FDA Wants More Efforts to Guard Against Viruses in Biologics

The FDA is expecting biologics manufacturers to work harder to reduce the possibility of adventitious virus contamination at contract manufacturers, as well as their own sites, after recent significant and preventable contaminations, Rick Friedman, director of CDER’s Division of Manufacturing and Product Quality, said. The agency is also finding “too many significant issues” between manufacturers and their contractors, such as quality assurance ethics that are not compatible with each other, Friedman said at the PDA/FDA Adventitious Viruses in Biologics workshop in Bethesda, Md. He noted the FDA has issued warning letters to both sponsors and contract manufacturers.
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