Sponsored by Johnson & Johnson
The new FDA guidance provides important information related to performance of risk assessment of the current industry viral control strategies for SARS-CoV-2 virus related to cell culture manufacturing. According to the guidance, this risk assessment may include, but not be limited to the leverage of existing available information on the following:
- The potential of the SARS-CoV-2 virus to replicate in production cell lines.
- Whether current cell bank and harvest viral testing would detect SARS-CoV-2.
- The effectiveness of viral clearance and inactivation steps for SARS-CoV-2.
- Controls in buffer and media preparation areas.
This and other important areas covered in the guidance will be discussed including, general risk assessment on the manufacturing process when employees are identified as having had COVID-19, the exclusion of potentially infected employees from the workplace, the level of documentation of cleaning and disinfection in non-GMP areas, and the FDA expectation of the response by industry of viral events that may include employees identified as having had COVID-19 infections.
This webinar is intended to provide attendees the opportunity to better understand the expectations outlined in the guidance through a general discussion of the guidance as well as an open Q&A session that has been extended to allow ample time for questions. The panel will consist of both FDA and Industry representatives.
- Paul Barone, PhD, Associate Director, Biomanufacturing Research Program at the MIT Center for Biomedical Innovation
- Tony Cundell, PhD, Principal Consultant, Microbiological Consulting LLC
- Thomas Kreil, PhD, Vice President Global Head Pathogen Safety, Takeda
- Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, ORA, U.S. FDA
- Peter Qiu, PhD, Division Director (Acting), Office of Pharmaceutical Manufacturing Assessment, U.S. FDA
- Joel Welch, PhD, Associate Director for Biosimilar and Regulatory Policy (Acting), OBP, U.S. FDA