Seraxis’ Manufacturing Suite Completes GMP Quality System Audit Ahead of SR-02 IND Filing and Transplantation of Pancreatic Clusters to Patients With Type 1 Diabetes
GMP-compliant manufacturing puts SR-02 on track to be industry’s second clinical-stage stem cell derived pancreatic islet transplant program.
The third-party auditor’s FDA six-system approach yielded no critical nor m…