Technical Transfer of DST-F to CMO

This Contract is for Technology Transfer Services for DST-F manufacture from the Supplier's pilot scale facility to the appointed Contract Manufacturing Organisation (CMO). The Supplier currently manufactures the research-grade product. As the programme progresses towards Marketing Authorisation (MA) and commercial-scale manufacture, the DST-F production process must be Technically Transferred from The Suppliers pilot-scale facility to an appointed GMP-certified CMO.

The CMO has been appointed by means of a competitive flexible tender process, which is a separate requirement and contract to this Contract.

Technology Transfer is the collaborative process of moving scientific findings, intellectual property, and technical knowledge from creators to the CMO to develop commercial manufacturing. The process involves transferring data, designs, software, inventions, and expertise between organisations.

The Technology Transfer Services are necessary to:

• Support knowledge transfer
• Support documentation provision
• Provide expert technical advice to enable the CMO to commence GMP manufacture
• Support MA submission activities.