Case #2: API Custom Synthesis and Formulation Development

An emerging pharmaceutical company in-licensed an API that had only been made at the gram scale at the innovator company. As the emerging pharmaceutical company was completely virtual, with no synthetic chemistry or pharmaceutical development labs, they were completely reliant upon outsourcing to meet their demanding project timelines. The company needed a stable liquid final dosage form for a labile, water sensitive molecule.

Acting as the general contractor, DavosPharma was able to provide suitable manufacturers for synthesis of two key intermediates, one of which was highly potent, and a third manufacturer capable of assembling the API in an FDA inspected high containment facility. The innovator company provided a synthetic process to the emerging pharmaceutical company that yielded API that was <85% pure after HPLC chromatography. By the time process development was complete at the API manufacturer, chromatographic isolation had been eliminated and the purity of the isolated API obtained using standard precipitation techniques was >97%, a purity suitable for use in tox and Phase I studies.

Simultaneously, DavosPharma partnered with a formulation development firm to investigate alternative formulations for the API. The formulator developed the appropriate liquid formulation, conducted required stability testing, and upon delivery of the API, manufactured sufficient formulated vials to meet all of the customer's Phase I clinical needs.