ACT2 Study · UK public procurement notice

Our decision to exclusively source the Newcastle Advanced Therapies Facility (NATF) to manufacture the chondrocyte therapy is founded on several irrefutable factors.

The Newcastle facility has a track-record in academic and commercial translational cell-therapy partnerships including DPFS funded programmes. They have successfully completed technical transfer and validation, compiled validation data and authored IMPDs for the successful submission and approval by the MHRA of several autologous and allogeneic products with some resulting in Phase I/II clinical trials. (EudraCT 2023-000020-11, EudraCT 2014-001476-63).

The funding requirements and the current project status require the manufacturer to be in a position to commence manufacture within 4 months. Consequently, the project requires a dedicated clean room for the project, which NATF are able to provide with immediate effect. The NATF laboratory has been working with us on the project for the last 6 months in order to satisfy our Quality control testing for the project. NATF are therefore familiar with the project and the manufacture process. They are the only facility we are aware of that can provide, within the restricted budget, the GMP grade flow cytometry and Karyotype assay requirements. With regards to the additional QC testing requirements, the Newcastle team have close relationships underpinned with valid technical agreements with several contract laboratories and have worked with them to validate all the tests required for ACT2. QC test validation work undertaken to date is also directly transferrable (and does not require repeating), e.g. our mycoplasma product work-up with Mycoplasma Experience (also used by the Newcastle facility). This provides the researchers with the opportunity to rapidly transfer and implement manufacturing protocols, ensuring, as best as possible, that the future timelines of the project are met. It is anticipated that the manufacture protocols of the new therapy can be easily embedded within the facility and minimise the training requirements, hence facilitating a relatively early adoption.