caa a22 4500 60615468X CHVBK 20210128100559.0 cr unu---uuuuu 210128e20150901xx s 000 0 eng 10.1007/s10561-014-9474-5 doi (NATIONALLICENCE)springer-10.1007/s10561-014-9474-5 A validation protocol and evaluation algorithms to determine compatibility of cell therapy product matrices in microbiological testing [Elektronische Daten] [Dieter Klarmann, Walid Sireis, Michael Hogardt, Volkhard Kempf, Erhard Seifried, Halvard Bonig] As part of product release testing, "sterility” of cellular therapy products, using formally validated methods, must be demonstrated, irrespective of whether products are released and administered while microbiological results are pending or whether these can be awaited. Components of the matrix, i.e. the carrier fluid and the therapeutic cells, could potentially inhibit bacterial growth and may thus obscure their presence, resulting in false-negative data. The European Pharmacopoeia and equivalent guidelines therefore specify that for each cell therapy product the specific matrix' compatibility with validated detection methods is formally established. There for, matrix is spiked with known numbers of representative aerobic and anaerobic agents, cultured in automated systems such as BacT/ALERT, followed by microbiological species identification from culture-positive bottles. We here propose an easy-to-follow protocol for matrix validation and demonstrate its successful execution with a panel of novel advanced therapy medicinal products and standard cell therapy products, as well as algorithms for interpretation of conflicting results between BacT/Alert and culture methods. This protocol can serve as a basis for microbiological method (matrix) validations for cellular preparations. Springer Science+Business Media Dordrecht, 2014 Advanced therapy medicinal product (ATMP) nationallicence Bacterial safety nationallicence Bioburden nationallicence Cellular products nationallicence Method validation nationallicence Microbiology nationallicence Pharmacopoeia nationallicence Klarmann Dieter German Red Cross Blood Service Baden-Württemberg-Hessen, Frankfurt, Germany aut Sireis Walid German Red Cross Blood Service Baden-Württemberg-Hessen, Frankfurt, Germany aut Hogardt Michael Institute for Medical Microbiology and Infection Control, Goethe University Medical Center, Frankfurt, Germany aut Kempf Volkhard Institute for Medical Microbiology and Infection Control, Goethe University Medical Center, Frankfurt, Germany aut Seifried Erhard German Red Cross Blood Service Baden-Württemberg-Hessen, Frankfurt, Germany aut Bonig Halvard German Red Cross Blood Service Baden-Württemberg-Hessen, Frankfurt, Germany aut Cell and Tissue Banking Springer Netherlands 16/3(2015-09-01), 311-318 1389-9333 16:3<311 2015 16 10561 https://doi.org/10.1007/s10561-014-9474-5 text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 brief-communication jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s10561-014-9474-5 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Klarmann Dieter German Red Cross Blood Service Baden-Württemberg-Hessen, Frankfurt, Germany aut NATIONALLICENCE 700 1- Sireis Walid German Red Cross Blood Service Baden-Württemberg-Hessen, Frankfurt, Germany aut NATIONALLICENCE 700 1- Hogardt Michael Institute for Medical Microbiology and Infection Control, Goethe University Medical Center, Frankfurt, Germany aut NATIONALLICENCE 700 1- Kempf Volkhard Institute for Medical Microbiology and Infection Control, Goethe University Medical Center, Frankfurt, Germany aut NATIONALLICENCE 700 1- Seifried Erhard German Red Cross Blood Service Baden-Württemberg-Hessen, Frankfurt, Germany aut NATIONALLICENCE 700 1- Bonig Halvard German Red Cross Blood Service Baden-Württemberg-Hessen, Frankfurt, Germany aut NATIONALLICENCE 773 0- Cell and Tissue Banking Springer Netherlands 16/3(2015-09-01), 311-318 1389-9333 16:3<311 2015 16 10561