Specific aspects for virus safety of raw materials for cellular-based medicinal products

Virus safety of cell-based medicinal products is a particular challenge. These products are frequently manufactured using various human- or animal-derived starting and raw materials (serum and feeder-cells) in cell culture, which are possible sources for viral contamination. For living or proliferat...

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Bibliographic Details
Published in:Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Gesundheitsforschung, Gesundheitsschutz, 2015-11, Vol.58 (11-12), p.1233-1238
Main Authors: Stühler, Albert, Blümel, J
Format: Article
Language:ger
Subjects:
Biological Products - adverse effects
Biological Products - standards
Cell- and Tissue-Based Therapy - adverse effects
Cell- and Tissue-Based Therapy - standards
Drug Carriers - adverse effects
Drug Carriers - standards
Drug Contamination
Drug Industry
Pharmaceutic Aids - standards
Virus Cultivation - standards
Virus Inactivation
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Summary:Virus safety of cell-based medicinal products is a particular challenge. These products are frequently manufactured using various human- or animal-derived starting and raw materials (serum and feeder-cells) in cell culture, which are possible sources for viral contamination. For living or proliferating cells, no methods for virus inactivation (such as heat or chemical treatment) can be used and the options for testing these medicinal products for all possible viral contaminations are very limited. As a consequence, other safety measures, in particular careful selection and testing of starting and raw materials, are very important. For raw materials, attention should be paid to cell-culture additives of biological origin, such as human and bovine serum and porcine trypsin. Whenever possible, manufacturing steps for inactivation and removal of viruses should be introduced as an additional safety measure. In addition, recombinant products from animal cell cultures (such as growth factors, monoclonal antibodies for cell sorting, viral vectors) are used and have to be tested for virus safety.
ISSN:1437-1588
DOI:10.1007/s00103-015-2238-y