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| home > ebr > spring 2003 > variant creutzfeldt-jakob disease: safety of blood and plasma products |
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European BioPharmaceutical Review
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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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Inaugural Conference on Pre-Filled Syringes
21-22 January 2009, Crowne Plaza Hotel - St James, London, UK
SMi present their Inaugural Conference on Pre-Filled Syringes 21st and 22nd January 2009 at the Crowne Plaza Hotel - St James, London, UK
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Azopharma Product Development Group, Inc
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today the addition of innovative state-of-the-art equipment at its formulation and manufacturing division, ApiCross Drug Delivery Technologies in Hollywood, Florida. The most recent acquisition is the MG Futura Capsule Filler which delivers the latest in capsule filling technology. The company has also added a Bausch & Strobel Aseptic Filling Isolator, equipment that is ground-breaking in the powder filling process. These additions support our previously implemented XcelodoseTM powder micro-dosing system. With these technologies, Azopharma is able to provide its clients with all forms of the capsule filling process. The new equipment is part of Azopharma’s recent manufacturing expansion which includes 17 new manufacturing suites for GMP, cytotoxic and aseptic products...
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