11月12日 (一)、11月13日 (二)
第1天: 13:30 – 18:20 第2天: 8:30 – 18:30
TS6A: Basic Technologies in a Protein Production Lab
This seminar is designed to introduce basic technologies, strategies and considerations in recombinant protein production in E. coli, insect and mammalian cells for multiple research and development applications. The seminar supplies a basic toolbox for management of multiple and diverse projects.
Tsafi Danieli, PhD, Director, BioGiv Excubator & Head, Protein Expression Facility, Wolfson Centre for Applied Structural Biology, Alexander Silberman Institute of Life Sciences, The Hebrew University of Jerusalem
Mario Lebendiker, PhD, Head, Protein Purification Facility, Wolfson Centre for Applied Structural Biology, Alexander Silberman Institute of Life Sciences, The Hebrew University of Jerusalem
TS7A: Intro to Bispecifics: History, Engineering, and Application
Intro to Bispecifics will be organized as an informative and practical guide to get up to speed on critical aspects of bispecific antibody therapeutics. Topics will include historical successes, failures, and lessons learned. Specific practical instruction will span mechanisms of action, engineering, developability, regulatory considerations, and translational guidelines. Perspectives on ideal implementation of bispecifics as targeted and immunomodulatory approaches will be discussed.
G. Jonah Rainey, PhD, Executive Director, Head of Antibody Research, MabVax Therapeutics Holdings, Inc.
TS8A: Introduction to Protein Engineering
CHI’s Introduction to Protein Engineering training seminar offers a comprehensive tutorial in the concepts, strategies and tools of protein engineering – and explains the role of this discipline in the progression of biotherapeutic research and development. The class is directed at scientists new to the industry or working in support roles, academic scientists and career protein scientists wanting a detailed update on the current state of the field.
David Bramhill, PhD, Founder, Bramhill Biological Consulting, LLC and Research Corporation Technologies
11月14日 (三)、11月15日 (四)
Day 1: 8:30 – 17:45 Day 2: 8:30 – 12:45
TS6B: Rational Approaches to Biologics Formulation & Delivery
This course is intended to give participants an understanding of the basic principles of biologics formulation development, with an emphasis on maintaining long term product stability. Participants should expect to come away with a better understanding of biochemical and biophysical properties of proteins and peptides, and how excipients and other strategies can be used to mitigate degradation. Formulation development discussions will cover both liquid and lyophilized dosage forms. The focus of the session will be on maximizing efficiency during formulation development, with an eye on regulatory compliance throughout the product development lifecycle. Following an introduction to formulation development, we will cover more complex formulation development topics including strategies for the formulation of low solubility API’s, advice for the selection of container/closure systems and drug delivery devices, as well as the studies that must be performed to demonstrate the compatibility of those materials with the product.
Christina Vessely, PhD, Senior Consultant, CMC, Analytical and Formulation Development, Biologics Consulting
TS7B: Next-Generation Sequencing for Antibody Discovery and Engineering
In this training seminar, participants will learn about Next-Generation Sequencing (NGS) of antibody repertoires. Part 1 will provide an introduction to the antibody repertoires, consisting of genetic background, generation of diversity, sequencing technologies and a hand-on session on the computational tools available for the analysis antibody repertoire NGS data. Part 2 will focus on the preprocessing and analysis of data. Each step of the preprocessing will be elucidated using the programming language R along with existing bioinformatics pipelines available. Repertoire analysis content will provide statistical quantification and visualization of high-dimensional data. The course will be fully interactive with case studies, participants will be able to download data and example scripts. Please bring your computer.
Sai Reddy, PhD, Assistant Professor, Biosystems Science and Engineering, ETH Zurich, Switzerland
Simon Friedensohn, MSc, Research Assistant; Biosystems Science and Engineering, ETH Zurich, Switzerland
Thursday, 15 November and Friday, 16 November
Day 1: 14:00 – 17:00 Day 2: 8:30 – 15:35
TS6C: Potency and Comparability for Cell and Gene Products
Potency assays are an essential concept in determining the quality of any biological medicinal product/biologic. Extending this concept to cell, gene and tissue products is more challenging and often the most difficult aspect of characterising these products. The relevance of the approach taken is often challenged by regulators both during development and when seeking market approval. Change is inevitable and necessary both in development and over the post-approval product lifecycle. Whenever changes are made it is necessary to confirm they do not adversely impact the quality and therefore safety and efficacy of the product; this requires data beyond meeting current specifications. With any biological product this is challenging; for cell, gene and tissue products that cannot be fully characterised the challenges are greater still. Any development program should therefore aim to ensure the tools are in place to allow changes to be implemented. How characterisation and process development provide these tools will be discussed.
Christopher A. Bravery, PhD, Consulting Regulatory Scientist & Director, Advbiols
TS7C: Introduction to CAR-T Engineering for Protein Scientists
This course is intended for academic and industry scientists new to the field of CAR-T immunotherapy, and it offers an overview of basic concepts, strategies and tools in CAR-T development. Topics will include the history of the CAR-T field, CAR structure and function, approaches to CAR gene delivery, target selection, the impact of CAR linkers and structural domains on function, multi-targeting CAR constructs, and the emerging technologies for temporal and spatial control of CAR-T function.
Dina Schneider, PhD, Manager, Cell Biology Lentigen Technology, Inc.