Highly Potent APIs: Balancing Patient and Operator Safety
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.
This means that manufacturers of highly potent APIs (HPAPIs) face the twin challenges of protecting both product and personnel. Methods for addressing these challenges served as the focus of the two concluding talks at the 2019 PDA Practical Application of Sterile Manufacturing Workshop, March 14, in San Diego.
The first talk from Richard Denk, Head, Sales Containment, SKAN, provided an overview of recent EU regulatory guidelines for cross-contamination in shared facilities along with a look at current technological ways to address HPAPIs (1), while the second talk from Amir Zandnia, Senior Project Engineer, Fresenius Kabi, provided a case study in implementing an HPAPI suite that includes lyophilization processes (2).