Abstrait

Trends regarding viral barrier implementation in animal cell culture processes

Sean Delfosse, Melissa Sathavipat, Nathan Hsu, Matthew Croughan* and Michelle LaFond

Over the past 20 years, a handful of large-scale viral contaminations have been reported along with various strategies, technologies and best practices for mitigation of adventitious viral and mycoplasma contaminations in upstream cell culture processes. Despite the available information, many uncertainties exist regarding implementation of viral barriers for upstream processes. Focusing primarily on high-temperature, short-time treatment of cell culture medium, this White Paper describes the current state of implementation of in-process, upstream viral barriers. It includes blinded data and insights from 12 leading biopharmaceutical companies, as well as six industry-leading consultants. Among 12 companies included in the study, a total of 24 high-temperature, short-time units are currently, or will soon be, in operation. The results generated are beneficial as a guide for viral risk-mitigation efforts, at both established and start-up biopharmaceutical companies.