Short Courses*

MONDAY, AUGUST 15
MORNING COURSES | 9:00 – 11:30 AM

SC1: Optimizing Media for Culturing Cells - Detailed Agenda

This course will provide helpful strategies for improving process robustness, extending culture viability, and increasing productivity. The course will cover essential ingredients needed to culture cells, as well as new ways to replace traditional elements with chemically-defined components, and provide optimal culture conditions. Reducing process variability and influencing key product quality attributes will also be addressed.

Instructors:
Sara Gall, MS, Senior Engineer, Process Development, Drug Substance Technology & Engineering, Amgen, Inc.
Kamal A. Rashid, Ph.D., Director, Biomanufacturing Education & Training Center, Worcester Polytechnic Institute
Andrew Salazar, M.Sc., Ph.D. Student, Biomaterial and Technology Development, Merck Lifescience

Catherine Lynes, MSc., MEng., Associate Scientist II, Technical Development, Biogen

SC2: 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.

Instructors:
Jan Jezek, Ph.D., CSO, Development, Arecor Ltd.

Sanket Patke, Ph.D., Research Investigator, Drug Product Science and Technology, Pharmaceutical Development, Bristol-Myers Squibb

SC3: New USP Initiatives and Standards for Biologics

This short course will detail new USP standards for legacy products and the qualification of biologic raw materials. The course starts with a look at biological standards and future directions in the Pharmacopeia, followed by Chapters to assess viral clearance of starting materials and recombinant product; development of new Chapters for cell banking and cryopreservation, and modernization of monographs for animal- and human-derived biologics.

Instructor:
Fouad Atouf, Ph.D., Director, Global Biologics, U.S. Pharmacoepeia

Maura Kibbey, Ph.D., Director, Global Biologics, U.S. Pharmacopeia

SC4: Advanced Process Control Strategies in Bioprocessing - Detailed Agenda

This course is focused on critical issues during implementation of advanced process control strategies in bioprocesses. We will summarize specific aspects from data acquisition, data processing to advanced control strategies. We will also discuss software requirements for data management and process control within and along different process scales. The topic is strongly related to PAT/QbD implementation in bioprocesses.

Instructor:
Gerald Striedner, Ph.D., Assistant Professor, Department of Biotechnology, University of Natural Resources and Life Sciences, Vienna, Austria, Head of Working Group Fermentation Technology, Co-Founder of enGenes Biotech GmbH

TUESDAY, AUGUST 16
DINNER COURSES | 6:00 – 8:30 PM

SC5: Analytical Strategies for Comparability in Bioprocess Development - Detailed Agenda

Bioprocess changes can impact quality attributes of biologics and may affect efficacy and safety of the product. During development and throughout the product lifecycle, when process improvements are implemented, it is essential to gather sufficient data to support the conclusion that product safety and 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 establishing product quality profiles, defining control strategies, the common analytical characterization technologies used, and the hierarchical assessment approach to demonstrating comparability of the product in support of process changes.

Instructor:
Christine P. Chan, Ph.D., Principal Scientist/Technical Lead, Global
Manufacturing Science & Technology, Specialty Care Operations, Sanofi

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 biotherapeutics. 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.

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

SC7: Purification of Advanced Medicine Therapy Products - Detailed Agenda

Advanced Therapy Medicinal Products (ATMPs), defined as stem cell-based products, virus and virus-like particles, have a unique complexity that challenges the design of robust and effective biomanufacturing processes. Already established downstream processing steps should be rethought and redesigned to cope with the specific demands for these types of therapeutic products, maintaining their final quality attributes in terms of identity, potency, purity and safety. In this short course we will provide a comprehensive and detailed outline of hands-on issues for ATMPs´ purification and an overview of the main challenges that these type of products pose and how we can tailor current processes to fit their particular requirements.

Instructors:
Ricardo Silva, Ph.D., Researcher, Downstream Processing Lab, Animal Cell Technology, iBET – Instituto de Biologia Experimental e Tecnologica
Barbara Cunha, MSc, Animal Cell Technology, iBET – Instituto de Biologia Experimental e Tecnologica

THURSDAY, AUGUST 18
DINNER COURSES | 6:00 – 8:30 PM

SC10: 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 milligramto- 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, Inc.
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