Cell and Gene Therapy Catapult approach to GMP Manufacturing in the UK

The Cell Therapy Catapult’s aim is for the UK to become a global leader in cell therapy development and commercialisation, and considers Manufacturing and Supply Chain as one of the barriers to the translation of research into commercially viable products.

The UK is strongly positioned for early clinical phase manufacturing. A network of 14 early phase GMP manufacturing facilities is already in place, supplying over 1000m2 of licensed clean room space, and a strong track record of delivery for clinical programs with a diverse range of projects.

The Cell Therapy Catapult has been awarded £55m to design, build and establish a large-scale manufacturing centre that will be used for late phase manufacture and commercial supply. This facility will augment the network of early phase centres and, along with them, allow a product to be translated from early research, into the clinic and to commercial supply all within the UK.

This document outlines the Cell Therapy Catapult’s approach for promoting and developing the UK cell therapy manufacturing industry. The goal is to make the UK a global leader for cell therapy manufacture and supply. Due to their inherent complexity, manufacturing centres for cell therapy products are unlikely to be very portable. Also, the requirement for ongoing product and process understanding means that research and development centres are often co-located. Therefore manufacturing can help investments ‘stick’, retaining immediate and additional economic benefits for the UK.

The Cell Therapy Catapult’s Manufacturing Approach

The Catapult has a two pronged approach to cell therapy manufacturing:

Publish, Promote and Develop the existing Early Phase manufacturing network

Establish Late Phase and Commercial capacity by building a new large-scale cell therapy manufacturing centre by 2017 and operating it as part of the Cell Therapy Catapult

Early Phase Capacity

Publish: The first activity to support early phase manufacture is the publication of the “UK Manufacturing Capability and Capacity Report”. This report documents the collective technical capability and GMP capacity of the UK. This document shall be published on the Cell Therapy Catapult website and periodically updated.

Promote: The early phase manufacturing capability data shall be used by the Cell Therapy Catapult to promote the UK’s strong position in this area on the international stage, through various trade and governmental bodies as well as Cell Therapy Catapult international Business Development activities. It will also be used to highlight existing manufacturing capabilities, within the UK clinical development network.

Develop: The Cell Therapy Catapult will work alongside the existing GMP manufacturing centres to share best practice and help drive commercial innovation. This will be achieved through a project led manufacturing framework, established via a competitive EU tendering process and supported by workshops. By putting in place a framework, the Cell Therapy Catapult will be able to accelerate projects, both from outside and within the UK, into these centres.

Late Phase Capacity
By establishing the Cell Therapy Catapult Manufacturing Centre the UK translational value chain will be complete. New and exciting products can be translated from research into the clinic in the early phase network and once they reach later clinical phases they can be catered for within the large-scale centre. The centre will be designed, built and run as a subsidiary of the Cell Therapy Catapult and will be operational in 2017. The aim is to make this facility as flexible as possible so that it is able to work with many different types of cell therapy products and processing technologies.

Due to the hotel operating model and an innovative facility design it is expected that both Contract Manufacturing Organisations (CMOs) and product development companies will access space in the facility and once manufacturing operations are established and their local staff trained, they would then seek setup their own footprint. This model also allows the current early phase units to access commercial supply space, as needed.