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Bacterial safety of cell‐based therapeutic preparations, focusing on haematopoietic progenitor cells
Author(s) -
Störmer M.,
Wood E. M.,
Schurig U.,
Karo O.,
Spreitzer I.,
McDonald C. P.,
Montag T.
Publication year - 2014
Publication title -
vox sanguinis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.68
H-Index - 83
eISSN - 1423-0410
pISSN - 0042-9007
DOI - 10.1111/vox.12097
Subject(s) - haematopoiesis , microbiology and biotechnology , risk analysis (engineering) , computer science , biochemical engineering , sterility , stem cell , medicine , biology , engineering , genetics
Bacterial safety of cellular preparations, especially haematopoietic progenitor cells ( HPC s), as well as advanced therapy medicinal products ( ATMP s) derived from stem cells of various origins, present a challenge for physicians, manufacturers and regulators. The article describes the background and practical issues in this area and illustrates why sterility of these products cannot currently be guaranteed. Advantages and limitations of approaches both for classical sterility testing and for microbiological control using automated culture systems are discussed. The review considers novel approaches for growth‐based rapid microbiological control with high sensitivity and faster availability of results, as well as new methods for rapid bacterial detection in cellular preparations enabling meaningful information about product contamination within one to two hours. Generally, however, these direct rapid methods are less sensitive and have greater sampling error compared with the growth‐based methods. Opportunities for pyrogen testing of cell therapeutics are also discussed. There is an urgent need for development of novel principles and methods applicable to bacterial safety of cellular therapeutics. We also need a major shift in approach from the traditional view of sterility evaluation (identify anything and everything) to a new thinking about how to find what is clinically relevant within the time frame available for the special clinical circumstances in which these products are used. The review concludes with recommendations for optimization of microbiological control of cellular preparations, focusing on HPC s.