White Paper: Comparability Of The Cell-Freeze® (Charter Medical) Freezing Bag To The Cryocyte™ (Baxter) Bag For Cryogenic Storage Of Human Hematopoietic Progenitor Cells

Successful cryopreservation of hematopoietic progenitor cells (HPC) is dependent upon a number of factors, including the biopreservation media, freezing rates, and storage using sterile, cryogenically durable storage bags. The Cell-Freeze® cryogenic storage containers are 510(k) cleared for storage, preservation and transfer of hematopoietic progenitor stem cells (HPC's). The Cell-Freeze® bags are made from a unique polyolefin film that offers excellent durability while remaining flexible when stored at ultra low temperatures (-196°C). In addition, the proprietary membrane port design offers thinner walls for increased flexibility while the industry standard label pocket design lends to ease of use and traceability for product labeling. The available interface tubing and connectors are compatible with sterile connection and smart seal technologies allowing for closed-system applications.

The aim of this study was to investigate the bioequivalence of the Cell-Freeze® (Charter Medical, Ltd. Winston-Salem, NC) freezing bag to the Cryocyte™ (Baxter Healthcare, Deerfield, IL) freezing bag. The Cell-Freeze® bags were designed to directly replace the now discontinued Cryocyte™ bags. The data shown here demonstrates that with regards to post-thaw recovery of human HPC's, the Cell- Freeze® cryogenic storage bags perform comparably to the Cryocyte bags.