In June of 1999, and fresh from her bachelor's degree in chemical engineering, Joan Kwong started working on a rotavirus vaccine in the fermentation and cell culture department. She was working for Merck, in bioprocess research and development, growing mammalian cells and infecting them with genetically engineered viruses. About four years later, she was tapped to help draft a biologic license application (BLA, an application for commercial sales of a biologic) to submit to the Food and Drug Administration. As part of the team, she worked with her former colleagues in the lab to describe the detailed methods used to make the vaccine and measure its impurities.
"At that point I had no experience at all on the regulatory side," says Kwong, who now works as a regulatory affairs associate at Pfizer. "I didn't know what a BLA was." Thrown into a completely new aspect of drug development, Kwong began ...
