By Tim Sandle, Ph.D., Bio Products Laboratory Ltd.
Viral contamination can affect raw materials, cell culture processes, bioreactor contamination, and downstream processing. ICH's new draft guideline titled Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin is available for public comment through the FDA (ending Jan. 14, 2023) and through the EMA (ending Feb. 10, 2023).
While people don’t always think about the choreography of good scientific teamwork, there are factors that should be considered and skills that can be developed to increase a drug discovery team’s overall effectiveness and chance of success.
