Tender notice
KCL-00000940 The Manufacture of a GMP-Grade Drug Product
Notice details
- Published
- Category
- services
- Buyer region
- London
- Source
- View official notice
Public buyer
Public buyer
King's College LondonTender valueNot disclosed
- Planned startAs published in the notice
- Planned endAs published in the notice
Work 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.
Additional information: Is a Recurrent Procurement Type? : No