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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter / Tate, Jillian R.


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Microbial safety of cell based medicinal products – what can we learn from cellular blood components?

Thomas Montag1 / Sven-Boris Nicol2 / Utta Schurig3 / Margarete Heiden4 / Helga Huber5 / Ralf Sanzenbacher6 / Egbert Flory7 / Michael Schwanig8 / Christian K. Schneider9

1Paul Ehrlich Institute, Federal Agency for Sera and Vaccines, Langen, Germany

2Paul Ehrlich Institute, Federal Agency for Sera and Vaccines, Langen, Germany

3Paul Ehrlich Institute, Federal Agency for Sera and Vaccines, Langen, Germany

4Paul Ehrlich Institute, Federal Agency for Sera and Vaccines, Langen, Germany

5Paul Ehrlich Institute, Federal Agency for Sera and Vaccines, Langen, Germany

6Paul Ehrlich Institute, Federal Agency for Sera and Vaccines, Langen, Germany

7Paul Ehrlich Institute, Federal Agency for Sera and Vaccines, Langen, Germany

8Paul Ehrlich Institute, Federal Agency for Sera and Vaccines, Langen, Germany

9Paul Ehrlich Institute, Federal Agency for Sera and Vaccines, Langen, Germany

Corresponding author: Thomas Montag-Lessing, MD, Paul-Ehrlich-Institute, Paul-Ehrlich-Straße 51–59, 63225 Langen, Germany

Citation Information: Clinical Chemistry and Laboratory Medicine. Volume 46, Issue 7, Pages 963–965, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: 10.1515/CCLM.2008.175, July 2008

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 materials cannot be sterilised, as it holds true for the final products. Furthermore, the established methods for sterility testing are not applicable for cell preparations. Sterility of a restricted sample does not guarantee sterility of the whole preparation. Thus, small amounts of residual bacteria in the product can be overlooked and can grow up to enormous numbers during storage and shipping of cell based medicinal products. Considering these problems, there are some parallels in the warranty of microbial safety of cellular blood components. Therefore, the experiences collected in transfusion medicine in the past decade can be successfully used in the production of cell based medicinal products. Comparable to the situation regarding cellular blood components, there is a need for new principles in rapid bacteria detection.

Clin Chem Lab Med 2008;46:963–5.

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