Accelerated Transfer for the Manufacture of an Orphan Drug Product

Situation: Our client purchased the rights to an orphan drug with the stipulation that the product could not be manufactured at the original site.

Task: Facing marginal inventories and limited existing API, an accelerated transfer plan was critical to evaluate, source equipment, manufacture transfer batches and avoid a disruption in the marketplace of a medically necessary product.

Action: With the accelerated timeline and inventory shortages, AAIPharma scientists initiated the transfer characterization/ evaluation using the initial filing documentation, validation documents and recent batch history. Utilizing the experience base at AAIPharma with similar process/equipment trains, the registration and validation manufacture was performed concurrently to maximize efficiencies producing stability data and commercial inventory for the client. Included in this time frame was the initial analytical evaluation of methods - materials/cleaning/BP/FP and purchase/qualification of new equipment.

Result: The client requested expedited review and within approximately 8 months from initial signing of the transfer request, the client obtained FDA approval and manufacturing began using AAIPharma as the new FDA approved site.