PDA Letter Article

Highly Potent APIs: Balancing Patient and Operator Safety

by Rebecca Stauffer, PDA

When contamination control is discussed at a PDA conference, the concern is usually about how to protect product from potential contamination. But what about the operator? As more “highly potent” drugs enter the market, the manufacturing of these innovative therapies presents the potential to expose operators to receptors or enzymes that can cause cancer, mutations or other medical issues.