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)

高度な連続処理は、企業がコストを最小限に抑えながら生産性と施設の利用率を向上させるための効率的な方法です。しかし、現実的な考慮事項、技術格差、産業界によるセンサー・データ・デジタル化の向上による大規模なプロセス制御の改善については、どのようにすればよいのでしょうか?Cambridge Healthtech Instituteの初開催「高度な連続処理」会議では、上流工程から下流工程の連続処理における開発、統合、実装の現実的な課題に焦点を当てています。主なトピックには、プロセスの強化、パーフュージョンから精製までの連続プロセス開発、プロセス制御、堅牢性と監視、ウイルスの安全性、コスト分析、商業化に向けた生産増強などが含まれ、すべて国際規制に準拠しています。

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

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

12:30 Designing Purification Strategies for Bispecific Antibodies Based on Molecule Design

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

14:00

Chairperson's Remarks

Stefan R. Schmidt, MBA, PhD, COO & Head, Operations, BioAtrium AG

14:05 KEYNOTE PRESENTATION:

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.

14:35

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.

15:05

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.

15:35 Talk Title to be Announced

Speaker to be Announced

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

16:40 FEATURED PRESENTATION:

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.

17:10

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.

17:40 Talk Title to be Announced

Sebastian Thurmann, PhD, Product Management, Tosoh Bioscience

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

08:25

Chairperson's Remarks

Andrew Sinclair, President & Founder, BioPharm Services Ltd., United Kingdom

08:30

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.

09:00

Sustainable Metrics for Biopharmaceutical Production

Felix Dieringer, PhD Student, Responsible Process Design, Takeda

This presentation examines recent developments of green chemistry and sustainability metrics with a focus on the biopharmaceutical industry.

09:30

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.


10:00 Talk Title to be Announced

Jack Cordrey, PhD, Bioprocess Applications Specialist, Separations & Purification Sciences Division, 3M

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

11:00

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.

11:30

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.

12:00

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.

12:30 Talk Title to be Announced

Pinar Carkci, Product Manager, Asahi Kasei Bioprocess Europe

Networking Lunch (Sponsor Opportunity Available)13:00

PROCESS CONTROL AND MODELLING
プロセス制御とモデリング

13:45

Chairperson's Remarks

Michael Sokolov, PhD, Co-Founder and COO, DataHow AG, Lecturer, ETH Zurich

13:50

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.

14:20

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).

14:50

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

* 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