GMP Compliant Production of a Cryopreserved Adipose-Derived Stromal Cell Product for Feasible and Allogeneic Clinical Use

• Published in: Stem cells international Vol. 2022; pp. 1 - 12
• Main Authors: Haack-Sørensen, Mandana, Johansen, Ellen Mønsted, Højgaard, Lisbeth Drozd, Kastrup, Jens, Ekblond, Annette
• Format: Journal Article
• Language: English
• Published: New York Hindawi 20-06-2022; John Wiley & Sons, Inc; Hindawi Limited
• Subjects: Abdomen; Automation; Blood banks; Body fat; Cardiology; Clinical trials; Control methods; Cryopreservation; Feasibility; Good Manufacturing Practice; Hepatitis B; Hospitals; Infectious diseases; Laboratories; Liposuction; Manufacturing; Manufacturing industry; Patient safety; Product design; Product introduction; Quality control; Raw materials; Risk assessment; Serology; Stem cells; Stromal cells; Supply chains; Syphilis; Denmark
• ISSN: 1687-966X; 1687-9678; 1687-9678
• DOI: 10.1155/2022/4664917

The emerging field of advanced therapy medicinal products (ATMP) holds promise of treating a variety of diseases. Adipose-derived stromal cells (ASCs) are currently being marketed or tested as cell-based therapies in numerous clinical trials. To ensure safety and efficacy of treatments, high-quality products must be manufactured. A good manufacturing practice (GMP) compliant and consistent manufacturing process including validated quality control methods is critical. Product design and formulation are equally important to ensure clinical feasibility. Here, we present a GMP-compliant, xeno-free, and semiautomated manufacturing process and quality controls, used for large-scale production of a cryopreserved off-the-shelf ASC product and tested in several phase I and II allogeneic clinical applications.