Solvias, a global provider of chemistry, manufacturing, and control (CMC) analytics, entered a long-term agreement with Vertex Pharmaceuticals to perform analytical release testing services on the first CRISPR/Cas9 genome-edited cell therapy, CASGEVY. 
 
CASGEVY (exagamglogene autotemcel or exa-cel) received FDA approval for the treatment of sickle cell disease (SCD) in patients 12 years and older with recurrent vaso-occlusive crises.
 
The companies have worked together for several years to develop and validate test methods that are critical for the final release of patients’ own edited cells, so that they can be delivered back to patients. The collaboration included establishing the testing methods that will be scaled for commercializing CASGEVY. Solvias also has invested significantly in preparing one of its global facilities to support the commercial release work for this transformative therapy.
 
Archie Cullen, Chief Executive Officer, Solvias, said, “Solvias is honored to be playing a critical role in delivering this breakthrough therapy to patients. Our decades of experience offering comprehensive GMP analytical services uniquely positions us to partner with companies in bringing their therapies to market. This collaboration highlights our deep scientific knowledge and creative solutions serving to advance even the most cutting-edge therapies.”
 
CASGEVY also recently received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use for conditional approval of the treatment of severe SCD and transfusion-dependent beta thalassemia (TDT).