The Cell Therapy Catapult has recognised the need to engage with established Manufacturing Partners to leverage existing expertise across the Cell Therapy industry in its pursuit of the rapid development, delivery and commercialisation of cell therapies.

The Cell Therapy Catapult has internal activities for analytical, process development and manufacturing proving with its facilities on the 12th Floor of Guy's Hospital. It is desired to partner with centres of excellence for clinical manufacturing activities.

The Cell Therapy Catapult is engaged in numerous projects with an array of diverse products, and therefore wishes to engage in a framework agreement with several suppliers covering a wide range of skills and capabilities in order that these can be leveraged when required.

In order to fulfil its mission, the Cell Therapy Catapult needs to have access to sufficient manufacturing outsource providers to be able to confidently deliver on current and future projects across the entirety of the cell therapy industry. These projects could be internal Cell Therapy Catapult projects or those for which the Cell Therapy Catapult is acting on behalf of a client or partner. For this reason the Cell Therapy Catapult is looking to engage with outsource providers who may be able to offer one or more desired services in the following lots:

Lot 1: Immune cell therapy manufacture (including gene modified immune cell therapy).

Lot 2: Pluripotent derived cell therapy manufacture (iPS or hES).

Lot 3: MSC and other multi-potent cell therapy manufacture.

Lot 4: Other somatic cell therapy manufacture.

Lot 5: 3D culture based cell therapy manufacture.

To enable the manufacture in the specific lots the organisation should have experience, expertise and technology that includes the following activities where relevant to the particular lot:

— MHRA MIA(IMP) license for cell therapy applications (or equivalent local license outside of the UK);

— HTA license for donor material procurement testing (or equivalent local license outside of the UK);

— Hosting of GMP audits;

— Tech transfer support for incoming processes, including ability to absorb Catapult staff into the facility to aid tech transfer;

— Preparation of batch documentation;

— Manufacturing technologies and capability to enable processes may include but should not be limited to:

- Non-enclosed processing (using MBSCs within grade B background or isolators within grade C or grade D background);

- Enclosed processing (using closed systems in a grade C or grade D background);

- Adherent cell culture in T-flasks, cell factories and on microcarriers in bioreactors;

- Suspension culture of cells in static mode and in bioreactors;

- 3D culture of cells on surfaces;

- Cell separation;

- Cell activation;

- Differentiation;

- Volume reduction and washing of cells;

- Aseptic vial/bag filling;

- Product labelling;

- Cryopreservation;

— QC analytical testing of final products, in-process controls and raw materials;

— QA batch review;

— QP release of clinical material;

— Regular project meetings to report progress.