Universität zu Köln

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

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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
Creators:	Creators Email ORCID ORCID Put Code Stoermer, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Radojska, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hos, N. J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Gathof, B. S. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-403798
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
Uncontrolled Keywords:	Keywords Language HEMATOPOIETIC PROGENITOR; MICROBIAL-CONTAMINATION; SAFETY; CELLS Multiple languages Hematology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/40379