Manufacturing Standards for Biopharmaceuticals: A Conversation With NIST’s Sheng Lin-Gibson and Vijay Srinivasan

A gloved hand holds a syringe in a plastic case.

Biopharmaceuticals, also known as biological drugs or biologics, are manufactured from living organisms or contain living organisms that have been genetically engineered to prevent or treat diseases. Biologics are chemically and structurally complex, and often highly heterogeneous; therefore, controlling and maintaining quality remains a challenge. The potential for new therapeutics to cure and treat previously untreatable diseases is enormous, but there is still a long way to go before they can be manufactured at the required scale, with predictive control of quality, and at a lower cost. We sat down with NIST’s Vijay Srinivasan and Sheng Lin-Gibson to discuss their recent paper on some of the challenges and solutions associated with manufacturing these life-saving drugs.