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Humpe, Andreas; Jansen, Pal; Tischer, Bernd Karsten; Schubert, Sabine; Beck, Christian; Adamzik, Ilse‐Dorothea; Maas, Jens‐Holger; Strate, Alexander; Gramatzki, Martin; Riggert, Joachim

Cryopreservation of cellular products in a closed‐bag system with an incorporated dimethyl sulfoxide–resistant sterile filter outside of cleanroom facilities

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  • Medientyp: E-Artikel
  • Titel: Cryopreservation of cellular products in a closed‐bag system with an incorporated dimethyl sulfoxide–resistant sterile filter outside of cleanroom facilities
  • Beteiligte: Humpe, Andreas; Jansen, Pal; Tischer, Bernd Karsten; Schubert, Sabine; Beck, Christian; Adamzik, Ilse‐Dorothea; Maas, Jens‐Holger; Strate, Alexander; Gramatzki, Martin; Riggert, Joachim
  • Erschienen: Wiley, 2007
  • Erschienen in: Transfusion
  • Sprache: Englisch
  • DOI: 10.1111/j.1537-2995.2007.01232.x
  • ISSN: 0041-1132; 1537-2995
  • Schlagwörter: Hematology ; Immunology ; Immunology and Allergy
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:p><jats:bold>BACKGROUND:</jats:bold> Manipulations, for example, cryopreservation, of cellular therapeutics carried out in an open system must be performed in a class A environment with surrounding class B environment. To avoid cleanroom facilities, a new closed‐bag system with an incorporated dimethyl sulfoxide–resistant sterile filter for cryopreservation of cellular products was evaluated at two different centers.</jats:p><jats:p><jats:bold>STUDY DESIGN AND METHODS:</jats:bold> A total of 44 different products (22 buffy coats [BCs] and 22 leukapheresis [LK] products) were split and cryopreserved in parallel in cleanroom facilities (Method I) and with the closed system on the bench of a “normal” laboratory (Method II). Viability analyzed by 7‐aminoactinomycin D staining and flow cytometric analysis and sterility of the products were analyzed.</jats:p><jats:p><jats:bold>RESULTS:</jats:bold> Independent of the cellular source (BC or LK), the median viability of CD45+ cells decreased significantly (p  &lt; 0.01) during cryopreservation: namely, in BCs, −15.8 percent with both methods, and in LK products, −5.4 percent with Method I and −4.8 percent with Method II, respectively. CD3+ as well as CD14+ cells exhibited a similar pattern and were also found significantly (p  &lt; 0.01) diminished after thawing independent of the handling system. For CD19+ cells, the small decrease of viability was only for the BC group significant (p = 0.027) when the cells had been processed with Method I. No bacterial contamination was detected neither in fresh products nor in products after cryopreservation.</jats:p><jats:p><jats:bold>CONCLUSION:</jats:bold> The closed system for cryopreservation of cellular products appears to be equivalent to cleanroom‐based methods regarding cellular integrity and sterility when appropriate quality of sterile filters is assured.</jats:p>