Thawing cryopreserved apheresis products: comparison of barkey plasmatherm dry heating device and 37oC water bath

Abstract

Background & Aim The Barkey Plasmatherm (Barkey GmbH & Co. KG) dry heating device (BPDHD) is designed to thaw frozen products intended for infusion. This study compared cryopreserved apheresis hematopoietic stem/progenitor cell (HS/PC) product CD34 + cell dose recovery, viability and sterility using the BPDHD and a traditional 37°C water bath (Isotemp; Fisher Scientific). Methods, Results & Conclusion METHODS Cryopreserved HS/PC apheresis products were used to assess CD34 recovery, viability and sterility. We selected two products from a single processing and freezing from three independent collections. A paired bag from each of the three collections and freezing procedures was thawed using either the BPDRD or Isotemp water bath. Each thawed product was tested for CD34+ cell dose recovery, CD34+ cell 7AAD viability, sterility by bacterial culture, and colony forming unit (CFU) growth (Stem Cell Technologies). We also performed an independent 3-month post-transplant follow up to compare the time to neutrophil and platelet engraftment in patients who received products thawed using the BPDHD vs products thawed using the Isotemp water bath RESULTS Three products were thawed using BPDHD and 3 products were thawed using a water bath for a total of 6 products thawed and tested. Table 1 summarizes the post-thaw testing performed on each product. All post-thaw testing met our established release criteria (Table 2). We compared the engraftment outcomes for the first 15 patients who received products thawed with the BPDHD to transplant recipients who received products thawed in the Isotemp water bath. We evaluated days to > 500 neutrophils/uL for three consecutive days, and days to platelet count > 20 × 109/L without platelet transfusion support for 7 days. We found no difference between the two thawing methods (Table 3.) CONCLUSION A 37oC water bath is the most commonly used device to thaw cellular therapy products in the United States. This method requires manually submerging the product directly into temperature-controlled water and massaging the bag to ensure a complete thaw, and the water must be changed after each use. The BPDHD is a dry heating system with water-filled cushions and the water is changed annually. Moreover, the water never touches the product, which in principle will reduce the possibility of contamination. The BPDHD takes away the manual manipulation of the product making thawing more standardized, which may translate into improved laboratory efficiency. The Barkey Plasmatherm (Barkey GmbH & Co. KG) dry heating device (BPDHD) is designed to thaw frozen products intended for infusion. This study compared cryopreserved apheresis hematopoietic stem/progenitor cell (HS/PC) product CD34 + cell dose recovery, viability and sterility using the BPDHD and a traditional 37°C water bath (Isotemp; Fisher Scientific). Cryopreserved HS/PC apheresis products were used to assess CD34 recovery, viability and sterility. We selected two products from a single processing and freezing from three independent collections. A paired bag from each of the three collections and freezing procedures was thawed using either the BPDRD or Isotemp water bath. Each thawed product was tested for CD34+ cell dose recovery, CD34+ cell 7AAD viability, sterility by bacterial culture, and colony forming unit (CFU) growth (Stem Cell Technologies). We also performed an independent 3-month post-transplant follow up to compare the time to neutrophil and platelet engraftment in patients who received products thawed using the BPDHD vs products thawed using the Isotemp water bath