ProCella, a business unit of SmartCella, has received manufacturing authorization and Good Manufacturing Practice (GMP) certification from the Swedish Medicinal Product Agency. This milestone allows ProCella to commence clinical production of cell-based therapies for clinical studies.

Located at SmartCella's headquarters near Karolinska University Hospital in Tullinge, Sweden, the facility boasts world-class GMP standards. With two large grade B cleanrooms and additional grade C and D rooms, the 300 square meter facility is equipped for both internal therapeutic developments and third-party manufacturing services for pre-clinical and clinical development phases.

Alden Kandic, Head of Quality and Qualified Person at ProCella, said, "We are immensely proud of this important milestone. This world-class GMP facility will enable us to manufacture according to cGMP for clinical studies. The 300 square meter facility, built in 2022, consists of two large grade B cleanrooms, and one grade C and D room, respectively. Over the last year, the team conducted comprehensive validation activities of both the facility and equipment. Furthermore, we have implemented a solid quality system underpinning the manufacture of Advanced Therapy Medicinal Products (ATMP) for clinical trials. This has been a true team effort, and everyone has been fully dedicated ensuring a successful completion. The grand finale was the authority inspection, and we couldn't be happier with the positive outcome."

Niklas Prager, CEO of SmartCella, said, "The approval of our GMP facility is a key milestone for SmartCella. We now have capabilities across the entire life cycle of product development, from early Research and Development within SmartCella Solutions to proof of concept in ProCella, with all relevant process development and subsequent technology transfer to production. This, in combination with a stellar quality control system, makes us unique and we have a competitive advantage for future cell therapy product development. Lastly, we have also launched one of the most advanced endovascular delivery devices, the Extroducer, that enables the delivery of a wide range of therapeutic agents directly into organs and tumors, thus making SmartCella a truly comprehensive provider for targeted therapies."