053 Manufacturing and Cryopreservation of Endometrial Regenerative Cells (ERC) for Clinical Therapies: Ensuring Product Safety and Quality

Abstract

Endometrial Regenerative Cells (ERC) isolated from menstrual blood of healthy volunteers have been shown to possess a higher regenerative ability, and distinct growth factor profile compared to other tissue derived MSCs. The ability to expand ERC for >68 doublings without detection of karyotypic abnormalities supports the feasibility of using this population for therapeutic development. We recently have achieved manufacturing, scale-up and banking of ERC by adopting current good manufacturing practices (cGMP)-compliant procedures and developed a safe and effective off-the-shelf (allogeneic) product for clinical applications. This was accomplished by a large-scale expansion and cryopreservation of ERCs from a single qualified donor. A master cell bank (MCB) was set-up to manufacture and bank a massive number of ERC required for a therapeutic dose in a safe and cost-effective method. ERC were processed using cGMP qualified reagents and cryopreserved in a closed system cryogenic container (CellSeal® vials). CellSeal® vials permitted the banking of ERC in the liquid phase of LN2, ensuring no concerns regarding contamination and unfavorable temperature gradients. The shipping of cryopreserved therapeutic doses over continental US and international destinations under safety and regulatory guidelines preserved the core therapeutic properties of ERC and indicated a valuable allogeneic product for clinical transplant or transfusion applications. Source of funding: None declared. Conflict of interest: None declared. [email protected]