International – Mechanical, material stresses affect drug quality

Making medicines is a stressful business, literally. Bioprocessing technologies, cleaning agents, and even packaging can create stresses that impact drug quality. Understanding these stresses is the first step towards addressing them, says Tapan Das, PhD. senior director of product development at Bristol Myers Squibb, the author of a new study examining how production affects the quality of ingredients and finished drugs. Das had previously published a paper on the topic two years ago.

“While there are several common stress factors across drug substance manufacturing, product manufacturing, and packaging, there are some specific ones to the unit operations in substance or product manufacturing,” he points out…