Accelerated Transfer for the Manufacture of an in-licensed Oncology Compound

Situation: Our client in-licensed an anti-cancer compound and requested Phase II immediate release tablets released to the US and EU within 5 months of Request for Proposal. Executed batch records and the development history of the drug product were not available.
Task: With limited information and using IND documentation, an accelerated transfer plan was initiated.
Action: Engineering batches were expeditiously manufactured to identify and evaluate materials, site transfer equipment and define critical process parameters. The manufacturing multi-step process consisted of wet granulation, compression and coating that was targeted to match the Phase I product specifications. In concerted efforts with engineering batch manufacturing activities; analytical methods - materials/cleaning/Bulk product /Finished Product - were evaluated and validated.
Result: The resulting product was manufactured within the client’s specified timeline, on budget and met all release specifications stated in the filing.