4151/JN/24 - Dynamic Supplier List to Provide: Outsourcing of Quality Control Analytics for the Production of Adeno-Associated Virus (AAV)

The Gene Therapy Innovation and Manufacturing Centre (GTIMC) at the University of Sheffield is inviting submissions from qualified suppliers for the outsourcing of quality control analytics for the production of adeno-associated virus (AAV) in compliance with MHRA regulations to demonstrate product adherence to British Pharmacopoeia standards. The AAV gene therapy products manufactured by the facility are intended for clinical trials/therapeutic use, hence stringent quality control measures are required.

The GTIMC is one of three centres in the Innovation Hubs for Gene Therapies (IHfGT) network. This network is a new UK initiative designed to support the development and delivery of new gene therapy treatments. This is being achieved by offering academic and industrial clients large scale GMP AAV manufacturing, translational support and expert regulatory advice.

The primary objective of this tender is to identify capable suppliers to conduct quality control analytics on AAV gene therapy medicinal products produced by the GTIMC. The suppliers must demonstrate expertise in the relevant analytics assays, adherence to MHRA regulations for AAV characterisation and value for money and will be responsible for generating and communicating comprehensive results reports to the GTIMC.

This is an exercise to create a Dynamic Supplier List (DSL). The ITT can be downloaded by registering and expressing your interest on the University`s e-tendering system https://in-tendhost.co.uk/sheffield

If you have any questions or comments in relation to this tender they must be submitted via the In-tend system, this can be accessed at https://in-tendhost.co.uk/sheffield

Completed tenders must be returned through the same e-tendering system.

Suppliers can submit returns for the life of the DSL.