A Successful Approach For Managing Unexpected Increases In Potency For HPAPIs

By Daniela Kovats, Fareva

Abstract: Contract development and manufacturing organizations (CDMOs) face the challenge of managing new active pharmaceutical ingredients (APIs) in development projects with less toxicity and pharmacology data than is sufficient to calculate an occupational exposure limit (OEL). That can be a risk when the drug substance is a potent compound. When Fareva Excella realized that a development project initially classified as an occupational exposure band (OEB)-4 highly potent API (HPAPI) had been later reclassified as an OEB-6 compound, the company upgraded a state-of-the-art containment production line to ensure operator safety and keep the project on track in less than one year.