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

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

doi:10.1111/j.1537-2995.2007.01232.x

Cited by 3 publications

(5 citation statements)

References 13 publications

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“…Indeed, it has been previously reported that the amount of viable transplanted CD341 cells measured after thaw does not improve prediction of engraftment kinetics compared to the total CD341 cell dose measured prefreeze. 4 Viability observed in the unselected CD451 cell population was lower compared to CD341 PBSCs, which is presumably caused by the content of granulocytes known to be highly sensitive to ex vivo apoptotic cell death as previously described. 7 However, as these cells are not critical for hematopoietic engraftment, the reduced viability of these cells may be negligible.…”

Section: Discussionmentioning

confidence: 69%

“…Recovery rate of CD34+ PBSC after thawing was not routinely analyzed as many factors may influence this analysis not corresponding to the direct transfer of cells from the cryobags during transplantation. Indeed, it has been previously reported that the amount of viable transplanted CD34+ cells measured after thaw does not improve prediction of engraftment kinetics compared to the total CD34+ cell dose measured prefreeze . Viability observed in the unselected CD45+ cell population was lower compared to CD34+ PBSCs, which is presumably caused by the content of granulocytes known to be highly sensitive to ex vivo apoptotic cell death as previously described .…”

Section: Discussionmentioning

confidence: 87%

“…The addition of DMSO as cytoprotectant is the only critical step and has historically been performed without a clean‐room facility, as it is still the case outside of Europe. Closed‐bag systems for cryopreservation of peripheral blood progenitor cells have been previously proposed and tested using buffy coats and leukapheresis products of healthy donors . However, no data regarding clinical application is available.…”

Section: Discussionmentioning

confidence: 99%

“…Closed-bag systems for cryopreservation of peripheral blood progenitor cells have been previously proposed and tested using buffy coats and leukapheresis products of healthy donors. 4 However, no data regarding clinical application is available. We have established and validated a simple, cost-saving, and effective cryopreservation process and demonstrate here that stem cell products manufactured by this technique have high cell viabilities and low contamination rates when compared to those manufactured within clean rooms.…”

Section: Discussionmentioning

confidence: 99%

See 3 more Smart Citations

Long‐term experiences in cryopreservation of mobilized peripheral blood stem cells using a closed‐bag system: a technology with potential for broader application

et al. 2015

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Section: Discussionmentioning

confidence: 69%

Section: Discussionmentioning

confidence: 87%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

Long‐term experiences in cryopreservation of mobilized peripheral blood stem cells using a closed‐bag system: a technology with potential for broader application

et al. 2015

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“…to Good Manufacturing Practice (GMP). Alternatively, the processing may take place in a closed system which reduces high maintenance costs of such clean rooms [24,25].…”

Section: Discussionmentioning

confidence: 99%

Microbial contamination risk in hematopoietic stem cell products: retrospective analysis of 1996–2016 data

Antoniewicz‐Papis

Lachert

Rosiek

et al. 2020

Acta Haematologica Polonica

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Quality assurance and safety of hematopoietic stem cells (HSC) with special emphasis on bacterial and fungal contamination is the prerequisite for any transplantation procedure. The aim was to determine the incidence rate of such contamination during processing of transplantation material with regard to HSC source: peripheral blood stem cell (PBSC), bone marrow (BM), or cord blood (CB). Analysis involved autologous and allogenic products dedicated for patients and comprised in all 4135 donations, including 112 BM (2.70%), 3787 PBSC (91.60%), and 236 CB (5.70%) processed in cell bank over the period 1996–2016. Aerobic and anaerobic contamination was determined.Analysis of the 20-year data revealed 42 contaminated products: 25 PBSC (0.66% of tested units) and 17 CB (7.20% of tested units). No microbial contamination of BM products was detected. Overall percentage of contaminated products was 1.01%, mostly with Staphylococcus epidermidis (61.36%). Bacterial contamination rate at cell bank is relatively low and processing in a closed system does not seem as crucial as might be expected. This is particularly true for BM components. Equally important are evaluation of donor’s medical status and condition of the puncture site for collection of source material. Implementation of appropriate sample collection procedures should help minimize the risk of false-positive results due to environmental contamination.

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Cryopreservation in Closed Bag Systems as an Alternative to Clean Rooms for Preparations of Peripheral Blood Stem Cells

Spoerl

Peter

Krackhardt

2016

Advances in Experimental Medicine and Biology

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Autologous and allogeneic stem cell transplantation (SCT) represents a therapeutic option widely used for hematopoietic malignancies. One important milestone in the development of this treatment strategy was the development of effective cryopreservation technologies resulting in a high quality with respect to cell viability as well as lack of contamination of the graft.Stem cell preparations have been initially performed within standard laboratories as it is routinely still the case in many countries. With the emergence of cleanrooms, manufacturing of stem cell preparations within these facilities has become a new standard mandatory in Europe. However, due to high costs and laborious procedures, novel developments recently emerged using closed bag systems as reliable alternatives to conventional cleanrooms. Several hurdles needed to be overcome including the addition of the cryoprotectant dimethylsulfoxide (DMSO) as a relevant manipulation. As a result of the development, closed bag systems proved to be comparable in terms of product quality and patient outcome to cleanroom products. They also comply with the strict regulations of good manufacturing practice.With closed systems being available, costs and efforts of a cleanroom facility may be substantially reduced in the future. The process can be easily extended for other cell preparations requiring minor modifications as donor lymphocyte preparations. Moreover, novel developments may provide solutions for the production of advanced-therapy medicinal products in closed systems.

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

Abstract: 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.

Cited by 3 publications

References 13 publications

Long‐term experiences in cryopreservation of mobilized peripheral blood stem cells using a closed‐bag system: a technology with potential for broader application

Long‐term experiences in cryopreservation of mobilized peripheral blood stem cells using a closed‐bag system: a technology with potential for broader application

Microbial contamination risk in hematopoietic stem cell products: retrospective analysis of 1996–2016 data

Cryopreservation in Closed Bag Systems as an Alternative to Clean Rooms for Preparations of Peripheral Blood Stem Cells

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