Comparison of CryoMACS Freezing Bags with Maco Biotech Freezing-Ethinyl Vinyl Acetate Bags for Hematopoietic Progenitor Cells Cryopreservation Using a CD34+-Enriched Product.

Abstract

Background: Hematopoietic progenitor cells (HPCs) cryopreservation have applications, especially in the autologous setting, allowing therapeutic use several years after collection. Cryopreservation aims to preserve the therapeutic properties of HPCs, and successful cryopreservation depends on several factors such as preservation procedures, biopreservation media, freezing rates, and thawing procedures. In this context, the choice of the freezing bag is critical as it provides mechanical protection during the freezing process. Since Maco Biotech Freezing-ethinyl vinyl acetate (EVA) Bags^® are no longer available in our country, a comparative study was developed to verify bioequivalence with the Miltenyi CryoMACS^® freezing bag. Methods: In this study, a CD34⁺-enriched product was used to better reproduce HPC apheresis. Freezing bags were filled with the same volume, cryopreserved with controlled rate freezing, and stored in the vapor phase of liquid nitrogen for at least 6 months. After thawing, all bags were tested for integrity and sterility using a microbial challenge. In addition, a comparison was developed by evaluating recovery of white blood cells, mononuclear cells, lymphocytes, and CD34⁺ cells. Results: No significant differences between the two manufacturers' bags have been observed in terms of the evaluated parameters. Data were confirmed, even comparing bags according to filling volume. Data presented in this study support the conclusion that CryoMACS freezing bags are bioequivalent to Maco Biotech Freezing-EVA Bags for HPC cryopreservation.