Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2011 Jun;51(6):1291-5.
doi: 10.1111/j.1537-2995.2010.02994.x. Epub 2010 Dec 22.

A validation study of new cryopreservation bags for implementation in a blood and marrow transplant laboratory

Gregory J Pomper  1 , Emily Wilson, Scott Isom, David D Hurd
Affiliations

A validation study of new cryopreservation bags for implementation in a blood and marrow transplant laboratory

Gregory J Pomper et al. Transfusion. 2011 Jun.

Abstract

Background: A new cryopreservation bag for hematopoietic cell transplantation requires validation as a safe alternative to the bag currently being used in the laboratory.

Study design and methods: The new bag was validated using both laboratory and clinical criteria. Laboratory validation proceeded using paired samples of mononuclear cells processed using standard procedures. Cells cryopreserved in the new and old bags were compared for viability, cell counts, CD34 enumeration, colony-forming unit assays, and bag integrity. After completion of laboratory investigations, engraftment with the new bags was followed and compared to historical engraftment using the old bags.

Results: There were no significant differences between the old and new bags detected using laboratory studies. Bag integrity was equivalent. The validation data suggested impaired cell function after cryopreservation in the new bags, but there were no significant differences in engraftment potential using either material. Days to engraftment was longer using the new bags, but statistical analysis revealed an association with CD34 dose and not with cryopreservation bag type.

Conclusion: The new bags were noninferior to the old bags. A change in cryopreservation bag type may appear to affect cell function and potentially affect engraftment. Multiple analyses may be needed to understand the effect of cell processing changes.

PubMed Disclaimer

Conflict of interest statement

CONFLICT OF INTEREST

There are no conflicts of interest reported by any of the authors.

Figures

Fig. 1
Fig. 1
Days to engraftment for patients receiving autologous PBPCs cryopreserved in old and new bags. (—) New bag; (----) old bag.
See this image and copyright information in PMC

References

    1. FACT-JACIE. International standards for cellular therapy product collection, processing and administration. 4. 2008.
    1. Food and Drug Administration. Current good tissue practices. 21CFR1271.150.
    1. Food and Drug Administration. Guideline on general principles of process validation. 1987 [cited 2010 Nov 29]. Available from: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidanc....
    1. Stewart DA, Guo D, Luider J, Auer I, Klassen J, Ching E, Morris D, Chaudhry A, Brown C, Russell JA. Factors predicting engraftment of autologous blood stem cells: CD34+ subsets inferior to the total CD34+ cell dose. Bone Marrow Transplant. 1999;23:1237–43. - PubMed
    1. Proctor J, Regen D. Validation of cryobags. ISCT Telegraft. 2006;13:8–10.

MeSH terms

LinkOut - more resources