Stoermer, M., Radojska, S., Hos, N. J. and Gathof, B. S. (2015). Protocol for the validation of microbiological control of cellular products according to German regulators recommendations - Boon and Bane for the manufacturer. Vox Sang., 108 (3). S. 314 - 318. HOBOKEN: WILEY. ISSN 1423-0410
Full text not available from this repository.Abstract
In order to generate standardized conditions for the microbiological control of HPCs, the PEI recommended defined steps for validation that will lead to extensive validation as shown in this study, where a possible validation principle for the microbiological control of allogeneic SCPs is presented. Although it could be demonstrated that automated culture improves microbial safety of cellular products, the requirement for extensive validation studies needs to be considered.
Item Type: | Journal Article | ||||||||||||||||||||
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URN: | urn:nbn:de:hbz:38-408686 | ||||||||||||||||||||
DOI: | 10.1111/vox.12222 | ||||||||||||||||||||
Journal or Publication Title: | Vox Sang. | ||||||||||||||||||||
Volume: | 108 | ||||||||||||||||||||
Number: | 3 | ||||||||||||||||||||
Page Range: | S. 314 - 318 | ||||||||||||||||||||
Date: | 2015 | ||||||||||||||||||||
Publisher: | WILEY | ||||||||||||||||||||
Place of Publication: | HOBOKEN | ||||||||||||||||||||
ISSN: | 1423-0410 | ||||||||||||||||||||
Language: | English | ||||||||||||||||||||
Faculty: | Unspecified | ||||||||||||||||||||
Divisions: | Unspecified | ||||||||||||||||||||
Subjects: | no entry | ||||||||||||||||||||
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URI: | http://kups.ub.uni-koeln.de/id/eprint/40868 |
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