Microbial contamination of hematopoietic progenitor cell products

Namdaroğlu, Sinem; Tekgündüz, Emre; Bozdağ, Sinem Civriz; Durgun, Gamze; Sarıca, Abdurrahman; Demiriz, Itır Şirinoğlu; Koçubaba, Şerife; İskender, Gülşen; Kayıkçı, Ömür; Altuntaş, Fevzi

doi:10.1016/j.transci.2013.04.026

Cited by 17 publications

(9 citation statements)

References 12 publications

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“…This fact highlights the importance of proper microbiologic analysis as an important part of quality control (QC) of PBSCs. The incidence of microbial contamination of stem cell products has been described in frequencies varying from close to 1% up to a contamination rate of 18% . The source of the graft has an impact on the contamination rate, which was highest in cord blood (15%), followed by marrow (4.5%) and PBSCs (3.9%) .…”

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confidence: 99%

Sterility release testing of peripheral blood stem cells for transplantation: impact of culture bottles and incubation temperature

et al. 2018

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BACKGROUND Sterility testing of peripheral blood stem cells (PBSCs) is mandatory before release. As antibiotic treatment of the PBSC donor may result in false‐negative results, PBSC matrix validation must be carried out. STUDY DESIGN AND METHODS Three spiked PBSCs and a buffy coat (BC; control matrix) were analyzed using the blood culture device BacT/ALERT 3D with the low‐temperature module. Samples were spiked with Staphylococcus aureus, Bacillus subtilis, Pseudomonas aeruginosa, Candida albicans, Aspergillus brasiliensis, Clostridium sporogenes, and Propionibacterium acnes. Standard iAST/iNST culture bottles and iFA/iFN Plus bottles, which include resorbing polymers, were incubated for 14 days. All aerobic bottles were incubated at 22.5°C and for a direct comparison also at 35°C while all anaerobic bottles were incubated at 35°C. RESULTS The BacT/ALERT 3D system detected all microbes in iAST/iNST culture bottles according to their growth behavior in the BC matrix. Detection of microbes differed significantly in PBSC products using standard iAST/iNST culture bottles and iFA/iFN Plus bottles with resorbing polymers: In Graft 1 no growth was detected in spiked bottles with S. aureus (iAST), B. subtilis (iAST/iNST), C. sporogenes (iNST), and P. acnes (iNST) compared to iFA Plus and iFN Plus bottles wherein growth of spiked microbes was confirmed. Graft 2, with another antibiotic treatment, showed no growth in iAST/iNST bottles spiked with P. aeruginosa, B. subtilis, and C. sporogenes. However, using iFA/iFN Plus bottles all spiked microbes were detectable. The comparison of incubation temperature showed an expected slower growth at 22.5°C. CONCLUSION The use of iFA/iFN Plus culture bottles incubated at different temperatures safely detected microbes in spiked PBSCs.

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confidence: 99%

Sterility release testing of peripheral blood stem cells for transplantation: impact of culture bottles and incubation temperature

et al. 2018

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“…Literature data report that the contamination rate for all products varies from 0.2% to as much as 26.3% [1,5,8,16,17]. It is even higher for CB products; the percentage amounts up to 48% [18].…”

Section: Discussionmentioning

confidence: 96%

“…Staphylococcus epidermidis was detected in 61.36% of all collected samples [17,21,22]. Microorganisms found in BM products differed from those in PBSC products.…”

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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“…In general, the addition of cell suspensions to culture media inevitably causes them to become opaque so that these methods are as a rule not recommendable for microbiological control of cellular products. Taking into account these limitations of classical methods, the European Pharmacopoeia Commission and others introduced the use of automatic culturing for microbiological control of cellular products which is currently widely used for the detection of micro‐organisms in cellular therapeutics . The advantage of the automated culture system is the shortened incubation period of 7 days.…”

Section: Concepts Of Microbial Safetymentioning

confidence: 99%

Microbial safety of cellular therapeutics—lessons from over ten years’ experience in microbial safety of platelet concentrates

Störmer

Wood

Gathof

2018

ISBT Science Series

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Bacterial safety of cellular preparations, including blood products and cellular therapeutics, presents ongoing challenges for physicians, manufacturers and regulators. Although there have been many new approaches to enhance the microbial safety of cellular products during the last decade, established methods for microbiological control still need to be fully adapted to the special circumstances of cellular preparations. The experience from transfusion medicine regarding microbial safety of blood components has demonstrated the variety of problems and risk factors for the development of new strategies for microbial safety. Special attention has been given to the prevention and detection of bacterial contamination of platelet concentrates. But so far, none of the targeted strategies for rapid detection or pathogen reduction have become routinely implemented worldwide, in part at least because development and requirements of new technologies and their implementation into the routine setting are a whole different problem. But factors including the short shelf life and nontraditional lot sizes for cellular and gene therapy products are driving the need for rapid microbiological methods. In conclusion, lessons from the microbial safety of platelet concentrates enable us to understand that the detection or reduction in bacteria represents a more difficult challenge in comparison with viruses. Recent regulatory changes demonstrate that we are getting closer to the goal of a shift from the traditional view of sterility evaluation (identify and inactivate anything and everything) to a new thinking about microbiological control.

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Microbial contamination of hematopoietic progenitor cell products

Cited by 17 publications

References 12 publications

Sterility release testing of peripheral blood stem cells for transplantation: impact of culture bottles and incubation temperature

Sterility release testing of peripheral blood stem cells for transplantation: impact of culture bottles and incubation temperature

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

Microbial safety of cellular therapeutics—lessons from over ten years’ experience in microbial safety of platelet concentrates

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