Cambridge Healthtech Instituteの第6回年次会議

Advances in Recovery and Purification
(回収・精製の進歩)

DSPの最適化、コスト削減、開発の加速

2023年3月14 - 15日、CET(中部欧州標準時)

Cambridge Healthtech Instituteの第6回「回収・精製の進歩」年次会議では、産業界と学界が一堂に会し、バイオ医薬品(mAb、非mAb)の持続可能な捕捉、回収、精製の最新動向について議論します。また、アフィニティークロマトグラフィー、清澄化、深層ろ過、自動化、HTPD、新しい膜、凝集における次世代の技術と戦略や、フラグメント、二重特異性、ADC、遺伝子治療薬、mRNA医薬、ワクチンなどの新興モダリティのDSP戦略におけるデータ主導のケーススタディも紹介します。

3月14日(火)

Registration and Morning Coffee07:00

PLATFORMING COMPLEX BIOLOGICS
複雑なバイオ医薬品のプラットフォーム

08:25

Chairperson's Remarks

Margit Holzer, PhD, Owner, Ulysse Consult

08:30 KEYNOTE PRESENTATION

Precision Medicine for Cancer Treatment Leveraging Industrialized, Robust and Simple Bispecific Antibody Platform: Learnings from a 10-Year Journey

James Reilly, Associate Director, Regeneron Pharmaceuticals, Inc.

Cancer is a leading cause of death worldwide, accounting for almost 10 million deaths in 2020. Regeneron has a bispecific immuno-oncology platform technology, where the patient's immune system is activated to recognize and eliminate cancer cells, that has shown substantial potential across cancer types. This presentation outlines key learnings from a 10-year journey whereby these bispecific antibodies have become readily available industrialized therapeutics amenable to meeting a global demand.

09:00 FEATURED PRESENTATION

Implementation of Purification Platform for Nanobody Molecules - Lessons Learned

Kaihui Hu He, PhD, Laboratory Head, Microbial Platform DSP, Global CMC Development, Sanofi

Nanobody molecules, a type of single-domain antibody, are an attractive drug class thanks to their therapeutic versatility and production advantages. In our Microbial Platform Downstream Processing team, Nanobody molecules from microbial fermentation extracts are handled by a classical multi-step process entailing Capture, Intermediate, Polishing Purification, and Ultrafiltration-Diafiltration steps. Tailored processes and adaptations have been made to reduce impurities and multimerizations to accommodate demands in clinical development.

09:30 Talk Title to be Announced

Speaker to be Announced

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

DOWNSTREAM PROCESSING FOR COMPLEX BIOLOGICS
複雑なバイオ医薬品の下流工程プロセス

10:45

Downstream Processing of DuoBody and HexaBody Antibody Formats

Rick Hibbert, PhD, Senior Director, Head of CMC Science and Technologies, Genmab BV

Genmab's DuoBody platform is a versatile technology for generating bispecific antibodies via a post-production exchange process. The HexaBody platform allows for the creation of potent therapeutics by promoting hexamer formation on the cell surface for enhanced complement-mediated cytotoxicity. These platforms are used to create next-generation antibody therapeutics. Case studies describe the downstream processing strategies that are utilized to control the process at research and manufacturing scale.

11:15

Development of a High-Throughput Purification Workflow within the Constraints of a Containment Facility

Daniel Melotte, PhD, Scientist II, Downstream Development, IPSEN Biopharm Ltd.

Developing commercial Upstream and Downstream processes for potent molecules can be highly challenging due to processes requiring containment facilities to isolate the product from the operator. Standard high-throughput screening platforms are not viable due to the limited space within these highly controlled containment facilities. This project aimed to configure and program an AKTA Pure to establish an automated method to process multiple bioreactor samples through multiple purifications and buffer conditioning steps in containment to enable better decision-making for Upstream development.

11:45

Real-Time Aggregate Detection during Cation Exchange Bind-and-Elute Chromatography for Optimised Pooling: A BioPhorum Proof-of-Concept Collaboration

Matthias Wiendahl, Principal Scientist, Biopharm API Support, Novo Nordisk AS

An industry-wide team consisting of 18 companies from pharmaceutical manufacturers and suppliers organised by BioPhorum is working on a proof of concept for controlling product collection during bind-and-elute cation exchange chromatography of monoclonal antibodies. The analytical technique of choice is real-time multi-angle light scattering (RT-MALS) which is used for aggregate monitoring. This talk will summarize the project setup, the challenges encountered and the experimental design developed by the team. Initial results from experiments performed will be also highlighted.

12:15 Talk Title to be Announced

Speaker to be Announced

Networking Lunch (Sponsor Opportunity Available)12:45

ADVANCING RECOVERY AND PURIFICATION
回収・精製の進歩

13:45

Chairperson's Remarks

David O’Connell, PhD, Lecturer in Biotherapeutics, School of Biomolecular & Biomedical Science, University College Dublin

13:50

Digital UF-DF-UF Twin: How to Successfully Design This Crucial Bioprocess Step

Maximilian Krippl, PhD, Head of DSP Modeling, Novasign GmbH

Ultra- and diafiltration is a critical step in virtually every bioprocess. Due to various membrane interactions, it can be difficult to fully recover the product which leads to low yields and higher overall process costs. By introducing controlled process variations, hybrid modeling helps to identify the best suited process conditions with few experiments. We present a UF-DF-UF model to predict and describe product and membrane specific filtration processes.

14:20

3D Visualization and Characterization of Chromatographic Packed Bed and Individual Bead Structure

Thomas F. Johnson, PhD, Senior Research Fellow, Biochemical Engineering, University College London

In this study, high resolution X-ray computed tomography is applied to visualise and characterise internal geometry of packed beds and individual beads made of agarose, cellulose and ceramics. Pixel sizes from 3 µm to 32 nm enabled resolution of detailed features to analyse properties including porosity and available surface area, with positional based analysis able to identify physical phenomena such as wall effects.

14:50 Talk Title to be Announced

Jessica Chow-Hubbertz, Lab Head DSP, Bioprocess Engineering, SANOFI

Refreshment Break in the Exhibit Hall with Poster Viewing15:20

IMPROVING RECOVERY AND PROCESS UNDERSTANDING
回収の向上とプロセスの理解

15:40

Development of Purification Procedures for Engineered 10kDa Scaffolds from a Novel Selection Platform

David O’Connell, PhD, Lecturer in Biotherapeutics, School of Biomolecular & Biomedical Science, University College Dublin

This talk describes two directions toward therapeutic developments: 1) the design and production of proprietary protein libraries based on a small and stable scaffold with a screening procedure that has identified specific binders against difficult-to-drug targets, and 2) approaches to (a) producing a candidate drug-protein at scale and (b) high-throughput production method development for candidates from selections for functional screening rounds are described using tagless, affinity tag-based, and twin IEX approaches.

16:10

Multi-Product Protein A Resin Reuse for Biopharmaceutical Products

Stanislas Helle, PhD, Postdoc Researcher, Chemical Sciences, University of Limerick

The overall purpose is to compare the performance of a resin reused to process a single product stream with the same mAb select Sure protein A resin type reused to process two product streams. The specific objectives of the project are to conduct a proof of concept study using protein A resin, 2 IgG product streams produced by a platform CHO cell lines and advanced analytical methodology using LC-MS. Here, we developed the experimental design to determine if the same yield and quality of product can be obtained compared to keeping the resin dedicated to the one product stream only.

16:40

CSL112 Process Characterization: A Modern Process Development Approach Implementing QbD Principles

Jonathan Eras, PhD, Senior Manager, Process Development R&D, CSL Behring

A modern process development approach implementing QbD principles will be presented which is very relevant to ensure process understanding

17:10 Talk Title to be Announced

Speaker to be Announced

Welcome Reception in the Exhibit Hall with Poster Viewing17:40

Close of Day18:45

3月15日(水)

Registration and Morning Coffee08:00

CONTINUOUS DOWNSTREAM PROCESSING
下流工程の連続処理

08:25

Chairperson's Remarks

Jose Paulo B. Mota, PhD, Professor, Chemical & Biochemical Engineering, University Nova de Lisboa

08:30

Cell-Tolerant Radial Affinity Chromatography

Michel H.M. Eppink, PhD, Senior Director, Downstream Processing, Byondis BV

Biopharmaceutical proteins (e.g. monoclonal antibodies) are important therapeutic medicines for different human diseases such as oncology. In this presentation, the USP bioreactor will be directly integrated into the DSP capture column so that the expressed monoclonal antibody can be directly purified on the capture step consisting of a disposable cell Tolerant Radial Affinity Chromatography (cTRAC) column and the cells efficiently removed as waste in closed disposable bags.

09:00

Recent Advances in Model-Based Design and Optimization of Downstream Processing of Biopharmaceuticals

Jose Paulo B. Mota, PhD, Professor, Chemical & Biochemical Engineering, University Nova de Lisboa

We discuss how continuous multicolumn chromatography for downstream processing of biopharmaceuticals can be designed for improved performance using model-based state-of-the-art optimisation tools. The aim is not only to maximize process throughput but also to explore the possibility of reducing solvent consumption, increasing product concentration, and, if possible, reducing the number of steps of the operating cycle. Concrete examples of the increased productivities and cost savings benefits of using optimised continuous multicolumn chromatography are given.

09:30

Latest Developments in Continuous Downstream Processing: Updates from CODOBIO

Raquel Aires-Barros, PhD, Professor, Bioengineering, Instituto Superior Tecnico

The CODOBIO consortium consists of nine industry partners, eight universities, one research organisation, a regulatory institution and a business consultancy, and has developed a research and training programme including relevant scientific/technical and transferable skills trainings. This presentation will review the cutting-edge science and future industrial applications of the findings.

10:00 SMART Cycling and Advances in Protein A Chromatography Resins

Mark Hicks, PhD, Applications Manager, Bioprocessing, Purolite

Jetting technology is a scalable continuous emulsification technology by which all Praesto® chromatography resins are produced. This proprietary technology results in the production of chromatography resins with a narrow, almost uniform particle size distribution, with excellent mass transfer properties that may be leveraged for process intensification. Herein, we present SMART cycling using our latest bioprocess Praesto Jetted Protein A chromatography resins.

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

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

Close of Advances in Recovery and Purification 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。

Choose your language
English


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