プレカンファレンスショートコース*

Monday, 10 October

Morning: 10:00-13:00

(SC1) APPLICATION OF PHAGE DISPLAY IN RESEARCH:
Library Generation, Selection, Affinity Maturation and Downstream Uses
(ファージディスプレイの研究応用：ライブラリーの生成、選択、親和性成熟、下流での利用)

• Protein Expression and Purification to Provide Reagents for Antibody Generation, and Downstream Consequences of Quality
• Application of Phage Display to High-Throughput Antibody Generation and Characterization
• Transforming Phage Display into a Convenient Tool for Everyday Research Work
• Recombinant Antibodies to Support Pharmaceutical Research

Instructors:

Michael R. Dyson, Ph.D., Biochemistry, University of Cambridge

John McCafferty, Ph.D., Research Director, Biochemistry, University of Cambridge

Stefan Dübel, Ph.D., Professor & Director, Institute of Biochemistry and Biotechnology, Technische Universität Braunschweig

David Lowe, Ph.D., Principal Scientist, Lead Generation, Department of Antibody Discovery and Protein Engineering, MedImmune Ltd.

Detailed Agenda

(SC2) SERUM HALF-LIFE EXTENSION
(血清半減期の延長)

An issue of many biologicals and antibody constructs is the short serum half-life requiring frequent dosing and other administrations of low convenience. This workshop will cover measures available to increase protein half-life (e.g., serum albumin-binding, Fc fusion, PEGylation) and slow release formulation.

• Technologies for half-life extension
• Comparing and contrasting advantages of each
• Validating technologies

Instructors:

Arne Skerra, Ph.D., CEO, XL-protein GmbH

Tommi Markkula, Ph.D., Head of Research, OctoPlus NV

Antony Godwin, Ph.D., Director, Chemistry, PolyTherics Ltd.

Detailed Agenda

Afternoon: 14:00-17:00

(SC7) KEY USES OF ORTHOGONAL TECHNIQUES AND STUDY OF PROTEIN AGGREGATION
(直交法の主な用途とタンパク質凝集の研究)

Despite large efforts in research and development, the number of new biotech products reaching the market is not high. One possibility to increase the success rates is to improve the formulation of the medical proof-of-concept studies. Protein aggregation is one of the most common issues in the development of new biopharmaceuticals. The workshop will present protein case studies and newly developed orthogonal analytical methods to analyze protein aggregation and to develop enabling formulations. The regulatory analytical requirements will be presented.

• Strategies to Detect and Address Protein Aggregation
• Review of Analytical Methods
• Impact of Formulation on Success of Proof-of-Concept Studies
• Automation for High-Throughput Formulation
• Meeting FDA Requirements for Analysis

Instructors:

Tudor Arvinte, Ph.D., Co-Founder, Therapeomic Inc.; Professor, Department of Pharmaceutics, University of Geneva

Martinus Capelle, Ph.D., Staff Scientist and Biopharmaceutical Project Manager, Therapeomic AG

Detailed Agenda

(SC8) CHARACTERIZATION OF BIOLOGICS: Comparability, Assay Development and Characterization Techniques
(生物製剤の特徴づけ：比較可能性、アッセイ開発、特徴づけの手法)

• Overview of current methods used for analyzing/characterizing biologic compounds
• Assay development considerations for naked antibodies vs. ADC compounds
• Stability indicating assays under development – lessons learned to date regarding degradation pathways
• Case studies of Abs with different drug/linker

Instructors:

Michael Buckley, Ph.D., Vice President, Process Sciences, Takeda San Francisco

Eike Hoffmann, Ph.D., Pharma Research and Early Development (pRED), Protein Biochemistry, Roche Diagnostics GmbH

Jennifer Nemeth, Ph.D., Principal Research Scientist, Biologics Mass Spectrometry & Allied Technologies, Centocor R&D, Inc.

* カンファレンスとは別に参加登録が必要です