End-To-End Development And Manufacturing In Support Of Small Volume Commercial Products

By Dan Bowles, Mike Johnson, and Brian Swierenga, Cambrex High Point

For sponsors developing and commercializing orphan drugs, continuity of CDMO partners proves to be equally, if not more challenging. In 2021, 52% of CDER-approved drugs held the orphan drug designation, many of which also had fast-track status. To keep these therapies on their development timelines, CDMOs must be able to scale quickly within their facilities to help therapies progress from early clinical development to validation and commercial launch. An unexpected technology transfer can have major implications for these sponsors.

Cambrex has recognized the lack of market options for true end-to-end (pre-clinical to commercial launch) CDMO support for orphan and small-volume drugs. Our vision is to support early API development and small-scale commercialization under one roof, backed by our large-scale manufacturing network support, should the sponsor need to scale as indications grow and API demands rise

Sponsors spend considerable time and resources on process development and validation to create a launch-ready manufacturing process, which might require minor refinement. More often, however, significant process refinement is needed when adding additional CDMOs in preparation for process validation and commercial launch. Our goal is to ensure the sponsor process is optimized and prepared for commercial scale across any site in the Cambrex network.