In a significant leap forward for the biotechnology industry, SmartCella, through its business unit ProCella, has recently secured approval from the Swedish Medicinal Product Agency for the manufacturing and quality control testing of sterile biological medicinal products for cell therapy.
This landmark achievement underscores SmartCella’s commitment to advancing the field of cell-based therapies and marks a pivotal moment in the company’s journey towards revolutionizing medical treatments.
A Milestone in GMP Certification
The approval encompasses both manufacturing authorization and Good Manufacturing Practice (GMP) certification, enabling SmartCella to commence clinical production of cell-based therapies for clinical studies.
Located at SmartCella’s headquarters in Tullinge, near the Karolinska University Hospital outside of Stockholm, the facility is poised to support both internal therapeutic developments and third-party manufacturing for pre-clinical and clinical development phases.
Alden Kandic, Head of Quality and Qualified Person at ProCella, expressed immense pride in achieving this milestone. The state-of-the-art GMP facility, featuring two large grade B cleanrooms and one grade C and D room, was constructed in 2022.
Over the past year, the team has undertaken extensive validation activities for both the facility and its equipment, alongside implementing a robust quality system for the manufacture of Advanced Therapy Medicinal Products (ATMP) for clinical trials.
The successful completion of the authority inspection marks a grand finale to these efforts.
SmartCella’s Comprehensive Approach to Cell Therapy
Niklas Prager, CEO of SmartCella, highlighted the approval of the GMP facility as a key milestone for the company. SmartCella now boasts capabilities spanning the entire product development lifecycle, from early research and development within SmartCella Solutions to proof of concept in ProCella.
This comprehensive approach, combined with a stellar quality control system, positions SmartCella uniquely in the market, offering a competitive advantage for future cell therapy product development.
Moreover, SmartCella has launched the Extroducer, one of the most advanced endovascular delivery devices. This innovation enables the delivery of a wide range of therapeutic agents directly into organs and tumors, further establishing SmartCella as a comprehensive provider for targeted therapies.
About SmartCella Holding AB
Founded in 2014, SmartCella is an innovative biotechnology company based in Stockholm, Sweden. With a vision to combine first-in-class delivery platforms with cutting-edge cell and gene therapies, SmartCella aims to unleash the full potential of targeted therapies.
The company operates through three main business units: Smartwise, SmartCella Solutions, and ProCella, each contributing uniquely to the advancement of medical science and treatment.
SmartCella’s recent GMP certification and manufacturing approval represent a significant step forward in the field of cell therapy. As the company continues to develop and manufacture innovative therapies, its contributions are expected to have a profound impact on the treatment of various diseases, paving the way for new and more effective medical treatments.
For more information about SmartCella and its pioneering work in biotechnology, visit www.smartcella.com.