Helen Clark, Head of Global MSAT at Bora Pharmaceuticals, shares insight on the capabilities needed to produce complex OSD drug products reliably in the U.S., covering HPAPI handling, Quality by Design and raw material planning.
HPAPI and Controlled Substance Handling
High-potency APIs and controlled substances require specialized containment systems that meet stringent occupational exposure limits.
Quality by Design in Tech Transfer
A QbD approach ensures critical process parameters and quality attributes are understood before transfer, reducing failures and delays.
Equipment Consistency Across Scales
Using the same equipment brand across lab, clinical and commercial scales helps process parameters translate directly and lowers scale-up risk.
Raw Material Planning
Strategic inventory and multiple qualified suppliers protect against disruption and keep supply continuous.
About This White Paper
This white paper is published by Bora Pharmaceuticals and curated by Biotechnology Media Insights, a trusted source for pharmaceutical and biotechnology research, technical guides and industry analysis.