Short Courses*
MONDAY, AUGUST 3
Morning Short Courses | 9:00-11:30 am
SC1: Optimizing Media – Achieving Super Soup - Detailed Agenda
To grow mammalian cells, researchers need to provide an optimal in vitro environment. The key feature of successful cell growth is the culture medium. ‘Achieving Super Soup’ requires finesse and know-how in order to combine the right ingredients at the right times under the right conditions to achieve high titers. This workshop will provide a foundation for optimizing cell culture media presented by real-world experts who will also tailor a portion of the course to fit concerns and challenges faced by the workshop participants.
Instructors:
Michael Butler, Ph.D., Distinguished Professor, Animal Cell Technology, Microbiology, University of Manitoba
David Brühlmann, MSc., Biotech Technology and Innovation, Biotech Process Sciences, Merck Serono SA
Kamal A. Rashid, Ph.D., Director, Biomanufacturing Education & Training Center, and Research Professor, Biology and Biotechnology, Worcester Polytechnic Institute
SC3: Accelerated Stability Testing of Biologics - Detailed Agenda
This short course will aim to guide the researcher in designing studies for accelerated stability testing of biologics. The course will begin with basic underlying concepts governing protein drug product stability, and focus on design principles for measuring stress and accelerated stability testing of not only the protein of interest, but also of excipients and primary packaging components. Strategies to handle complexities arising from their interactions will also be discussed.
Instructor:
Jan Jezek, Ph.D., CSO, Development, Arecor Ltd.
Sanket Patke, Ph.D., Research Investigator, Drug Product Science and Technology, Pharmaceutical Development, Bristol-Myers Squibb
TUESDAY, AUGUST 4
Dinner Short Courses | 6:00-8:30 pm
SC4: Analytical Strategies for Comparability in Bioprocess Development - Detailed Agenda
Bioprocess changes can impact quality attributes of biologics and may affect efficacy and/or safety of the product. During development and throughout the product lifecyle, when process improvements are implemented, it is essential to gather sufficient data to support the conclusion that product safety or efficacy has not been adversely affected. This demonstration exercise requires careful planning of the comparability studies and is based on the background knowledge of protein structure, biological function, and clinical attribute profiles of the product accumulated during development.
In this short course, we will discuss the key concepts of defining critical product quality attributes, the common analytical characterization technologies used, considerations in process monitoring and controls, and the iterative process of demonstrating comparability of the product in support of process changes.
Instructor:
Christine P. Chan, Ph.D., Principal Scientist/Technical Lead, Manufacturing Science & Technology, Genzyme – a SANOFI company
SC5: Operational Excellence Strategies for Bioprocessing – QbD, DoE and PAT - Detailed Agenda
Ensuring quality in bioprocesses that complies with regulatory requirements and mitigates risk often results in very high bottom-line costs. Adopting best practices early in the development process and customizing these approaches to operational excellence from other highly competitive industries are currently taking place in biopharmaceutical production. This course will provide both an overview of these approaches and how they work, as well as case studies of how these innovations have been applied successfully in bioprocessing and the development of biopharmaceuticals. Appropriate regulatory guidance will also be discussed.
Instructor:
Elizabeth Rebeil, Associate Director, Operational Excellence, Shire Pharmaceuticals
SC6: Protein Aggregation: Mechanism, Characterization and Consequences - Detailed Agenda
Protein aggregation is recognized by regulatory agencies and the biopharmaceutical industry as a key quality attribute of biotherapeutic products. Various aggregates hold the potential for adversely impacting production and patients in a variety of ways. This in-depth workshop 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.
Instructors:
Thomas Laue, Ph.D., Professor, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire
David F. Nicoli, Ph.D., Vice President R&D, Particle Sizing Systems, LLC
THURSDAY, AUGUST 6
Dinner Short Courses | 6:30-9:00 pm
SC9: Transient Protein Production in Mammalian Cells - Detailed Agenda
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, Research Scientist, Molecular Sciences, Alexion Pharmaceuticals
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.
* Separate registration required.