High Potency Handling Capabilities And Support

Highly potent active pharmaceutical ingredients (HPAPIs) are essential in modern drug pipelines, particularly in oncology, for developing therapies with high selectivity and pharmacological activity. However, manufacturing these compounds presents significant challenges in Chemistry, Manufacturing, and Controls (CMC), primarily due to the stringent containment needed to protect both personnel and facilities from exposure. Furthermore, their production requires exceptional precision and control because the final dosage form often contains very small quantities of the drug.

Specialized facilities in the UK and US have been established and audited by major global regulatory agencies, offering a complete, global end-to-end development solution. Key features include multi-purpose manufacturing with single-pass HEPA filtration, negative pressure rooms, hard shell and flexible containment, and comprehensive EHS protocols.

Discover a broad range of development and manufacturing services for HPAPIs, from preclinical formulation screening to commercial manufacturing. Download the full info sheet to explore capabilities including API characterization, stability storage, clinical trial manufacturing, and advanced cross-contamination protections.