Dinner Short Courses*

Sunday, January 8 | 5:00-8:00 pm

SC1: Production Challenges for Complex Biologics: Antibody-Drug Conjugates and Fusion Proteins

This course addresses the typical production issues encountered with complex biologics, namely fusion proteins, antibody-drug conjugates and bispecific antibodies. Experts elucidate the structure and nature of these biologics in order to understand and master their properties. Along with exploring manufacturing challenges, the course also reveals how to overcome these challenges with practical insights and advice.

Instructors:
Stefan R. Schmidt, Ph.D., MBA, Vice President, Rentschler Biotechnology
Gang Gary Chen, Ph.D., Head, ADC Technology, Levena BioPharma

Laurent Ducry, Ph.D., Head, Bioconjugates R&D, Lonza Biologics, Inc.

SC2: A Modern Approach to Biologics Formulation Development

This course offers a forum on how to develop sound formulations for biologic drugs. Case studies will be presented to demonstrate how to incorporate QbD concepts to do risk assessment, design multivariate experiments, and assess critical quality attributes including subvisible particle characterization in order to develop robust formulation for bulk drug substance or final drug product in the context of designated container closure systems. This course utilizes real-world examples and interactive discussion.

Instructors:
Kevin Zen, Ph.D., Senior Director, Biologics Development, Allgenesis Biotherapeutics

Danny K. Chou, Pharm.D., Ph.D., President and Founder, Compassion BioSolution; Former Senior Research Scientist, Biologics Development, Gilead Sciences

Tuesday, January 10 | 5:45-8:45 pm

SC7: Ensuring Accelerated and Successful Drug Product Development of Biologics: Integrated Formulation Development, Process and Packaging Design

Suitable biotech drug product design is key to the success of patient treatment. The formulation, manufacturing process and primary packaging are integral components of the drug product. In addition, a focus on management of the interface of drug substance to drug product is essential for efficient and successful development. This short course is designed to discuss strategies on how to approach an appropriate design for a target product profile, formulation, primary packaging and manufacturing process. Hot topics in drug product development, including particulates, aggregates, container closure integrity, surfactant stability and low endotoxin recovery, will be further discussed.

Instructor:

Satish Singh, Ph.D., Head, Drug Product Process Development, Lonza AG

SC8: Next-Generation Sequencing of Antibody Libraries: Details on Experimental and Bioinformatic Methods

Next-generation sequencing (NGS) of antibody repertoires provides a quantitative approach to measuring the diversity and distribution of antibody libraries. This course enables researchers on how to design, analyze, and perform antibody NGS studies, which have applications in antibody discovery and engineering. We go over the practical details of antibody NGS (using the Illumina platform) including library construction and quality control, data processing and analysis, and advanced methods for improving accuracy by molecular barcoding and error correction.

Instructor:

Sai Reddy, Ph.D., Assistant Professor, Biosystems Science and Engineering, ETH Zurich

SC9: Troubleshooting and Engineering of Antibody Constructs

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 labor-intensive engineering. It is therefore essential to implement antibody engineering strategies in screening and initial characterization project phases in order to avoid time and cost consuming optimization 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.

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

Christian Kunz, Ph.D., Associate Director, Discovery Alliances & Technologies, MorphoSys AG

SC10: Protein Aggregation: Mechanism, Characterization and Consequences

Protein aggregation is recognized by regulatory agencies and the biopharmaceutical industry as a key quality attribute of biotherapeutics. Various aggregates hold the potential for adversely impacting production and patients in a variety of ways. This in-depth course reviews the origins and consequences of aggregation in biotherapeutics, and then examines strategies for predicting and quantifying aggregation in biopharmaceuticals. It benefits scientists engaged in development, production, analytical characterization and approval of biotherapeutics and who require a good working knowledge of protein aggregation.

Instructor:
Thomas Laue, Ph.D., Professor, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire

SC11: Transient Protein Production in Mammalian Cells

This short course introduces both the fundamental concepts and technologies needed to establish transient protein production in mammalian cells. This allows for the rapid generation, purification and characterization of milligram-to-gram quantities of secreted or intracellular recombinant proteins for therapeutic, functional and structural studies. The course combines instruction and case studies in an interactive environment.

Instructors:
Richard Altman, MS, Scientist, Protein Technologies, Amgen

Henry C. Chiou, Ph.D., Associate Director, Cell Biology, Life Science Solutions, Thermo Fisher Scientific

Dominic Esposito, Ph.D., Director, Protein Expression Laboratory, Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Inc.

Panelists:
Bram D. Estes, Scientist, Amgen

Elizabeth Greene, MS, Scientist, Immune Modulation and Biotherapeutics Discovery (IMBD), Boehringer Ingelheim

Brian Paszkiet, MS, Staff Scientist, Cell Biology, Life Sciences Solutions, Thermo Fisher Scientific

*Separate registration required