Cambridge Healthtech Instituteの第5回年次会議

Cell Therapy Manufacturing
(細胞治療薬製造)

スケールアップ戦略の最適化と商業的成功への布石

2023年3月14 - 15日、CET(中部欧州標準時)

Cambridge Healthtech Instituteの第5回「細胞治療薬製造」年次会議には産学官の第一線の専門家が集まり、自己および同種細胞療法のスケールアップと製造における実用的な課題を克服することを目的として議論を行います。この会議では、CAR Ts、NK細胞、TCR、TIL、MSC、IPSC、ガンマ・デルタT細胞などの自己および同種細胞製造プラットフォームに関する詳細なケーススタディが提供される予定です。

3月14日(火)

Registration and Morning Coffee07:00

ADVANCED MANUFACTURING PROCESSES
先端的な製造プロセス

08:25

Chairperson's Remarks

Sanjin Zvonic, PhD, Vice President, Business Development & Practice Expert, Dark Horse Consulting

08:30

The Challenges of Developing Bespoke Technologies to Close and Automate Complex Cell Therapy Manufacturing Processes

Toby Proctor, EngD, Head of Manufacturing Science and Technology, Achilles Therapeutics

09:00

Manufacturing Enhancements with a Focus on Robustness, Quality, and Speed of TCR T Product Release

Ali Mohamed, PhD, Vice President, CMC, Immatics US, Inc.

IMA203 & IMA203CD8 are Immatics’ TCR T product candidate(s) using a PRAME-specific TCR with or without a CD8 co-receptor. Manufacturing improvements implemented enhance key features of the cell product. Continuous enhancements are in progress in preparation of later-stage clinical trials.


09:30 Talk Title to be Announced

Speaker to be Announced

Presentation to be Announced09:45

Grand Opening Coffee Break in the Exhibit Hall with Poster Viewing10:00

10:45

A Consortium Investigation for the Implementation of PATs for Immunotherapy Manufacturing

John Churchwell, PhD, Associate Lead Scientist, Cell & Gene Therapy Catapult

There are longstanding challenges in the commercialisation of ATMPs that can be addressed by the implementation of process analytical technologies (PATs). Cell and Gene Therapy Catapult (CGTC) has led a consortium project with 23 collaborators to investigate the application of PAT and advanced analytics for a T-Cell immunotherapy process. We will describe results from the online, in-line and at-line PATs employed in the study discussing the different applications and implementations.

11:15

Integrated Manufacturing for Autologous and Allogenic Cell Therapeutics

Rolf Werner, PhD, Professor, Industrial Biotechnology, University of Tuebingen

Gene and cell therapies are gaining more and more interest in personalized precision medicine. From a manufacturing perspective, cell therapies are fairly demanding, requiring chemical gene synthesis, plasmid DNA fermentation and purification, along with viral vector design and production via mammalian cell cultures, isolation of human T cells from the patient or allogenic T cells, propagation of the T cells and transfection with the viral vector carrying the gene of interest for a ligand on the T cell surface targeting the T cell to the tumor cell to express their cytotoxic effect. Or coupling monoclonal antibodies to the surface of the T cell to target the tumor cell. An end-to-end supplier for all required manufacturing technologies is advisable and will facilitate the process chain.

11:45 PANEL DISCUSSION:

Advanced Manufacturing Processes

PANEL MODERATOR:

Sanjin Zvonic, PhD, Vice President, Business Development & Practice Expert, Dark Horse Consulting

PANELISTS:

Toby Proctor, EngD, Head of Manufacturing Science and Technology, Achilles Therapeutics

Ali Mohamed, PhD, Vice President, CMC, Immatics US, Inc.

John Churchwell, PhD, Associate Lead Scientist, Cell & Gene Therapy Catapult

Rolf Werner, PhD, Professor, Industrial Biotechnology, University of Tuebingen

12:15 Talk Title to be Announced

Alexander Nikolay, PhD, Product Manager, Clinical Marketing, Miltenyi Biotec B.V. & Co. KG

12:30 Talk Title to be Announced

Speaker to be Announced

Networking Lunch (Sponsor Opportunity Available)12:45

ADVANCED MANUFACTURING PROCESSES (CONT.)
先端的な製造プロセス(続き)

13:45

Chairperson's Remarks

Michael Leek, PhD, Executive Chairman & Founder, TC BioPharm Ltd.

13:50 KEYNOTE PRESENTATION:

Decentralized Manufacturing and POCare Processing Platform

Vered Caplan, CEO, Orgenesis, Inc.

A roadmap to enabling cell and gene therapies (CGTs) in an affordable and accessible format at the point of care. The Orgenesis Point-of-Care (POCare) Platform enables a globally harmonized pathway for CGTs to reach large numbers of patients at the point of care at reduced costs through a data centric approach supporting scalable, and decentralized production. OMPULs (Orgenesis Mobile Production Units and Labs) are autonomous production units allowing rapid global deployment. 

14:20

Challenges to Commercialisation of Allogeneic Cell Therapies

Michael Leek, PhD, Executive Chairman & Founder, TC BioPharm Ltd.

Cell therapy has long been regarded as a potential therapeutic panacea, having potential to restore structure and function of damaged and diseased tissue and whole organ systems. Many observers correctly regard cell therapies as an exciting new area of medicine, as demonstrated by some of the CAR-T data recently generated in cancer patients. Despite this encouraging clinical data, many of the challenges faced in the 1980’s when companies like ATS and Organogenesis were developing the first cell-based products still exist. We are still grappling with logistics of shipping such products from clean room to clinic, regulatory uncertainty from region-to-region, donor-to-donor variation of allogeneic products, and high cost of goods.

14:50 Talk Title to be Announced

Speaker to be Announced

Refreshment Break in the Exhibit Hall with Poster Viewing15:20

15:40

End-to-End Automation Platform for the Manufacture of Complex Organoid-Based Implants

Ioannis Papantoniou, PhD, Associate Professor, Skeletal Biology & Engineering Research Center, Catholic University Leuven

Organoid-based implant manufacturing may enable the production of complex 3D ATMP implants able to revolutionise defect regeneration and restore organ function. Engineering such complex ATMPs requires manufacturing technologies that can provide a robust backbone for phenotypic changes but also for increase in size. In this presentation a novel integrated and fully automated biomanufacturing platform will be showcased allowing the automated transition from single cells to organoids and finally to organoid-based 3D implants.

16:10

Biological Raw Material Sourcing for an Early Stage ATMP and Considerations for Late Stage Clinical Development

Sidonie Karlsson, Head of Manufacturing, Amniotics

Amniotics has developed a MSC cell therapy for treatment of inflammatory lung diseases, currently tested in a Phase I clinical trial. The process uses multiple raw materials of biological origin, e.g., as source material (MSCs from amniotic fluid), sorting antibody, culture medium, detachment enzyme. Quality requirements, suitability for manufacturing of Phase I clinical material and supply issues are discussed here, as well as regulatory aspects and considerations for further development.

16:40

A Translational Services Business Model on the Grounds of Public Cell and Tissue Banking

Joaquim Vives, PhD, Head of Production, Advanced Therapies, Banc de Sang i Teixits

Cell and tissue banks are establishments adhering to strict quality management standards and regulations, and we advocate its prominent role to enhance the value of donated Substances of Human Origin in innovative Advanced Therapy Medicinal Products. To achieve this, we have created a platform for collaboration with academic and industrial developers, supporting a range of activities from bioprocess design and Good Manufacturing Practice validation, to early phase I/II clinical trials.

Interactive Discussions17:10

Interactive Discussions are informal, moderated discussions, allowing participants to exchange ideas and experiences and develop future collaborations around a focused topic. Each discussion will be led by a facilitator who keeps the discussion on track and the group engaged. For in-person events, the facilitator will lead from the front of the room while attendees remain seated. To get the most out of this format, please come prepared to share examples from your work, be a part of a collective, problem-solving session, and participate in active idea sharing. Please visit the Interactive Discussion page on the conference website for a complete listing of topics and descriptions.

Welcome Reception in the Exhibit Hall with Poster Viewing17:40

Close of Day18:45

3月15日(水)

Registration and Morning Coffee08:00

IMPACT OF BIG PHARMA
ビッグファーマの影響

08:25

Chairperson's Remarks

Michael Delahaye, Director, Team Leader Cell Therapy Bioprocessing, AstraZeneca

08:30 FEATURED PRESENTATION:

Harnessing the Capabilities of Big Pharma to Drive Cell Therapy

Michael Delahaye, Director, Team Leader Cell Therapy Bioprocessing, AstraZeneca

LARGE-SCALE WORKFLOWS AND CRYOPRESERVATION
大規模ワークフローと凍結保存

09:00

Development of an Allogenic Mesothelin CAR T Cell Therapy Production Process with a Representative Scale-down Model

Jean-Charles Epinat, PhD, Director, Process Development, Cellectis

CAR T cell therapy success in solid tumors has been limited due to the lack of tumor-specific antigens, to tumor heterogeneity, and to the immuno-inhibitory nature of the tumor microenvironment. To address these challenges, we engineered CAR T cells that use the tumor-specific mesothelin antigen as a discriminatory target and have enhanced therapeutic properties provided by multiple attributes. Its manufacturing method has been designed using a representative small-scale model that led to a new large-scale workflow.

09:30

Strategies for Cryopreservation and Banking of iPS Cells and Their Derivatives

Julia Neubauer, Head of Department, Cryo & Stem Cell Technology, Fraunhofer Institute, IBMT

Cryopreservation of iPS cells in large numbers or of functional, differentiated cells is also crucial for later success in therapy or other applications. Therefore, to meet the increasing demand in downstream applications, we have established robust, scalable cryopreservation protocols for iPS cells and several derivatives. This includes the use of large volume cryobags, ready-to-use formats and cryopreservation of tissue engineered products.

Sponsored Presentation (Opportunity Available)10:00

Coffee Break in the Exhibit Hall with Poster Viewing10:30

PLENARY SESSION: EMERGING MODALITIES, PLATFORMS, AND TECHNOLOGIES - FROM mRNA TO PROTEINS
基調講演:新興のモダリティ、プラットフォーム、技術 - mRNAからタンパク質へ

11:15

Chairperson's Opening Remarks

Margit Holzer, PhD, Owner, Ulysse Consult

11:20 PLENARY PRESENTATION:

Overcoming CMC and Supply Chain Challenges for mRNA Technologies

Gregory Troiano, Chief Manufacturing Officer, mRNA Center of Excellence, sanofi

Thanks to the rapid development of mRNA vaccines for COVID-19, the industry now has the momentum and resources to overcome many of the early CMC challenges and realize its enormous potential. This presentation will discuss the strategies in place to overcome CMC and supply chain challenges for mRNA technologies already and future innovations primed to take it to the next level.

11:50 PLENARY PRESENTATION:

Affinity Proteins for Biotechnological and Medical Purposes

Sophia Hober, PhD, Professor, School of Biotechnology, KTH Royal Institute of Technology

Affinity proteins are crucial for life, for building structures, performing reactions, and for signaling purposes. In life sciences and medicine, affinity proteins are used to generate knowledge, but also for diagnostic and therapeutic purposes. This talk will cover how antibodies and small affinity molecules can be used to map the human proteome, develop diagnostic tools for in vivo visualization as well as efficiently purify therapeutics based on antibodies.

Transition to Sessions12:20

Sponsored Presentation (Sponsor Opportunity Available)12:30

Networking Lunch (Sponsor Opportunity Available)13:00

Close of Cell Therapy Manufacturing Conference14:00

* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。

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Prelim Agenda Now Available

3月14 - 15日

CELL CULTURE AND BIOPRODUCTION

ADVANCES IN RECOVERY & PURIFICATION

GENE THERAPY CMC AND ANALYTICS

CELL THERAPY MANUFACTURING

ANALYTICS AND CHARACTERIZATION

3月14 - 15日

CELL LINE DEVELOPMENT

INTENSIFIED & CONTINUOUS PROCESSING

GENE THERAPY MANUFACTURING

CELL THERAPY CMC AND ANALYTICS

FORMULATION AND STABILITY