Morning Short Courses

Monday, 2 November 09:00 – 12:00

08:00 – 09:00 Short Course Registration

SC1: Engineering of Bispecific Antibodies - Detailed Agenda

Co-instructors:
Nicolas Fischer, Ph.D., Head, Research, Novimmune SA

Michela Silacci, Director, Discovery Research, Covagen AG, one of the Janssen Pharmaceutical Companies of J&J

By attending this interactive workshop, you will learn about the various approaches used for the engineering of bispecific antibodies and bispecific scaffold-based binding proteins. Different technologies will be compared, and examples for applications of bispecific antibodies in drug development will be presented with a focus on candidates that are currently being evaluated in clinical trials. Opportunities and challenges in the field of bispecific antibodies will be discussed.

SC2: Mutation and Selection Strategies for Multi-Parameter Antibody Optimisation - Detailed Agenda

Co: Instructors:
William Finlay, Ph.D., Senior Director, Global Biotherapeutic Technologies, Pfizer, Inc.

Orla Cunningham, Ph.D., Associate Director, Global Biotherapeutic Technologies, Pfizer, Inc.

In therapeutic antibody discovery, few lead molecules meet all of the demanding standards required to become a drug. As a result, most antibodies will require some form of engineering and optimisation. This course aims to help attendees navigate the complex workflows and technological options required to be successful.

SC3: CHO Cell Engineering - Detailed Agenda

Anton Bauer, Ph.D., COO, The Antibody Lab

Simon Fischer, Ph.D., Scientist, BP Process Development Germany, Boehringer Ingelheim Pharma GmbH & Co. KG

Zhiwei Song, Ph.D., Principal Scientist, Lead PI for GlycoSing Programme, Bioprocessing Technology Institute, A*STAR

Recombinant protein therapeutics have proven their worth as invaluable pharmaceuticals. Chinese hamster ovary (CHO) cells are the primary choice by industry for the production of these proteins, owing to their capacity for correct folding, assembly and posttranslational modification. The growing demand for therapeutic proteins necessitates the development of new technologies for high quality and productivity in CHO expression systems. This course explores CHO cell engineering strategies to improve and select for the highest producers.

SC4: Protein Purification Strategies: Dealing with Proteins that Are Prone to Aggregate - Detailed Agenda

Mario Lebendiker, Ph.D., Head, Protein Purification Facility, Wolfson Centre for Applied Structural Biology, The Hebrew University of Jerusalem

This course will provide a comprehensive and detailed outline of hands-on issues for purifying proteins. We will first address general considerations about the protein we want to produce, including issues of activity, solubility, homogeneity, purity, and proper oligomeric conformation. Aggregation is one of the main obstacles in protein production, so we will look at how to monitor for aggregation and comprehend its mechanism. We will also discuss how to check for the optimal solubility conditions at the expression level, and our comprehensive approach for optimizing solubility during purification. We will also discuss expression screening methodology, environmental factors to consider during purification, families of additives, and screening for additives. Lastly, we will address ways to avoid aggregation, as well as setting up protein concentration and storage.

Dinner Short Courses

Thursday, 5 November 17:30 – 20:30, To Include Dinner

17:15 – 17:30 Dinner Short Course Registration

SC6: Troubleshooting and Engineering of Antibody Constructs - Detailed Agenda

Co-Instructors:
Jonas Schaefer, Ph.D., Head, High-Throughput Binder Selection Facility, Biochemistry, University of Zurich

Julia Neugebauer, Ph.D., Associate Director, Leader Discovery Programs, MorphoSys AG

Recombinant antibodies vary widely in their biophysical characteristics, from stable monomers to metastable aggregation-prone oligomers. In particular, antibody variable domains differ in their intrinsic thermodynamic stability and may require labour-intensive engineering. It is therefore essential to implement antibody engineering strategies in screening and initial characterisation project phases in order to avoid time and cost consuming optimisation strategies in later development. In addition, it is critical to understand how the poor stability of individual variable domains not only limits the biophysical properties of small fragments, but also affects the production yield, stability and homogeneity of full-length IgGs containing these domains.

SC7: Immunotherapy in the 21st Century: More Specificity, More Potency, Better Targeting - Detailed Agenda

Co-instructors:
Christian Klein, Ph.D., Head, Oncology Programs, Roche Pharmaceutical Research & Early Development, Roche Innovation Center Zurich

Jos Melenhorst, Ph.D., Director, Product Development & Correlative Sciences Labs, University of Pennsylvania

Part One: Antibody-Based Cancer Immunotherapy

Christian Klein, Ph.D., Head, Oncology Programs, Roche Pharmaceutical Research & Early Development, Roche Innovation Center Zurich

This short course will give an overview of validated and emerging targets for cancer immunotherapy; mechanisms of action of antibody-based cancer immunotherapy; ADCC-enhanced antibodies and how to improve the immune effector function of antibodies; T cell bispecific antibodies and their comparison to CAR-T; and checkpoint inhibitory and agonistic antibodies

Part Two: Cellular Immuno-Gene Therapy of Cancer

Jos Melenhorst, Ph.D., Director, Product Development & Correlative Sciences Labs, University of Pennsylvania

I will discuss current cellular therapies of cancer, and how the synergy of basic biology, translational research, and biotechnology have allowed us to better target tumour cells, enhance the potency of our treatment, and look for new ways to collaborate across the immune system in achieving our goal of long-term remission in even poor risk patient groups.

SC8: The Challenge of Protein Aggregation and Formation of Sub Visible Particles in the Development of Biopharmaceuticals - Detailed Agenda

Tudor Arvinte, Ph.D., Chairman & CEO, Therapeomic, Inc.

Attendees of this 3-hour short course will gain a critical overview of the complexity and diversity of the aggregation and sub-visible particles of peptide and protein biopharmaceuticals and on strategies to overcome these issues. The course will cover different aggregation mechanisms; available techniques for detection of aggregation and impurities and how these methods can be applied; strategies for developing stable peptide drug formulations using HT analysis and HT formulation platforms; as well as aggregation of biopharmaceuticals in human plasma – a new development and research field.

SC9: Advanced Techniques for Characterisation of Protein Aggregates, Particulates and Contaminants - Detailed Agenda

Matthew Brown, Ph.D., Life Science Specialist, Malvern Instruments

Amber Fradkin, Ph.D., Associate Director, R&D, KBI Biopharma

Stacy Kenyon, Ph.D., Scientist, Bioscience Development Initiative, Malvern Instruments

Understanding the complex process of protein aggregation is key to the implementation of QbD approaches during biotherapeutic development or deviation resolution of legacy products. Such in-depth understanding relies on the implementation of advanced characterization technologies. Using these advanced techniques, the biopharmaceutical industry is now offered detailed insights into protein behaviour, allowing evaluation of product stability and process impact. This course will cover some of the latest technologies for advanced characterization of protein therapeutics, together with case studies from industry, on how such approaches can be implemented for product development and understanding.