Standardized Quality Metrics in the Pharmaceutical Industry

This month, the FDA is receiving feedback from the pharmaceutical industry on its proposed quality metrics program, which will be a set of metrics provided by biotech and pharmaceutical manufacturers to move the agency’s inspection schedule toward a more risk-based approach and alleviate the chances of drug shortages. Other stated… Continue reading

Biopharmaceuticals by the Metric Tonne

I wrote the cover article, “Future Factories for Manufacturing Flexibility”, for the current issue of Pharmaceutical Engineering about biopharmaceutical manufacturing. It came about from my interview with John Cox, executive VP of Pharmaceutical Operations and Technology at Biogen. Biogen, a biotech company with 18 biopharmaceutical experimental therapeutic drugs in development, most of which… Continue reading