CDMO RoslinCT reports that it will manufacture the world’s first CRISPR-based therapy, exa-cel, across the world as part of the global manufacturing network for Vertex Pharmaceuticals. Exa-cel (brand name CasgevyTM) is a new treatment for sickle cell disease and transfusion-dependent beta thalassemia, authorized by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) on November 15. The MHRA granted RoslinCT a Manufacturer’s Authorization License (MIA) for commercial manufacturing of cell therapy products in March.
“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,” said Peter Coleman, CEO, RoslinCT U.K.
“RoslinCT has deep roots in stem cell technology and decades of expertise and excellence in process and cGMP capability making us a perfect partner to support a highly complex project like this. We feel privileged to be working alongside Vertex to bring this ground-breaking therapy to patients and are excited about the broader potential to deepen and enhance our skillset.”
“As the first country to authorize a CRISPR-based therapy and home to one of the key manufacturing sites, the U.K. is well positioned to lead on providing access to gene editing treatments,” added Steve Bates, CEO, U.K. Bioindustry Association.