Dinner SC 2: Tuesday March 10, 6:00pm – 9:00 pm Sub-Visible Particles, Aggregates and Impurities: Measurement, Characterization and Impact

Instructors:

Patricia W. Cash, Ph.D., Senior Director, Analytical Biotechnology, Biopharmaceutical Development, MedImmune, Inc.

Dean Ripple, Ph.D., Group Leader, Bioprocess Measurement Group, National Institute of Standards and Technology

Nadine Ritter, Ph.D., President & Senior Analytical Advisor, Global Biotech Experts LLC

Agenda outline:

1. Introduction to SVPs, Aggregates and Impurities

• Current regulatory expectations
• Mechanisms behind formation of soluble aggregates and SVPs
• Potential biological impacts

2. Overview of Aggregates

• Causes of aggregation
• Characterization
• Current concerns in the context of immunogenicity with examples
• Elimination of aggregates through protein refolding and high pressure dissociation and other methods

3. Technologies and Tools for Identification and Characterization

• Aggregates (Size exclusion SEC, AUC, FFF, etc.)
• Sub-visible (Microflow imaging, light obscuration, etc.)
• Comparisons between technologies regarding limits of detection
• Open Discussion on which approaches can be regarded as FDA compliant

4. Recent Experiences and Case Studies

5. Discussion with Q&A

Instructor Biographies

Patricia W. Cash, Ph.D., Senior Director, Analytical Biotechnology, Biopharmaceutical Development, MedImmune, Inc.

Dr. Patricia Cash is a Senior Director in the Analytical Biotechnology Department at MedImmune. Her group is responsible for developing and implementing analytical methods used for characterization, lot release, and in-process testing of all protein projects at various stages of development. Dr. Cash worked as Director of Biochemical Methods at sanofi Pasteur (1999-2007), a Senior Research Investigator at Bristol-Myers Squibb (1993-1999), and a Principal Scientist at Cytogen (1990-1993). She received her PhD from Rutgers University in Newark, NJ and an MBA from the University of Phoenix.

Dean Ripple, Ph.D., Group Leader, Bioprocess Measurement Group, National Institute of Standards and Technology

Dean received a Ph.D. from Cornell University in 1991. After a successful career at NIST developing methods and standards in thermometry, in 2010 he became Leader of the Bioprocess Measurements Group, which conducts research supporting biomanufacturing and health care. His own research focuses on new standards and methods for characterizing protein particulates. Dean has presented workshops on measurement issues to many industrial groups, ranging from petroleum producers to vaccination program coordinators. He has authored over 45 scientific papers on a variety of metrology topics. He is an active member of the NCSLI Healthcare Metrology subcommittee, the ASTM committee on the Manufacture of Pharmaceutical Products, and expert panels of the US Pharmacopeia. In recognition of his contributions, he has received awards from the Department of Commerce, ASME, and ASTM committee E20 on Temperature Measurement.

Nadine Ritter, Ph.D., President & Senior Analytical Advisor, Global Biotech Experts LLC