Benchmarking Study to Evaluate Trends for Viral Barrier Implementation in Commercial Cell Culture Processes

Nearly twenty years have passed since Genentech reported the first large-scale contamination of commercial cell culture operations by Mouse Minute Virus (MMV). Since then, a handful of large-scale 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 this shared information, many uncertainties exist regarding implementation of viral barriers for upstream cell culture processes.
Focusing primarily on High Temperature, Short Time (HTST) treatment of cell culture media, we conducted a benchmark study of the current state of implementation of in-process, upstream viral barriers, and also evaluated the challenges companies have faced in regards to this topic. The results generated are beneficial as a guide for viral risk mitigation efforts, at both established and start-up biopharmaceutical companies.
This study surveyed nine leading biopharmaceutical companies, as well as six industry-leading consultants, who were able to share insights into the regulatory landscape and potential hurdles, scalability challenges, best practices for viral inactivation and validation studies, as well as the impact to cost of goods.