft matter at Wageningen University in 2014, he joined several international research institutes in Ireland, USA and Denmark, where he worked on development and characterization of novel protein materials for food and pharmaceutical applications. After his postdoctoral training, he started as analytical scientist at Dr. Reddy's research & development in The Netherlands. In 2018, he moved Synthon as biophysical scientist, and had worked at team of extended characterization of monoclonal antibody and antibody-drug conjugate for 1 year. His current role is to support bioanalytical and research activities by building state-of-art level of knowledge in extended characterization of biopharmaceuticals and to implement the current science and/or new technologies for biopharmaceutical development at Byondis.

• Formulation and Stability

Fay Saunders is Director of Mammalian Cell Culture Process Development in the UK, having overall responsibility for cell line development and process development activities.  Fay has over 20 years' industrial experience, and has led the development of FDB's Apollo™ X CHO expression platform. She has a Ph.D in Biotechnology from the Open University, investigating the role of chromatin modifying elements on mAbs production in CHO cells.

• Cell Line Development

Johannes holds degrees in Physics and Biomedical Engineering with a major in Computational Biology from Technical University of Vienna. After having supported Takeda in various PAT & QbD projects as an external consultant, he joined the Pharmaceutical Sciences Team within Takeda R&D in May 2019. As Fellow for Automation & Control, one of his responsibilities is - in close collaboration with the subject matter experts - the design and implementation of advanced process control & automation architectures.

• Intensified and Continuous Processing

Dr. Stefan R. Schmidt MBA currently serves as Head of Operations/COO at BioAtrium AG, a joint venture of Lonza and Sanofi in Visp, Switzerland. Previously he held the position as CSO and other senior executive roles at Rentschler Biopharma with overall responsibilities for development and production for more than 5 years. Before that, he was CSO at ERA Biotech in Barcelona, directing the company's R&D efforts. Prior to that, he worked for 7 years at AstraZeneca in Sweden where he led the unit of Protein Sciences as Associate Director. He started his leadership career at Biotech companies in Munich where he built up protein biochemistry teams for Connex and GPC-Biotech.

• Intensified and Continuous Processing

Ricardo Silva received his PhD degree in Chemical and Biochemical Engineering from New University of Lisbon in 2013. His studies focused on the development and optimization of countercurrent adsorption processes for purification of (bio)pharmaceutical products. Since 2014 he is a senior scientist at Animal Cell Technology Unit in iBET, pursuing the development of continuous purification processes and identification of new purification strategies for vaccines, gene therapy vectors and cell-based products.

• Gene Therapy Manufacturing

Andrew has over 30 years' design and operational experience in the biopharmaceutical industry, with direct responsibility for manufacturing, logistics, maintenance, and capital programme management. He has developed Biopharm Services into a leading provider of bioprocess modelling and knowledge management tools that support bioprocess innovation. Prior to Biopharm Services, Andrew was Director of Engineering and Logistics at Lonza Biologics, and holds a M.Sc. in Biochemical Engineering from UCL. He was a finalist in "The Manufacturing Processing Thought Leader of the Decade" category at the 2012 BioProcess International Awards and is a Fellow of the Royal Academy of Engineering.

• Intensified and Continuous Processing

Katarzyna Sobkowiak received her PhD in Molecular Biology at University of Geneva in 2016. Katarzyna has a strong background in molecular biology and mammalian cell culture. In 2018, Katarzyna has moved to biopharmaceutical industry. She started as Cell Line Development Scientist at Merck Serono SA (affiliate of Merck KGaA). Currently, she works as Scientist in Cell Line Technology Innovation group at Merck Serono, where she is involved in evaluating new technologies and developing new protocols for improving and accelerating CLD workflow. Since 2021, she has started to work on stem cell culture and differentiation.

• Cell Line Development

Dr. Michael Sokolov is co-founder and COO of DataHow AG, a spin-off company from ETH Zurich specialized on process data analytics and modeling with a particular focus on the biopharmaceutical and chemical domains. He also holds a lecturer position for statistics for chemical engineers at ETH.

• Intensified and Continuous Processing

Eva is the Co-Founder and CEO at Fermify. Fermify is an Austrian-based start-up that develops an innovative and fully digitized platform to produce cheese proteins. Fermify purpose is to program microorganisms to develop and practice their skill set to produce casein proteins - and put cows out of work. Our customers consist of local and international cheese producers, CPGs, as well as governments. They receive a fully regulated, scalable production platform for the entire value chain of microbial dairy production: from the programmed microorganisms to the fully purified target proteins in order to produce cheese proteins in-house. Before Fermify, Eva was Co-Founder and CPO at the Belgian-based cultured meat company Peace of Meat that has been fully acquired in 2021. Eva enjoys working from exotic places all around the world, reading and supermarket sightseeing.

• Cell Culture and Bioproduction

Oliver Spadiut completed his PhD in Biotechnology at BOKU University, Vienna, Austria, in 2008 before doing a 2-year PostDoc at KTH, Stockholm, Sweden. Since 2010, he has been employed as University Assistant in Biochemical Engineering at TU Wien, Vienna, Austria. In March 2015, he got his Habilitation in "Biotechnology" and is currently Associate Professor and PI of the research group "Integrated Bioprocess Development." He has published more than 150 papers in reputed journals and is serving as a peer-reviewer for 80 scientific journals.

• Gene Therapy Manufacturing

Mattia Sponchioni received his Master of Science in Chemical Engineering in 2015 with a grade of 110/110 cum laude and his PhD cum laude in Industrial Chemistry and Chemical Engineering in 2018, both at Politecnico di Milano. After his PhD, Mattia spent one year as a post-doc at ETH Zurich in 2019, working on the development of continuous countercurrent chromatographic processes for the purification of biopharmaceuticals, from therapeutic proteins to oligonucleotides. From 2020 to the present he is an assistant professor at the Department of Chemistry, Materials and Chemical Engineering "G. Natta" at Politecnico di Milano. Here, Mattia Sponchioni is leading the group of biomanufacturing, active in the development of continuous perfusion processes for the production of mRNA and bioplastics via fermentation and in the conversion of the traditional single-column batch chromatographic purifications into continuous countercurrent processes based on two twin columns. The vision of the group, inspired by the principles of Industry 4.0, is towards process intensification, to be achieved through both continuous processes and integrated manufacturing, as a way not only to increase productivity but also the sustainability of biomanufacturing, by reducing the wastes of buffers and feedstocks in the direction of a reduced environmental footprint.

• Intensified and Continuous Processing

University Professor at the Department of Biotechnology (BOKU), Head of the Institute of Bioprocess Science and Engineering, Head of working group fermentation technology and principal investigator in the Austrian Center of Industrial Biotechnology (ACIB). The working group has established an integrated systems approach for bioprocess development and is focused on the implementation of PAT and QbD concepts in bioprocessing and rational host cell design. CHO, E. coli, insect cells and vero cell lines are used as expression systems for production of a representative set of biopharmaceuticals (mABs, Fabs, scFvs, VLPs, viruses, DNA.

• Intensified and Continuous Processing

Dr. Svilenov is currently an Associate Professor at the Faculty of Pharmaceutical Sciences, Ghent University. His research interests are in the development, formulation and manufacturing aspects of biotherapeutics. Before joining UGent, Dr. Svilenov was a postdoctoral researcher funded by a Peter and Traudl Engelhorn Fellowship and a grant from the Else Kroner-Fresenius Foundation in the group of Prof. Johannes Buchner at the Technical University of Munich. From 2016 to 2019, Dr. Svilenov did his PhD training supported by a Marie Sklodowska-Curie Fellowship under the supervision of Prof. Gerhard Winter at the Ludwig Maximilian University of Munich. He defended his doctoral thesis with the highest distinctions in Germany (summa cum laude) and received the AbbVie prize and the Carl-Wilhelm-Scheele of the German Pharmaceutical Society for his work. Dr. Svilenov is a pharmacist by training.

• Formulation and Stability

Greg serves as Chief Manufacturing Officer at Translate Bio, a sanofi company, where he is responsible for strategic oversight for all aspects of cGMP CMC operations, including clinical supply, analytical testing, quality, and engineering. Prior to TBio, Greg was Vice President of Technology and Chief Engineer at Seer, a life sciences and health data company using nanotechnology for proteomics and biomarker discovery. Prior to Seer, Greg was Vice President of Nanomedicine Development and Manufacturing within Pfizer's Pharmaceutical Sciences group, leading the development and manufacturing of novel nanoparticle drug products. Over his 20+ year career in the drug delivery field, Greg had various roles leading the pharmaceutical development of complex formulations, including numerous nano- and microparticle based systems.

• Intensified and Continuous Processing
• Cell Therapy CMC and Analytics
• Cell Therapy Manufacturing
• Advances in Recovery and Purification
• Gene Therapy Manufacturing
• Gene Therapy CMC and Analytics
• Cell Line Development
• Cell Culture and Bioproduction
• Formulation and Stability
• Analytics and Characterisation

Dr. Shahid Uddin is currently Director of Drug Product, Formulation & Stability within the CMC department at Immunocore. His team is responsible for bringing research candidates into clinic and commercialization. Technology is focused around developing ImmTAC as therapeutic agents for different disease models. Prior to this he held the position of Head of Formulation at MedImmune (AstraZeneca) where he supported the biologics portfolio covering Monoclonal antibodies, Peptides, bispecifics, and other proteins. He has extensive experience in pre-formulation/formulation, forced degradation, delivery of biologics both for early and late-stage programs.

• Formulation and Stability

Dr Joaquim Vives is a Biochemist, MSci in Biotechnology and PhD in Biochemistry (Universitat Autonoma de Barcelona, UAB, Spain) with extensive experience in the R&D biotech sector, both in private and academic environments, where he focused on the optimisation of cellular processes towards A) high yield production of diagnostic and therapeutic molecules, and B) the development of methods to manufacture cells for drug screening and therapy, in compliance with regulatory and pharmaceutical quality standards. Dr. Vives conducted post-doctoral research at the Institute for Stem Cell Research (University of Edinburgh, UK) in 2003, then moved to Stem Cell Sciences Ltd (Cambridge, UK) in 2006, and joined Banc de Sang i Teixits (Barcelona, Spain) in 2008, where he leads a Research Group focusing on the development of Advanced Therapy Medicinal Products from bioprocess design and validation to early phase I/II clinical trials. Dr. Vives collaborates with national and international institutions and is associated to the "Musculoskeletal Tissue Engineering Group" (Vall d'Hebron Institut de Recerca, VHIR, Barcelona, Spain), recognised as a Consolidated Research Group (2017SGR719). He is also an associated lecturer at the UAB Faculty of Medicine and coordinates the "Official master's degree in Transfusion Medicine and Cellular and Tissue Therapies", a joint degree with Leiden University Medical Centre (LUMC, The Netherlands). He is engaged with scientific communication (e.g. TEDx on Innovative Therapies at https://youtu.be/qfV5IxdLpSg).

• Cell Therapy Manufacturing

Dr. Bernd Voedisch studied Biotechnology at Braunschweig University of Technology in Braunschweig, Germany. He did his PhD in the field of recombinant antibody technologies and then joined the Novartis Institutes for Biomedical Research (NIBR) in Basel, Switzerland, as a Postdoc. He stayed as a lab head in the Biologics protein production platform, providing project teams with proteins and recombinant cell lines enabling discovery and characterization of various therapeutic protein classes (i.e., antibodies, multi-specifics, and non-antibody therapeutic proteins). He then switched to the cell line development unit where his additional responsibilities include the early assessment of Biologics candidates in the CHO expression system and the generation of monoclonal CHO cell lines for Biologics manufacturing for clinical and market supply.

• Cell Line Development

Thomas M. Waerner, PhD is Senior Principal Scientist and Laboratory director at the department of Analytical Development Biologicals at Boehringer Ingelheim Pharma GmbH & Co KG in Biberach, Germany. He takes responsibility for the control strategy of Host Cell Proteins (HCPs) and other biological process-related impurities for Biologicals from preclinic to marketing. Thus he is interacting closely with production units, customers, experts from other companies, and authorities. His lab focus is on the development, validation, and use of different immunological impurity tests including HCP assays. Since 1997, Thomas oversees how to develop and market biological products by accompanying responsible positions in research, development, production, analytical project management, and analytics at Boehringer Ingelheim in Austria and Germany. He received his Diploma Thesis and PhD in immunology, cell biology, and biotechnology from the University of Stuttgart Germany.

• Analytics and Characterisation

Ian Walsh is part of the Analytical Science and Technologies division and the leader of the GlycanAnalytics group. Ian has published 45 peer-reviewed articles in the past 15 years in the glycobiology and computational biology fields. He is developing wet lab and computational methods for more efficient and accurate carbohydrates analysis using state-of-art instrumentation like liquid chromatography, mass spectrometry, capillary electrophoresis, ion mobility and combinations thereof. He is also focused on the creation of novel adaptive machine learning and other computational modelling tools to: help understand bioprocessing data, develop real-time models of the bioprocess to predict the quality of cell cultured therapeutics and control the quality of the same therapeutics. Ian has skills in computer science, machine learning, statistics, mathematics, software engineering as well as biology.

• Analytics and Characterisation

Dr. Warren has 28 years of experience in the development, manufacturing, and commercialization of gene therapy viral vectors and live viral vaccines, with applied focus on bioprocess development and CMC Development Strategy. At Ultragenyx, he leads a team of 86 scientists and engineers, responsible for all early- and late-stage Process and Analytical Development of AAV portfolio products as well as Pilot Scale Manufacturing in Woburn, MA. Before coming to Ultragenyx Jim held senior CMC leadership positions at Homology Medicines, bluebird bio, Shire, and Merck & Co., leading process development and manufacturing teams responsible for development of several clinical candidates as well as the licensure of RotaTeq®, Varivax®, ProQuad®, and Zostavax®. Dr. Warren holds BS/MS degrees in Biotechnology from William Paterson University and a PhD in Molecular and Cellular Biology from Lehigh University.

• Gene Therapy Manufacturing

Paul Wassmann, Ph.D., Senior Principal Scientist, NIBR Biologics Center (NBC), Novartis Pharma AG, Switzerland Analytical technology and strategy lead for NBEs at the Characterization/ Formulation/ Bioinformatics unit (CFB). This role includes evaluation and coordination of implementation of appropriate innovative and strategic concepts in analytical space for challenging and completely new Biologics modalities with main focus on liabilities evaluation of Biologics molecules and their developability assessment. Prior industry experience includes Project management for Biosimilar projects at Solvias AG, Switzerland, and Scientific role in Antibody Engineering and Analytics departments at Glenmark SA, Switzerland. Holds a doctorate in Structural Biology from Biozentrum Basel, Switzerland.

• Analytics and Characterisation

Tobias has a 14 year track record in innovating equipment in the Drug Product sector of the pharmaceutical industry. He holds a PhD in biotechnology, a master's degree in pharmaceutical chemistry and an engineering degree in chemistry. He has been a scientist at Roche responsible for Drug Product Processing Innovation, a CMC leader at Idorsia and heads the department of preclinical galenics at Idorsia since 2019. He issued more than 10 patent applications. He makes things happen with great passion, enjoys taking challenges himself and giving others opportunities that challenge them to exceed themselves.

• Formulation and Stability

Prof. Dr. Dr. Rolf G. Werner is Honorary Senator of University of Tubingen and Professor for Industrial Biotechnology. After his promotion at University Tubingen he spent more than three years in academia at Max Planck Institute for Molecular Genetics, Berlin, Germany and Massachusetts Institute for Technology, Cambridge, USA and has more than 35 years experiences in industry at Boehringer Ingelheim in top leading positions. He was responsible for the development and registration of the first, genetically engineered, protein therapeutic from mammalian cell culture: tissue plasminogen activator for myocardial infarction and stroke. More than 20 therapeutic proteins and monoclonal antibodies have been developed, manufactured and regulatory approved under his responsibility. He designed an operated the first 6x15.000 L mammalian cell culture plant in Europe, constructed in 18 months. Under his supervision, also processes for viral therapeutics and vaccines have been developed. He is consulting biopharmaceutical, viral therapeutic and vaccine companies in Europe and Asia in all aspects of research and production technologies as well as conceptual design of GMP biotech plants. His achievements are recognized by the Prize of the City of Vienna, Austria, for outstanding scientific work as well as from the Zhejiang Government, China, as Hangzhou Qianjiang Distinguished Expert in Biotechnology. He is National Foreign Expert of People Republic of China.

• Cell Therapy Manufacturing

I studied Biotechnology at the Technical University of Brunswick in Germany between 1998-2004 which I finished with a diploma degree. I then did my PhD in the downstream group led by Prof. Juergen Hubbuch at the Research Centre in Juelich, Germany. The project which focussed on high throughput screening techniques in downstream processing was co-funded by Novo Nordisk where I was hired in 2007. I received my PhD (in German Dr.-Ing.) in 2008. Since 2007 I have worked in different positions in Novo Nordisk within the field of manufacturing/downstream processing of drug substances. I now work as Principal Scientist in a Manufacturing Development department with a focus on chromatography and filtration looking for faster, integrated processes and suitable in/on-line analytical techniques.

• Advances in Recovery and Purification

After gathering experience for several years in the contract manufacturing area of biopharmaceuticals, Dr. Stefan Wieschalka joined Boehringer Ingelheim Pharma GmbH & Co. KG in 2019. He is head of lab of an early-stage upstream process development group, developing CMC processes for Phase I clinical supply of innovative company-owned new biological entities. Before entering the pharmaceutical area, he was awarded by Innovationsfonden and held an industrial Postdoc position at the Novo Nordisk Foundation Center for Biosustainability in Denmark. He studied biology at the University of Ulm, Germany and obtained his PhD at the Institute of Microbiology and Biotechnology on bio-based production of chemical building blocks and biofuel.

• Cell Line Development

Helen manages the Synthetic and Mammalian Upstream team at CPI Biologics, that is responsible for delivery of a range of collaborative and commercial projects. These encompass a diverse range of product types including monoclonal antibodies, viral vectors and nucleic acids expressed in mammalian and/or cell-free systems. Helen specialises in development and optimisation of processes, and associated molecular methods, for production of AAV gene therapies. This includes high throughput process development, design of experiment approaches to process optimisation and up to 200L scale production. Prior to joining CPI in 2017, Helen worked as a post-doctoral researcher at the University of Manchester using mammalian cell culture and in vivo models to study the inflammatory microenvironment in tumours. Helen holds a PhD in Molecular Cancer Studies from the University of Manchester.

• Gene Therapy CMC and Analytics

Sofia Zaichick, PhD, Lead researcher in the Process Development group, Gene Therapy Program (Head: Dr. James M. Wilson ), Department of Pathology and Laboratory Medicine and the University of Pennsylvania (USA). My scientific interests include gene therapy, virology, and neurodegeneration. I am currently working on development of a stable cell line for the rAAV production that does not involve any transient transfection or infection with a helper virus.

• Cell Line Development

Bachelor and Master degree in Biochemistry performed at the University Ulm. Dissertation (currently in preparation) about cell line engineering and bioprocessing conducted at the University of Applied Sciences Biberach in the Institute of Applied Biotechnology (IAB) in the lab of Prof. Dr. Kerstin Otte. First work experience through internships at Sartorius-Stedim Cellca GmbH and Novartis AG. Started as Post Doc in September 2021 in the Cell Biology lab at Boehringer Ingelheim Biberach.

• Cell Line Development

No bio available.

• Analytics and Characterisation

No bio available.

• Cell Therapy Manufacturing

Dominik Zurcher is a Ph.D. student in the group of Prof Paolo Arosio at ETH Zurich. Together with an industrial partner, he develops microfluidic techniques and other automatable approaches to assess and optimize the interfacial stability of therapeutic protein formulations. He completed vocational training in the financial industry before receiving his B.Sc. and M.Sc. degrees in chemical and bioengineering from ETH Zurich. During his studies, he interned in the group of Prof Paolo Arosio to work on the dynamics of Protein Liquid-Liquid Phase Separation in microfluidic droplets. He then joined the research group of Prof Tuomas P. J. Knowles at the University of Cambridge for his master's project to investigate antigen-antibody interactions using microfluidic techniques. After one year of project-based work in the R&D and marketing department of a major consumer goods company, he re-joined the Biochemical Engineering Laboratory in September 2020 to pursue his Ph.D. studies.

• Formulation and Stability

No bio available.

• Cell Line Development

Dr. Moritz von Stosch is a thought leader in the area of hybrid modeling for bioprocess development and manufacturing. He is the co-author of more than 40 scientific publications, including the book "Hybrid Modelling in Process Industries." He is the Chief Innovation Officer at DataHow AG, developing novel approaches for accelerated process development and Managing Director of DataHow LDA. Prior to joining DataHow, Moritz led the Process Systems Biology & Engineering Centre of Excellence at GSK Vaccines, for which he received an Innovation Performance and Trust award and was nominated a change catalyst. He lectured at Newcastle University (England), holds a PhD in Biochemical Engineering from University of Porto (Portugal), and received a Dipl.Ing. in Chemical Engineering from RWTH Aachen University (Germany).

• Cell Culture and Bioproduction