KCL-00000940 The Manufacture of a GMP-Grade Drug Product

Tender description

King's College London seeks to appoint a supplier to provide a formulation development of a lyophilised PTL060 drug product service. The project requires formulation and process development to support manufacture of a GMP-grade lyophilised PTL060 drug product (DP) for ultimate use in clinical trials. The DP would be a single use product for reconstitution and dilution with Soltran perfusion media; 1 mg/vial PTL060 has been assumed. Following development of a suitable formulation, a pilot batch would be prepared and placed on short term proof of principle stability (up to six months). Batch records, Study Protocols, Certificates of Analysis and Release and/or other reports for work would be required.