“Quality assurance is the responsibility of every Cellevate employee,” says Annika Andersson in charge of QA/RA at Cellevate. “Our mission has been from the start to bring to market cutting-edge, state-of-the-art products that truly meet the needs of our customers. In earning this certification, we are driven to not only adhere to our already high-quality assurance standards, but to continually improve upon them.”

Completed and validated a new cleanroom at its facility in Lund

In parallel with achieving ISO 9001 certification, Cellevate has completed and validated a new cleanroom at its facility in Lund. The cleanroom is dedicated to the production of the company’s commercial portfolio, Cellevat3d nanofiber products, supporting the increasing demand from global distributors, biopharmaceutical companies, and CDMOs.

“Securing ISO 9001 certification is more than a quality milestone. It reflects our commitment to operational excellence and to supporting our customers with the highest level of reliability as we scale and intensify commercial operations,” says Laura Chirica, CEO at Cellevate. “Combined with the new cleanroom, we now have a robust and scalable foundation for expanding manufacturing capacity and implementing GMP-ready processes for commercial volumes. These new advancements strengthen Cellevate’s position as a trusted partner and supplier to customers and collaborators across the biopharmaceutical and bioprocessing industry.”