2016 Archived Content
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.
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.
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.
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.
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.
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.
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.
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.
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