2008
DOI: 10.1515/cclm.2008.175
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Microbial safety of cell based medicinal products – what can we learn from cellular blood components?

Abstract: Today, sterility of established parenteral drugs including biologicals, such as plasma derived products, is practically guaranteed. Bacterially contaminated products are extremely rare exceptions owing to the efficiency of the manufacturing processes in the pharmaceutical industry. In contrast, the manufacturing processes of cell based medicinal products or tissue preparations show much less defined conditions. The sterility of source materials cannot be guaranteed in many cases. As a rule, these source materi… Show more

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Cited by 14 publications
(15 citation statements)
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“…Levels of endotoxin, mycoplasma, superfluous ancillary components and CD3 negative impurities carried over from the apheresis must be within tightly defined conformance limits . Microbial safety is a significant concern for CAR‐T products and cellular therapeutics in general, as the manufacturing processes have much less defined conditions than conventional parenteral drugs . Ensuring the sterility of source materials can be problematic and final product sterilisation is not applicable.…”
Section: In‐process Control and Release Testingmentioning
confidence: 99%
See 1 more Smart Citation
“…Levels of endotoxin, mycoplasma, superfluous ancillary components and CD3 negative impurities carried over from the apheresis must be within tightly defined conformance limits . Microbial safety is a significant concern for CAR‐T products and cellular therapeutics in general, as the manufacturing processes have much less defined conditions than conventional parenteral drugs . Ensuring the sterility of source materials can be problematic and final product sterilisation is not applicable.…”
Section: In‐process Control and Release Testingmentioning
confidence: 99%
“…43,96 Microbial safety is a significant concern for CAR-T products and cellular therapeutics in general, as the manufacturing processes have much less defined conditions than conventional parenteral drugs. 102 Ensuring the sterility of source materials can be problematic and final product sterilisation is not applicable. Conventional methods of sterility testing may be less sensitive for cell-based products; for example, sterility of a sample may not ensure sterility of the whole infusion product and standard sterility test protocols, such as microbiological growth media inoculation may not detect all potential contaminants.…”
Section: In-process Control and Release Testingmentioning
confidence: 99%
“…The turbidity of the medium is used as parameter for microbial growth. Sample preparation can be performed by direct inoculation or filtration . Moreover, automated culture systems (e.g.…”
Section: Concepts Of Microbial Safetymentioning
confidence: 99%
“…To harmonize future studies, Montag et al . [40] developed and characterized bacterial standards within the ISBT working party for transfusion‐transmitted infectious diseases. All bacterial standards are ready to use frozen samples containing a defined number of viable bacterial colonies.…”
Section: Experimental Bacterial Detection Systemsmentioning
confidence: 99%