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050 Meeting medical device standards with a closed system cryogenic Vial for Cellular Therapy Products

Fearnot, Evonne R, Thirumala, Sreedhar, Woods, Erik J
Cryobiology 2013 v.67 no.3 pp. 411-412
bags, blood, closed loop systems, compliance, cryopreservation, cryoprotectants, dimethyl sulfoxide, durability, dyes, freezing, good manufacturing practices, hematopoietic stem cells, humans, manufacturing, packaging, shelf life, temperature, therapeutics, transportation, umbilical cord, viability
The use of closed systems for low volume processing and storage of cell therapy products is necessary for good manufacturing practices (GMP), yet compliance with medical device regulatory test standards is lacking. A sterile closed system vial (CellSeal® cryogenic vial, Cook General BioTechnology, LLC, IN, USA) that meets pharmaceutical quality requirements was evaluated to determine if the vial also meets medical device standards for storage of cellular therapy products at cryogenic temperatures. The post-sterile stability and shelf-life of the device was evaluated by subjecting the device packaging to hazardous situations (manufacturing, transportation, distribution, and aging) typically undergone prior to usage. The packaging was exposed to simulated dynamic environmental conditioning, and separately to aging conditions equal to 36 real-time months. Subsequent to both dynamic environmental conditioning and aging, a series of product tests were completed to determine if the device maintained sterility and strength/integrity throughout the hazardous environments. Also, the device was evaluated to address necessary related and potential biological and toxicological hazards associated with the device intended use. Additionally, the loaded, sealed, and frozen device was tested for durability and integrity utilizing a 1-meter drop test. In addition, these were transported and tested using pharmaceutical packaging tests including dye ingress and microbial challenge. Further, human umbilical cord blood hematopoietic progenitor cells (UCB) from 3 donors were used to establish the performance of the vials after 1-month of storage. For each donor, a 30ml concentrated UCB was prepared after adding 10% dimethyl sulfoxide as cryoprotectant. Next, 10ml of this was cryopreserved using 2×5ml vials with the remaining 20ml cryopreserved in standard FDA-cleared Pall® Medical cord blood freezing bags as a control. For both CellSeal vials and bags, an integral test segment was retained. All samples were analyzed for total nucleated cell count, colony-forming unit (CFU) assay and viability using 7-AAD. This study confirms that the CellSeal cryogenic vial meets medical device testing standards for low volume cryopreservation of clinical cell therapy products.Source of funding: Cook General BioTechnology, LLC, 1102 Indiana Avenue, Indianapolis, IN, USAConflict of interest: None