Validation of shortened 2-day sterility testing of mesenchymal
stem cell-based therapeutic preparation on an automated culture
system

J 2016

Validation of shortened 2-day sterility testing of mesenchymal stem cell-based therapeutic preparation on an automated culture system

LYSAK, D., M. HOLUBOVA, T. BERGEROVA, M. VAVROVA, G. C. CANGEMI et. al.

Základní údaje

Originální název

Validation of shortened 2-day sterility testing of mesenchymal stem cell-based therapeutic preparation on an automated culture system

Autoři

LYSAK, D. (203 Česká republika), M. HOLUBOVA (203 Česká republika), T. BERGEROVA (203 Česká republika), M. VAVROVA (203 Česká republika), G. C. CANGEMI (380 Itálie), R. CICCOCIOPPO (380 Itálie), Peter KRUŽLIAK (703 Slovensko, garant, domácí) a P. JINDRA (203 Česká republika)

Vydání

Cell and Tissue Banking, Dordrecht, Springer, 2016, 1389-9333

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

10601 Cell biology

Stát vydavatele

Nizozemské království

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 1.331

Kód RIV

RIV/00216224:14110/16:00113811

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1007/s10561-015-9522-9

UT WoS

000372277400001

Klíčová slova anglicky

Automated culture system; Cell therapy; Mesenchymal stem cells; Sterility; Validation

Štítky

rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 27. 4. 2020 15:36, Mgr. Tereza Miškechová

Anotace

V originále

Cell therapy products represent a new trend of treatment in the field of immunotherapy and regenerative medicine. Their biological nature and multistep preparation procedure require the application of complex release criteria and quality control. Microbial contamination of cell therapy products is a potential source of morbidity in recipients. The automated blood culture systems are widely used for the detection of microorganisms in cell therapy products. However the standard 2-week cultivation period is too long for some cell-based treatments and alternative methods have to be devised. We tried to verify whether a shortened cultivation of the supernatant from the mesenchymal stem cell (MSC) culture obtained 2 days before the cell harvest could sufficiently detect microbial growth and allow the release of MSC for clinical application. We compared the standard Ph. Eur. cultivation method and the automated blood culture system BACTEC (Becton Dickinson). The time to detection (TTD) and the detection limit were analyzed for three bacterial and two fungal strains. The Staphylococcus aureus and Pseudomonas aeruginosa were recognized within 24 h with both methods (detection limit similar to 10 CFU). The time required for the detection of Bacillus subtilis was shorter with the automated method (TTD 10.3 vs. 60 h for 10-100 CFU). The BACTEC system reached significantly shorter times to the detection of Candida albicans and Aspergillus brasiliensis growth compared to the classical method (15.5 vs. 48 and 31.5 vs. 48 h, respectively; 10-100 CFU). The positivity was demonstrated within 48 h in all bottles, regardless of the size of the inoculum. This study validated the automated cultivation system as a method able to detect all tested microorganisms within a 48-h period with a detection limit of similar to 10 CFU. Only in case of B. subtilis, the lowest inoculum (similar to 10 CFU) was not recognized. The 2-day cultivation technique is then capable of confirming the microbiological safety of MSC and allows their timely release for clinical application.

Citovat

LYSAK, D., M. HOLUBOVA, T. BERGEROVA, M. VAVROVA, G. C. CANGEMI, R. CICCOCIOPPO, Peter KRUŽLIAK a P. JINDRA. Validation of shortened 2-day sterility testing of mesenchymal stem cell-based therapeutic preparation on an automated culture system. Cell and Tissue Banking. Dordrecht: Springer, 2016, roč. 17, č. 1, s. 1-9. ISSN 1389-9333. Dostupné z: https://dx.doi.org/10.1007/s10561-015-9522-9.

@article{1650038,
   author = {Lysak, D. and Holubova, M. and Bergerova, T. and Vavrova, M. and Cangemi, G. C. and Ciccocioppo, R. and Kružliak, Peter and Jindra, P.},
   article_location = {Dordrecht},
   article_number = {1},
   doi = {http://dx.doi.org/10.1007/s10561-015-9522-9},
   keywords = {Automated culture system; Cell therapy; Mesenchymal stem cells; Sterility; Validation},
   language = {eng},
   issn = {1389-9333},
   journal = {Cell and Tissue Banking},
   title = {Validation of shortened 2-day sterility testing of mesenchymal stem cell-based therapeutic preparation on an automated culture system},
   url = {https://link.springer.com/article/10.1007%2Fs10561-015-9522-9},
   volume = {17},
   year = {2016}
}

TY  - JOUR
ID  - 1650038
AU  - Lysak, D. - Holubova, M. - Bergerova, T. - Vavrova, M. - Cangemi, G. C. - Ciccocioppo, R. - Kružliak, Peter - Jindra, P.
PY  - 2016
TI  - Validation of shortened 2-day sterility testing of mesenchymal stem cell-based therapeutic preparation on an automated culture system
JF  - Cell and Tissue Banking
VL  - 17
IS  - 1
SP  - 1-9
EP  - 1-9
PB  - Springer
SN  - 13899333
KW  - Automated culture system
KW  - Cell therapy
KW  - Mesenchymal stem cells
KW  - Sterility
KW  - Validation
UR  - https://link.springer.com/article/10.1007%2Fs10561-015-9522-9
L2  - https://link.springer.com/article/10.1007%2Fs10561-015-9522-9
N2  - Cell therapy products represent a new trend of treatment in the field of immunotherapy and regenerative medicine. Their biological nature and multistep preparation procedure require the application of complex release criteria and quality control. Microbial contamination of cell therapy products is a potential source of morbidity in recipients. The automated blood culture systems are widely used for the detection of microorganisms in cell therapy products. However the standard 2-week cultivation period is too long for some cell-based treatments and alternative methods have to be devised. We tried to verify whether a shortened cultivation of the supernatant from the mesenchymal stem cell (MSC) culture obtained 2 days before the cell harvest could sufficiently detect microbial growth and allow the release of MSC for clinical application. We compared the standard Ph. Eur. cultivation method and the automated blood culture system BACTEC (Becton Dickinson). The time to detection (TTD) and the detection limit were analyzed for three bacterial and two fungal strains. The Staphylococcus aureus and Pseudomonas aeruginosa were recognized within 24 h with both methods (detection limit similar to 10 CFU). The time required for the detection of Bacillus subtilis was shorter with the automated method (TTD 10.3 vs. 60 h for 10-100 CFU). The BACTEC system reached significantly shorter times to the detection of Candida albicans and Aspergillus brasiliensis growth compared to the classical method (15.5 vs. 48 and 31.5 vs. 48 h, respectively; 10-100 CFU). The positivity was demonstrated within 48 h in all bottles, regardless of the size of the inoculum. This study validated the automated cultivation system as a method able to detect all tested microorganisms within a 48-h period with a detection limit of similar to 10 CFU. Only in case of B. subtilis, the lowest inoculum (similar to 10 CFU) was not recognized. The 2-day cultivation technique is then capable of confirming the microbiological safety of MSC and allows their timely release for clinical application.
ER  -

LYSAK, D., M. HOLUBOVA, T. BERGEROVA, M. VAVROVA, G. C. CANGEMI, R. CICCOCIOPPO, Peter KRUŽLIAK a P. JINDRA. Validation of shortened 2-day sterility testing of mesenchymal stem cell-based therapeutic preparation on an automated culture system. \textit{Cell and Tissue Banking}. Dordrecht: Springer, 2016, roč.~17, č.~1, s.~1-9. ISSN~1389-9333. Dostupné z: https://dx.doi.org/10.1007/s10561-015-9522-9.

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