The Cell and Gene Therapy Catapult (CGT Catapult), an independent innovation and technology organisation specialising in the advancement of the cell and gene therapy industry, has announced that its Braintree Manufacturing Innovation Centre (Braintree MIC) has successfully received a Medicines and Healthcare products Regulatory Agency (MHRA) Manufacturers and Importers Authorisation for Investigational Medicinal Products (MIA(IMP)) and associated Good Manufacturing Practice (GMP) certificate.
The MHRA licence, which was issued following a successful site inspection at the end of 2023, will allow the CGT Catapult to work with therapy developers to accelerate the large-scale manufacturing of their advanced therapy medicinal products (ATMPs). CGT Catapult will work with collaborators, using the latest in digital and data technologies, to optimise and scale-up their manufacturing processes, with the aim of lowering costs, reducing manufacturing timelines and producing safe, effective and high-quality products.
Located in Essex, UK, the Braintree MIC is a 4,627m2 (15,180ft2) site that consists of a new cleanroom module, quality control laboratories, warehouses, development laboratories and a team of 100 highly experienced and skilled staff, who hold the specialist knowledge needed to support collaborators to manufacture their own products. The work on the site is underpinned by a new GMP Pharmaceutical Quality System.
At Braintree MIC, the CGT Catapult has also developed and deployed new digital systems, analytical tools and cutting-edge scalable bioreactor platforms to support ATMP manufacturing. This included the technology transfer of an adeno-associated viral vector manufacturing platform from the CGT Catapult’s development laboratories in London. The digital systems, such as electronic batch manufacturing records, and Process Analytical Technologies, including RAMAN spectroscopy, will allow collaborators to improve the productivity and efficiency of their manufacturing processes.
Matthew Durdy, Chief Executive of the Cell and Gene Therapy Catapult, said: “With more advanced therapies entering clinical trials and being approved for use, there is a need to ensure that the UK has sufficient capacity and capability to manufacture these products at a scale not currently experienced. As the CGT Catapult’s second licensed Manufacturing Innovation Centre, we expect the Braintree MIC to play a vital role in meeting this need by providing a new GMP certificated space for developers to manufacture their products and work alongside the CGT Catapult to refine and intensify their manufacturing process, resulting in lower costs and high-quality products.”
