🧪 Solvias has signed a long-term agreement with Vertex Pharmaceuticals for CASGEVY.
💊 CASGEVY has received FDA approval for treating sickle cell disease in patients 12 years and older.
🔬 Solvias has worked with Vertex for years to develop and validate test methods for patient-specific cell therapy.
✅ CASGEVY has also received a positive opinion from the EMA for conditional approval to treat severe SCD and TDT. 🌍Solvia’s global facilities are prepared for commercial release work.
Introduction:
Solvias, a pharmaceutical testing and development company, has signed a long-term agreement with Vertex Pharmaceuticals to perform analytical release testing services on CASGEVY, the world’s first CRISPR/Cas9 genome-edited cell therapy. CASGEVY has received FDA approval for the treatment of sickle cell disease and has also received a positive opinion from the European Medicines Agency for conditional approval for the treatment of severe sickle cell disease and transfusion-dependent beta thalassemia. Solvias has worked with Vertex to develop and validate test methods for the final release of patients’ own edited cells, which are then delivered back to patients.
- Solvias will perform analytical release testing services on CASGEVY, the first CRISPR/Cas9 genome-edited cell therapy
- Vertex Pharmaceuticals has collaborated with Solvias to develop and validate test methods for the final release of patients’ own edited cells
- CASGEVY has received FDA approval for the treatment of sickle cell disease and a positive opinion from the European Medicines Agency for the treatment of severe sickle cell disease and transfusion-dependent beta thalassemia
Conclusion:
Solvias and Vertex Pharmaceuticals have entered into a long-term agreement for Solvias to perform analytical release testing services on CASGEVY, the world’s first CRISPR/Cas9 genome-edited cell therapy. This therapy has received regulatory approvals for the treatment of sickle cell disease and shows potential for the treatment of other genetic diseases. The collaboration between Solvias and Vertex highlights the importance of reliable and validated test methods in the development and commercialization of innovative cell therapies. The successful launch of CASGEVY could pave the way for future advancements in the field of genetic therapeutics.
