The UK Medicines and Healthcare products Regulatory Agency (MHRA) authorized RoslinCT to manufacture cell therapy products in March, and the agency authorized exa-cel on Nov. 15.

According to RoslinCT, both companies had already been working closely on an adaptive basis as Vertex progressed its clinical and regulatory development to bring this world-first therapeutic to patients.

RoslinCT claims to have extensive process development expertise and cGMP manufacturing capability across a broad range of autologous and allogeneic cell therapies, with comprehensive expertise in gene editing and induced pluripotent stem cell (iPSC) capabilities. The company has manufacturing facilities for cell therapy products in Edinburgh, Scotland and Boston, US.

Peter Coleman, CEO of RoslinCT UK said: “RoslinCT prides itself in being a thoughtful and practical partner to the world’s most innovative companies, helping them bring cutting-edge and often highly complex therapies to patients. Being one of the manufacturing sites for the world’s first therapy using the Nobel Prize winning technology, CRISPR, is another example of this skillset.”