By David Westman, Global Product Marketing Manager BioProcess Chromatography Resins, GE Healthcare
Manufacturing biologicals is tricky. A major concern is the risk of microbial contamination, jeopardizing product safety and causing high costs. But there are solutions for decreasing the risks.
Making monoclonal antibody (mAb) drugs? Safety first
In releasing a biomedicine, the last thing a biopharma company wants is for people to be harmed. This makes the risk of bioburden, and how it can be prevented, a major issue for drug safety.
Thankfully, businesses and regulatory agencies share the same goal—to make every product safe and effective. Manufacturers and suppliers might have concerns with production economy, security of supply, and other operational issues, but their number one priority is always the health of the patient.