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European Biopharmaceutical Review

Variant Creutzfeldt-Jakob Disease: Safety of Blood and Plasma Products

Transmissible spongiform encephalopathies (TSEs) are rare but invariably fatal neurodegenerative disorders affecting both animals and humans. The infectious agent is a modified form of a naturally occurring protein, composed largely of a self-replicating protein referred to as a prion.

In 1996 a new variant of Creutzfeldt-Jakob disease (vCJD) was described in Great Britain. Cases of vCJD are very rare and have occurred primarily in Great Britain. According to the British Department of Health, as of 6th January 2003 the number of probable or confirmed cases of vCJD in the UK had risen to 129. In addition, there have been six cases in France, one in the Republic of Ireland and one in Italy as well as one in the US. (This last case had been a resident in the UK but it is regarded as a US case. This is because cases are normally assigned to the country of residence at the time of onset of symptoms.)


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By Sonja Lenz, Study Director, Klaus Kellings, Business Development Regional Manager, and Helga Siakkou, Quality Control Manager, at NewLab BioQuality AG

Sonja Lenz has been Study Director for prion studies at NewLab BioQuality AG since 2001. She studied Chemical Engineering at the Niederrhein University of Applied Sciences in Krefeld, and at NewLab she was responsible for establishing and validating the Western blots used in these studies.

Sonja has also performed several GLP-compliant studies whose results have been presented at various international meetings.

Dr Klaus Kellings works in the Business Development department at NewLab BioQuality AG. Prior to this position, he acted as Study Director for Virology at NewLab, responsible for viral and prion process validation studies. He gained experience in prion research during his studies in Biophysics at the University of Dьsseldorf and his post-doctoral research at the University of California in San Francisco. This experience has been invaluable in establishing the prion techniques used at NewLab.

Dr Helga Siakkou is currently Quality Control Manager at NewLab. She obtained her degree in Biochemistry at the State University of Kharkov, Ukraine, and a PhD in Molecular Biology and Virology from the Academy of Sciences in Berlin, Germany. Her research interests lie primarily in the area of retrovirus research. Helga has worked at NewLab BioQuality AG since 1994.
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Sonja Lenz
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Dr Klaus Kellings
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Dr Helga Siakkou
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