FDA Issues Advice on Screening for Viral Contamination in Therapeutic Proteins

The FDA has offered suggestions for ways to filter out viral contamination during continuous manufacturing of therapeutic proteins, based on studies conducted within the Center for Drug Evaluation and Research.

The agency noted that therapeutic proteins produced in mammalian cell lines may end up with “retrovirus-like particles” from the host cells that are usually harmless but have been “shown to infect non-rodent cell lines.” It also notes the risk of external viral contamination from raw materials or personnel.

The FDA referred manufacturers to the International Council for Harmonisation guidance on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin (ICH Q5A), which takes a three-pronged approach to addressing viral safety risks, including the testing of starting material from cell banks, testing of raw materials and intermediates, and testing of viral clearance during the purification process.