SC14: USP Standards to Support Quality of Potency Measurements

THURSDAY, MAY 7 | DINNER, 5:45 – 8:15 PM

ABOUT THIS COURSE:

USP’s innovative public standards for bioassays have supported potency measurements for decades. Standards range from best practices for development, validation, and analysis of bioassays in general to more specific issues such as Fc receptor assay function or new in vitro assays to replace in vivo assays. This course will delve into the current state of documentary standards as well as new biologics reference standards that support product quality and consistency over time.

WHAT YOU WILL LEARN:

  • History of USP Standards
  • What is a potency measure?
  • USP bioassay chapters and revision status of chapters <1032> and <1033>
  • New General Chapter <1108> to support Fc receptor assays
  • New biologics Reference Standards that are fit for purpose
  • Use of standards to support potency measurements, trending, and stability testing

INSTRUCTOR BIOGRAPHIES:

Kibbey_MauraMaura Kibbey, PhD, Senior Scientific Fellow, Education & Training, Global Biologics, USP

Dr. Maura Kibbey is a Senior Scientific Fellow for Education and Training in USP’s Global Biologics Department. Dr. Kibbey leads development of courses, workshops, and forums to engage USP’s biologics stakeholders. This role builds on her previous responsibilities directing USP scientists developing compendial standards. Before joining USP, Dr. Kibbey worked for several biotechnology and diagnostic companies in the Washington DC area in scientific, management, marketing, and business development roles, as well as performing cancer research at the National Institutes of Health. She has published over 40 peer-reviewed articles and has been an invited speaker or workshop organizer for numerous scientific conferences.

walfish_StevenSteven Walfish, MBA, Principal Scientific Liaison, USP

Mr. Walfish is Principal Science & Standards Liaison in the Global Science and Standards Division at United States Pharmacopeia (USP). Prior to this role Mr. Walfish was Principal Statistician at BD in Franklin Lakes, NJ. Steven was President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to the FDA regulated industries. He holds a Bachelors of Arts in Statistics from the University of Buffalo, Masters of Science in Statistics from Rutgers University and an Executive MBA from Boston University.