Cambridge Healthtech Institute 第1回

Continuous Processing for Biopharmaceuticals

( 生物学的医薬品の連続処理 )

連続処理にまつわる現実的な課題の克服

2018年3月20-21日 | Sheraton Lisboa Hotel & Spa | ポルトガル、リスボン

理論上、連続処理は製造コストの低減と効率の向上を実現する最良の手段とされていますが、フェドバッチ培養から連続処理へと移行する際には、各種の現実的な課題に対処する必要があります。また、未解決の技術的な課題、企業がプロセスを制御し、安定性を確保するための方策、後の段階で成果をあげるために企業がリソースと投資を集中させるべき領域などについても考えておかなければなりません。

生物学的医薬品のための連続処理技術をテーマにしたこのカンファレンスプログラムでは、生物医薬品製造の分野で連続処理技術を開発、統合、導入するうえでの現実的な課題にスポットライトを当て、国際規制を踏まえながら、かん流から精製までのプロセスの開発、プロセス制御、堅牢性とモニタリング、ウイルス安全性、コスト分析、商業化に向けた生産拡大などのトピックについて議論します。


Final Agenda

3月19日 (月)

13:00 - 16:00 Recommended Dinner Short Course*

SC2: Continuous Processing Masterclass

The manufacture of biopharmaceuticals using semi- or fully continuous processes has the potential to improve product quality and increase the productivity of biomanufacturing facilities. This Short Course details the principles and practical challenges of implementing a continuous process strategy. Using examples and shared experiences, the course covers continuous processing definitions and drivers, technologies and processes, process development and control, and quality considerations.

Instructor: Margit Holzer, PhD, Owner, Ulysse Consult

* Separate registration required.

3月20日 (火)

7:00 Registration and Morning Coffee

かん流から精製までをカバーする連続プロセスの開発

8:25 Chairperson's Opening Remarks

Alois Jungbauer, PhD, Professor, Institute of Biotechnology, University of Natural Resources and Life Sciences


KEYNOTE PRESENTATION:

8:30 Continuous Processing for Vaccine Manufacturing - Challenges and Opportunities

Yan-Ping Yang, PhD, Head of Bioprocess Research & Development, North America, Sanofi Pasteur

Over the last decade there have been significant investments in continuous manufacturing in the pharmaceutical industry, as it holds great promise to lead the reduction of process steps, smaller footprint, higher product quality, and better pharmaceuticals for patients. While it's still in its early stage, the vaccine industry has embraced this concept and is ready to explore the full advantages associated with this approach. This presentation explores the challenges and opportunities to make continuous vaccine manufacturing a reality.

9:00 Continuous Manufacturing and the Challenges to Translate Processes from Lab-Scale to GMP Pilot Scale

Daniel Fleischanderl, PhD, Manager, Process Development, Shire

9:30 High Cell Density Cryopreservation Media for Perfusion Processes

Jochen_SieckJochen B. Sieck, PhD, Lab Head, Cell Culture Media R&D, Process Solutions R&D, Merck KGaA

For decades, batch-based processes dominated PD and manufacturing. But the market is changing, due to cost pressures, lower volume indications, and new drug formats and modalities. This requires more intensified and cost-effective processes, and more flexibility in manufacturing. We will present data how optimized cell culture media for perfusion allow for higher productivity, and high cell density cryopreservation can dramatically increase the flexibility of biopharma manufacturing.

10:00 Grand Opening Coffee Break in the Exhibit Hall with Poster Viewing

10:45 End-to-End Continuous Integrated Manufacturing of Therapeutic Proteins

Moritz_WolfMoritz Wolf, Researcher, The Morbidelli Group, ETH Zurich

Continuous manufacturing of therapeutic proteins describes a novel paradigm in the production of biopharmaceuticals resulting in improved volumetric productivity and product quality. These advantages are considered to alleviate regulatory issues and increased the interest in the integration of continuous unit operations. This study evaluates the performance of mammalian cell perfusion processes as part of an end-to-end integrated production stream and compares product quality in continuous integrated and batch production units.

11:15 Perfusion Strategies for Glycoproteins

Vicky_GoralczykVicky Goralczyk, PhD, Scientist USP, Glycotope GmbH

Difficult to express proteins pose certain challenges to established mammalian production systems. We propose tackling these challenges by implementing continuous processing and choosing a suitable cell line. Supporting case study data from clone and upstream perfusion development will be presented for challenging proteins such as a non-antibody glycoprotein or a rare antibody format protein.

11:45 Sponsored Presentation (Opportunity Available)

 

12:15 Luncheon Presentation: Development of a New Antibody-Drug Conjugate Diafiltration Process and Use of a Novel TFF Capsule

Eric Lacoste, Head, ADC Process Development Team, Bio-Organic, Sanofi

The generic ADC process is composed of at least three steps: chemical reactions in aqueous buffer (including some organic solvent); purification and formulation steps. This presentation will highlight TFF case studies during ADC purification process development within Sanofi, and will provide preliminary results using a novel single-use TFF capsule from Merck KGaA, Darmstadt, Germany. This new device is designed to replace standard TFF cassettes, providing the same level of performance while offering improved process containment.

12:45 Session Break

13:30 Chairperson's Remarks

Margit Holzer, PhD, Scientific Director, Ulysse-Consult

13:35 Deposit Formation Control on Membrane Surfaces in Up- and Downstream Continuous Processing

Ulrich_KulozikUlrich Kulozik, PhD, Chair, Food and Bioprocess Engineering, Technical University of Munich

Despite crossflow conditions retained material forms deposits on membranes surfaces, thus greatly impairing flux and transmission significantly. Continuous bioprocesses are therefore not under control. This presentation describes new methods for deposition control using novel membrane module concepts, including dynamic membranes, alternating and pulsed flow, gradient membranes and uniform transmembrane pressure mode. Cell retention in continuous lactic acid fermentation and fractionation of complex colloidal systems are used as examples.

14:05 Continuous Downstream Strategies for Future Processes

Gorazd_HribarGorazd Hribar, PhD, Project Manager nextBioPharmDSP; Scientist, DSP Development, Lek, A Novartis Company

The aim of the talk is to present current manufacturing strategies of biologics and approaches, which are being evaluated within the nextBioPharmDSP project, next-generation biopharmaceutical downstream process, where the main focus is to develop fully integrated and continuous approach for purification of monoclonal antibodies. The specific topics on which the focus will be are different approaches for primary separation, continuous chromatography, several flow-through options for polishing steps and advanced analytical tools, which will enable in-line detection of quality.

14:35 Residence Time Distribution Process Monitoring, Control of Continuous Downstream Processing

Alois_JungbauerAlois Jungbauer, PhD, Professor, Institute of Biotechnology, University of Natural Resources and Life Sciences

In continuous biomanufacturing series unit operations are interconnected, often in batch under equilibrium conditions. Here an example is shown where a much wider operation range can be used compared to batch wise operation. It will be elaborated how the residence time distribution of an entire process chain influences the start up and shut down and how residence time distribution in the reactor will impart process control.

15:05 Refreshment Break in the Exhibit Hall with Poster Viewing

15:45 Improving Purification of Next-Generation Vaccines with Multicolumn Chromatography

Ricardo_SilvaRicardo Jorge Sousa da Silva, PhD, Researcher, iBET

Novel biopharmaceutical products, such as vaccines and viral vectors, are a challenging task for downstream processing. Alternative purification strategies such as continuous chromatography, are regarded nowadays as enabling technologies to overcome the capacity bottleneck in biomanufacturing. The current talk will focus on the steps followed towards the development of multi-column chromatographic systems aimed at the purification of gene therapy vectors and enveloped virus-like particles for vaccine applications.

16:15 Novel Single-Column Simulated Moving-Bed Chromatography for Quasi-Continuous Biopurification

Abimaelle_ChiberioAbimaelle Chiberio, PhD Student, Universidade Nova de Lisboa

This system is a more compact, less expensive, and simpler-to-operate alternative to the SMB. The newly developed platform shares the benefits of SMB chromatography in that it not only gives significantly higher yields of purer product, but also enables processing more feed and thereby increasing the overall throughput. The single-column chromatograph can be easily integrated into the existing downstream processing platforms of complex biopharmaceuticals.

16:45 Breakout Discussion Groups

This session provides the opportunity to discuss a focused topic with peers from around the world in an open, collegial setting. Select from the list of topics available and join the moderated discussion to share ideas, gain insights, establish collaborations or commiserate about persistent challenges. Then continue the discussion as you head into the lively exhibit hall for information about the latest technologies.

17:30 Welcome Reception in the Exhibit Hall with Poster Viewing

18:30 End of Day

3月21日 (水)

8:00 Registration and Morning Coffee

プロセスの設計、制御、データ管理

8:25 Chairperson's Opening Remarks

Margit Holzer, PhD, Scientific Director, Ulysse-Consult

8:30 Continuous Chromatography Process Design Considerations and Validation Strategies

Margit_HolzerMargit Holzer, PhD, Scientific Director, Ulysse-Consult

Switching from batch to continuous processing requires specific development. Main steps of this development work allowing the definition of design spaces will be described in detail. Based on the resulting measurements for a specific design space, process-monitoring and control strategies and requirements for the equipment will be highlighted. Furthermore, additional studies and assessments needed for process validation will be presented. The mAb Protein A capture step will serve as example.

9:00 Data Management as a Key to Process Understanding and Development Efficiency for Continuous Processing

Martin_MayerMartin Mayer, PhD, Director, evon GmbH, Austria

Bioprocess development and characterization rely on reasonable DoEs, meaningful on- and offline process monitoring concepts and methods for automated data handling, analysis and interpretation including data integrity issues. Although GMP criteria do not fully apply within all steps of R&D, one obstacle preventing the implementation of these key issues into bioprocess development and operation is the lack of software tools designed for fully automated management of complex bioprocess data sets.

9:30 Machine Learning for Bioprocessing Using Raman Spectroscopy

Alessandro_ButteAlessandro Butte, PhD, Lecturer, ETH Zurich

Using examples, this presentation will examine statistical methods and multivariate decision tools, machine learning and hybrid models, process control using online monitoring and supervisory control and quality prediction.

 

10:00 High-Throughput, Low Volume Subvisible Particle Screening

Bernardo Cordovez, President, Halo Labs

Halo labs will present a subvisible particle screening tool, the HORIZON, with detailed explanation of its Backgrounded Membrane Imaging (BMI) technology. A comparative analysis between HORIZON and flow imaging will be presented and key performance indicators including sample volume, throughput, dynamic range, instrument repeatability will be evaluated.

10:15 Sponsored Presentation (Opportunity Available)  

10:30 Coffee Break in the Exhibit Hall with Poster Viewing

全体基調セッション

11:15 Chairperson's Remarks

Manuel Carrondo, PhD, Professor of Chemical and Biochemical Engineering, FCT-UNL, Vice President, IBET

11:20 Integrated Drug Substance-Drug Product Development for the Next Generation of Biologics

Hitto Kaufmann, PhD, Global Head, BioPharmaceutics Development & Platform Innovation, Global R&D, Sanofi-Aventis

The rise of next generation biologics brings with it new challenges. This presentation will examine how bioprocessing departments are adapting to evolving and diverse biological pipelines and the role of innovation as a key driver to deliver superior medicines to patients. The convergence of CMC technologies will also be examined using examples from Sanofi where relevant.

11:50 Next-Generation Processes, Technologies and Operations

Eliana Clark, PhD, Vice President, International Manufacturing Operations, Biogen

A critical step in meeting the demand of biologic production worldwide involves implementing disruptive manufacturing technologies, processes and capabilities. This talk will evaluate Biogen's new manufacturing site in Switzerland, due to go online in 2019, including the new processes, operational models and technologies being adopted to drive value through innovation and deliver new medicines in areas such as Alzheimer's.

12:20 End of Conference


* 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。