MHRA greenlights CGT Catapult UK center to produce ATMPs

According to the firm, the facility aims to accelerate the development of good manufacturing practice (GMP) manufacturing operations for advanced therapies at a clinical and commercial scale.

Located in Essex, UK, the Cell and Gene Therapy Catapult’s (CGT) manufacturing innovation center (MIC) is a 49,804 square-foot site. It is managed by a team of 100. Additionally, the site consists of a new cleanroom module, quality control laboratories, warehouses, and development laboratories

“CGT Catapult strives to help companies, researchers and innovators to accelerate their cell and gene therapies to market throughout development, manufacturing and clinical adoption,” a spokesperson for Catapult told BioProcess Insider.

Confirming the issuance of the Medicines and Healthcare products Regulatory Agency (MHRA) license following a successful site inspection at the end of 2023, the spokesperson added, “[this] will allow the firm to work with therapy developers to accelerate the large-scale manufacturing of their ATMPs.”

Furthermore, the CGT Catapult said they will collaborate with others using digital and data technologies, to optimize and scale-up their manufacturing processes, with the aim of lowering costs, reducing manufacturing timelines and producing safe, effective and high-quality products.

“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,” the spokesperson said.

The facility has also developed and deployed new digital systems, analytical tools and scalable bioreactor platforms to support ATMP manufacturing. This included the technology transfer of an adeno-associated viral vector (AAV) manufacturing platform from the CGT Catapult’s development laboratories in London.

“The digital systems, such as electronic batch manufacturing records, and process analytical technologies (PAT), including RAMAN spectroscopy, will allow collaborators to improve the productivity and efficiency of their manufacturing processes,” the spokesperson added.

Established in 2020, the Braintree facility was aided by a £100 million ($128 million) grant by the Department for Business, Energy and Industrial Strategy (BEIS). The aim of this facility was to support the national and international response to the COVID-19 pandemic producing vaccines at a large scale.

Having met the demand, the vaccine manufacturing capabilities were to be transferred to Vaccines Manufacturing and Innovation Center (now acquired by Catalent), while the Braintree facility would focus on CGTs.