A large pharma company was looking to transfer a wide-ranging portfolio of marketed consumer health products, some medicinal and some food supplements, from in-house GMP manufacture to third-party contract manufacturers. Support included: technical leader for tech transfer team, overseeing product risk analysis and transfer planning; technical resource to perform in-depth CMC health check of existing operations; joint quality leader, managing analytical validations and transfers, and executing a large number of stability studies; on-site support at sending site and receiving sites. The support resulted in successful establishment of GMP operations at the CMOs and valuable data for decision-making on the commercial viability of products within the portfolio.
Early Phase Manufacture
A single asset development company was looking to establish a virtual development team to achieve proof of concept for a novel synthetic peptide. Support included: managing the secondary manufacturing of clinical IMP at CMO; arranging GMP audits of CMOs; coordinating clinical supplies for Phase 2 studies; selecting formulation development partner and overseeing development of an optimised formulation; technical and quality management of long-term stability studies; writing of CMC sections of Investigators’ Brochure and IMPD. As a result, several clinical studies were completed.