Development & Supply of Drug Product for Clinical Trials

Dstl (Defence Science and Technology Laboratory) has a requirement for a Contract Research Organisation (CRO) to undertake drug product development and supply to support a future Phase 1 Clinical Trial for a novel three-drug combination (known as “Triple Therapy”). Two of the drugs in the combination are licensed; one is a new drug candidate. The development of the drug product refers to the mixing of the three drug substances together in solution. The Triple Therapy is planned to be administered intramuscularly using a wet/dry autoinjector device. Due to the new drug substance being unstable in solution it will be located in a ‘dry’ chamber with the other two drug substances being located in a ‘wet’ chamber. Stability Studies will also be required for the drug product (Triple Therapy) and the two drug substance mixture (for the wet chamber). Tasks to be completed under any resulting contract may include (but are not limited to): • Drug product development (mixing of three drug substances into drug product); • Fill/Finishing into vials; • Sterility using gamma radiation; • Stability Studies; • Packaging and Re-labelling for Phase 1 Clinical Trials; • OPTION: QP Release of Investigational Medicinal Products. Studies must comply with the appropriate regulatory standards including current Good Manufacturing Practice (cGMP). All three drug substances will be provided by Dstl.

Reference number:DSTLX-1000072089

Deadline date:02/08/2012

This deadline is for…Deadline for Expression of Interest

Contract value:£10,000 – £113,000

Location where the contract is to be carried out:Gloucestershire, Wiltshire and North SomersetGloucestershire, Wiltshire and Bristol/Bath area,

Is this suitable for smaller suppliers?Yes

Name of the buying organisation:DSTL

Original source

Link to tender