Thursday, February 08, 2024
SmartCella's subsidiary, ProCella, has received approval from the Swedish Medicinal Product Agency for the manufacturing and quality control testing of sterile biological medicinal products for cell therapy.
ProCella, operating under SmartCella, is delighted to announce its acquisition of manufacturing authorization and Good Manufacturing Practice (GMP) certification from the Swedish Medicinal Product Agency. These approvals mark the commencement of clinical production for cell-based therapies, paving the way for clinical studies. The facility, situated at SmartCella's headquarters in Tullinge near Karolinska University Hospital outside Stockholm, will serve both internal therapeutic developments and third-party manufacturing for pre-clinical and clinical development phases.
Alden Kandic, ProCella's Head of Quality and Qualified Person, expressed immense pride in reaching this significant milestone. The state-of-the-art GMP facility spans 300 square meters, featuring two sizable grade B cleanrooms and one each of grade C and D rooms. Over the past year, the team diligently conducted comprehensive validation activities for the facility and equipment. Moreover, they established a robust quality system to support the manufacturing of Advanced Therapy Medicinal Products (ATMP) for clinical trials. Kandic acknowledged the collective effort of the team, emphasizing their dedication to ensuring a successful completion, culminating in a positive outcome during the authority inspection.
SmartCella, added, "The approval of our GMP facility marks a pivotal milestone for SmartCella." He highlighted the company's comprehensive capabilities throughout the product development lifecycle, ranging from early Research and Development within SmartCella Solutions to proof of concept in ProCella, encompassing process development and technology transfer to production. Prager underscored the company's competitive advantage in cell therapy product development, facilitated by a robust quality control system. Additionally, SmartCella recently introduced the Extroducer, an advanced endovascular delivery device facilitating the targeted delivery of therapeutic agents into organs and tumors, further solidifying SmartCella's position as a comprehensive provider for targeted therapies.