Seraxis, an American regenerative medicine company, has announced the completion of a comprehensive third party on site GMP audit of its QMS cleanroom, cell growing production process and QC laboratory.
Seraxis is developing a pancreatic islet replacement therapy to transform the lives of patients with Type 1 and insulin-requiring Type 2 diabetes.
The audit was conducted in advance of Seraxis's planned IND submission of the pancreatic clusters candidate SR-02 for the intended treatment of insulin-dependent diabetes.
The third-party auditor's FDA six-system approach yielded no critical nor major observations of Seraxis' quality system for the production of GMP-grade organs from pancreas-derived stem cells
The independent audit followed the FDA six-system approach and concluded that Seraxis's proprietary manufacturing process is in compliance with GMP audit standards, regulations and internal written procedures, putting SR-02 on track to be the industry's second clinical-stage stem cell derived pancreatic islet transplant programme.
The third-party auditor's FDA six-system approach yielded no critical nor major observations of Seraxis' quality system for the production of GMP-grade organs from pancreas-derived stem cells.
CEO of Seraxis, William Rust, said: “Seraxis' stem cell line SR1423 was derived from pancreatic cells and retains the epigenetic fingerprint of islets so, by design, they efficiently expand and generate replacement islet clusters. This characteristic eliminates purification steps, enabling Seraxis to manufacture product on a clinical scale for both the SR-02 programme and the follow-on immune-cloaked SR-03 programme in our Germantown facility.”
Seraxis Chief Operating Officer, Carole Welsch, said: "The manufacturing of an exquisite cluster of living cells - essentially the production of a replacement human organ - is a tremendously nuanced and intricate feat of biological engineering. We are proud that our team has created a clinical-scale cleanroom production facility and quality system that pass muster with a rigorous audit comparable to a possible future FDA inspection associated with our upcoming IND filings.”
