The Cell and Gene Therapy Catapult is designed to transform the UK’s capability for innovation in cell and gene therapy and help drive future economic growth. However, we are not just innovating inside our laboratories, this innovation extends to how we work and our operating models.
Responding to market needs
The UK has traditionally excelled at the early R&D stages of developing new products; we can lay claim to inventions from the lawnmower to the light bulb, and more recently the world-wide-web and monoclonal antibodies. However, it is in commercialising these inventions where we have fallen short.
CGT Catapult was established by Innovate UK to drive the growth of the cell and gene therapy industry and support the industry in overcoming barriers to commercialisation. Through industry research, it was clear that a solution to address the challenges faced in developing large-scale manufacturing systems for this emerging industry was needed.
Unlike in more mature therapeutics markets, with cell and gene therapy products, there is significant innovation and considerable value in the production process. There is a lot of development work needed before the industry achieves stable, well understood and cost-efficient manufacturing platforms.
A unique proposition
The CGT Catapult manufacturing centre offering is unique. The centre is focussed around architecturally independent modules in which collaborators can access the capabilities needed to develop their propietary manufacturing platforms in an environment suitable for clinical supply. Collaborators can also contribute to, and benefit from, the development of shared platforms, such as supply chain, waste handling, and product tracking, to assist the manufacture of cell and gene therapies. The modules are completely configurable to the requirements of autologous, allogenic or viral vector processes, and allow the collaborator to control their process and retain their IP and know how while accessing a range of capabilities in the cluster around the centre.
It is not just the module that the centre will provide. The supporting infrastructure includes a quality management system, GMP warehousing, environmental monitoring, quality control and the services of a Qualified Person if required. CGT Catapult is also actively facilitating the growth of the cell and gene therapy supply chain in the area surrounding the centre, including the location of the Fisher BioServices CryoHub at the site which provides cryo-storage, logistics and secondary packaging. Trakcel will also provide a needle to needle supply chain management system for collaborators to link not only to their own systems, but also to the centre and the Fisher BioServices CryoHub.
Supporting cell and gene therapy companies
The centre is suitable for a company looking to develop large-scale manufacturing systems to support clinical development and all the way to commercial supply. The support structure provided by CGT Catapult removes the time, risk and resource burden that building and operating a new manufacturing centre would bring, allowing companies to develop and test their manufacturing processes.
Since we are working with companies in the centre to develop their systems and the systems of the future industry, the centre has been established on a collaboration and cost sharing model, providing significant economic benefits and transparency.