Leptospira contamination – How to manage risk
27th September 2012
By: Dr Daniel Galbraith, CSO,
Vaccines and Biologics are recognized to be at high risk of contamination by bacteria and viruses. Over many years the risks have been determined and these products are recognized to be among the safest on the market. In the past there have been a number of viral contamination events which have resulted in increased vigilance and additional testing for “in process” and final product tests. Recently, the announcement from Genentech that there was contamination by Leptospira sp. in two bioreactors has highlighted where potentially the testing paradigms may fail. Leptospira is an unusual organism in many respects but importantly can remain silent in all of the current tests used to identify contamination. In the Genentech incidents there were no live microbes present in the final product however there remains the possibility that this organism can contaminate batches of product and may be a risk to patients in the future.
There are a number of testing methods which can be used to identify Leptospira the method of choice will require to be sensitive and fast to report, clearly nucleic amplification techniques are ideal in this respect.
BioOutsource is pleased to announce the introduction of a sensitive PCR assay to detect Leptospira for our clients. The assay can be used to detect Leptospira contamination in cell banks as well as in process and final vialed product. From sample receipt to reporting results can be performed in 48 hours.