Cambridge Healthtech Instituteの第6回年次会議
Intensified and Continuous Processing
(高度な連続処理)
プロセスの強化、監視、制御の向上
2023年3月15 - 16日、CET(中部欧州標準時)
3月15日(水)
Registration Open10:30
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
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.
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

Jakob Liderfelt, Global Product Manager - Antibody Polishing, Cytiva
Developing purification protocols for multispecific antibodies present extra challenges compared to conventional therapeutic monoclonal antibodies (mAbs). Strategies for efficient capture and polishing are discussed already in antibody engineering. Strategies include available resins and methods and need to give sufficient separation of product and process related impurities. This presentation covers different aspects of designing a GMP purification process for bispecific antibodies.
Networking Lunch (Sponsor Opportunity Available)13:00
END-TO-END CONTINUOUS PROCESSING
エンドツーエンド連続処理
End-to-End Integrated and Continuous Monoclonal Antibody Manufacturing
Richard D. Braatz, PhD, Edwin R. Gilliland Professor, Chemical Engineering, Massachusetts Institute of Technology
A fully instrumented testbed is described for the end-to-end, integrated, and continuous manufacturing of monoclonal antibodies. The testbed consists of parallel bioreactors, simulated moving bed chromatography systems for capture and polishing, bespoke viral inactivation, and a MAST auto-sampling system. Experimental results are compared with a digital twin for continuous runs lasting 30 to 60 days each, which include variations in metabolites and glycosylation profiles in designed experiments. The increased consistency in the glycosylation profile of the monoclonal antibodies being produced is quantified when going from batch to semi-batch to perfusion mode, and when moving from startup to quasi-steady conditions.
Smart Tools for High Cell Density Perfusion Culture Process
Veronique Chotteau, Associate Professor, Director of AdBIOPRO, Centre for Advanced Bioproduction by Continuous Processing, Industrial Biotechnology, KTH Royal Institute of Technology
We have created an approach for optimization of mammalian cell perfusion process by smart substrate targeted feeding, providing high cell growth, viability, productivity, and low byproducts. This work is supported by scale-down bioreactors fully operated in perfusion: stirred tank bioreactor of 200 mL and ERBI bioreactor of 2 mL. For the substrate optimization (e.g., glucose, amino acids) it leans on design of experiment or digital twin approaches.
Intensified and Continuous Processing
Gerald Striedner, PhD, University Professor, Biotechnology, University of Natural Resources and Life Sciences Vienna (BOKU), Austria
Genome-integrated, as well as growth-decoupled E. coli expression systems, enable continuous protein production. Efficient implementation requires suitable process strategies for cultivation and product recovery and purification. The presentation will show two case studies inclusive of an economic evaluation with standard fed-batch as benchmark.
Refreshment Break in the Exhibit Hall with Poster Viewing16:05
COMMERCIAL-SCALE CONTINUOUS PROCESSING
商業スケールの連続処理
Highly Flexible Future-Proof Bioprocess Facility - Understanding Shift in Requirements from Development to Commercialization for Continuous Manufacturing
Lara Fernandez-Cerezo, PhD, Associate Principal Scientist, Merck
Standard batch monoclonal antibody biologics manufacturing processes are costly and time-consuming. A switch to intensified continuous processing enables much higher productivity. Lessons learned from initial continuous manufacturing clinical productions at Merck have been directly leveraged and used to project process, automation, and analytical requirements for next-generation commercial facilities. Facility design strategies including modularity, flexibility, ‘lights-out operation,' and reduced scale have become key concepts for future highly automated and intensified processes.
Intensification Strategies: Multiple Dimensions at Different Stages for Higher-Throughput
Stefan R. Schmidt, MBA, PhD, COO & Head, Operations, BioAtrium AG
Processes can be intensified at all scales and all dimensions and are not limited to commercial production only. However, that requires implementing approaches to achieve “more, with less effort, faster” already at the beginning. This presentation gives a comprehensive overview of strategies how to integrate process intensification through the whole product life cycle. The opportunities from early development to continuous process improvements will be summarized in this talk.
Close of Day18:15
3月16日(木)
Registration and Morning Coffee08:00
SUSTAINABLE APPROACHES TO BIOPROCESSING
バイオプロセシングに対する持続可能なアプローチ
Predicting Performance and Sustainability Based on Process Intensification and Geography
Andrew Sinclair, President & Founder, BioPharm Services Ltd., United Kingdom
The drive to net zero and a more sustainable future requires an understanding of the impact of Process Intensification options in terms of sustainability and business efficiency. The latest process models evaluate facility efficiency (doses per unit volume of cleanroom), PMI, and total energy efficiency. Pre-release versions were used by process intensification team in NIIMBL to support sustainability assessments. In this talk, comparisons are made between standard fed-batch processes and intensified process options that include perfusion and continuous downstream operations and considers the impact of facility locations.
Chelation Technology, a Simple and Effective Solution to Remove Copper from CSL's Human Albumin Product
Robin Das Gupta, PhD, Team Lead, PPD Process Development, CSL Behring
CSL Behring manufactures albumin in various concentrations that serve different medical needs. Interestingly, higher concentrations of albumin showed dark sediments, with copper sulphide (CuS) being the main component. Studies determined a Quality Target for copper (= 0.2mg/kg), which significantly delays formation of sediments. One method identified to remove CuS is the chelation and sequestration of metal ions by chelating agents. Here, a strategy using EDTA and a new chelator named EDDS was developed. For both chelators, low pH positively impacted proteolytic activity and improved binding capacity. Additionally, accelerated stability studies demonstrated that these chelators delayed the dark sediment formation significantly.
Coffee Break in the Exhibit Hall with Poster Viewing10:30
SMART BIOPROCESSING
スマートバイオプロセシング
The Role of Digitalization in Continuous Processing of Therapeutic Proteins
Massimo Morbidelli, PhD, Professor, Department of Chemistry, Materials and Chemical Engineering, Politecnico di Milano, President, DataHow AG
Mattia Sponchioni, PhD, Assistant Professor, Department of Chemistry, Materials and Chemical Engineering, Politecnico di Milano
Biopharmaceuticals have experienced a rapid growth in the market. To sustain this growth while preserving the product quality, the Quality-by-Design (QbD) initiative was imposed, which has process intensification as a main pillar. This can be achieved through integrated continuous biomanufacturing. Process integration and continuous operations are valuable strategies toward consistent product quality attributes and high throughput. However, to express their full potential, digitalization stands as the keystone, allowing to reduce the time-to-market and costs, to fulfill the QbD guidelines, and to introduce a model-based process control. The opportunities and challenges of digitalization are then presented in the framework of biomanufacturing.
Implementing the Lab of the Future - Pain or Gain?
Sandra Krause, Lab Engineer, Biodevelopment Microbial Platform, sanofi
Digital Transformation is one of the keywords in the beginning of the 21st century. Companies, including biotech and pharma, now push forward to keep pace with customer needs and competitors. Here, we describe the pitfalls, pains, and gains in preparing, transforming, and executing digitalization in our labs, as part of sanofi’s global digital transformation.
Digital Transformation in BioPharma Manufacturing: Current Business, Organizational, and Technological Challenges-- and Opportunities
Michael Sokolov, PhD, Co-Founder and COO, DataHow AG, Lecturer, ETH Zurich
Pharma manufacturing is still mostly focusing on the exploration phase of digital technology. The major goal of this presentation is to identify major drivers and challenges for digitalization and digital transformation in pharma manufacturing. Three main perspectives, namely technology, organization, and culture, as well as management and business strategy, will be highlighted. The results are based on extensive collaboration with several tens of pharma, biotech, and CDMO companies.
Networking Lunch (Sponsor Opportunity Available)13:00
PROCESS CONTROL AND MODELLING
プロセス制御とモデリング
Modeling & Simulation as One Key Element in Next-Generation CMC
Johannes Scheiblauer, Fellow, Automation & Control, Innovation & Technology Sciences, Pharmaceutical Sciences, R&D, Takeda
Several enabling technologies change the way we do pharmaceutical development: automation and digitalization, modeling and simulation. But especially the latter are not silver bullets, and it is important to have a closer look: why and when one might use them, which factors support a successful and sustainable implementation, and what it means for an organization to embrace these new ways of work.
Continuous Biologics Manufacturing at CPI: Past, Present, and Future
Daniel Myatt, PhD, Senior Analytical Scientist, Biologics, Center for Process Innovation Ltd.
The Centre for Process Innovation (CPI) is part of the UK High Value Manufacturing Catapult (HVMC). CPI has been, and is currently, involved in several continuous biologics manufacturing projects. Process analytical technology (PAT) is becoming increasingly important in biologics manufacturing. In this talk, I will discuss previous and current projects involving continuous manufacturing and the use of novel process analytical technologies (PATs).
Benefits of Microbial Continuous Processing
Julian Kopp, PhD, Postdoc Researcher, Chemical & Environmental & Biological Engineering, Vienna University of Technology
State-of-the-art recombinant protein production with microbials is conducted in fed-batch cultivation. Switching to continuous processing would impose small-footprint manufacturing and increase the space-time yield compared to fed-batch processing. Still, industry and research struggle in achieving long-term microbial cultivations with stable productivity. Within this presentation, I will address reasons for fluctuating productivity in continuous processes, and discuss opportunities and how to overcome these challenges.
Close of Summit15:20
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