KCL-00000940 The Manufacture of a GMP-Grade Drug Product
King's College London · London
Key facts
- Closing date
- 25 Mar 2017
- Contract starts
- 30 Apr 2017
- Contract ends
- 30 Apr 2018
- Procedure
- Open procedure
- Buyer type
- Education
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
Categories (CPV)
- 33698000 Clinical products
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