Contact
QR code for the current URL

Press release Box-ID: 63179

JSW - Research Rankengasse 28 8020 Graz, Austria http://www.jswresearch.com
Contact Dr. Robert Wronski +43 316 258111212
Company logo of JSW - Research
JSW - Research

JSW - Research, Graz / Austria performs Gene Therapy Safety Monitoring for AMT B.V., Amsterdam / Netherlands

GLP certified BSL – II laboratory performs safety monitoring for AAV-1 based gene therapy

(PresseBox) (Graz, )
The Austrian contract research organization JSW acquired specific experience during the last couple of years in performing bio-distribution and safety studies for gene therapy programs. The company has developed and fully validated highly sensitive quantitative polymerase chain reaction procedures (qPCR) for detection of extremely small quantities of the gene of interest in different tissues and body fluids. For safety reasons it is important to guarantee extremely low detection thresholds either to quantify the distribution of the recombinant DNA through the whole organism or to ensure that organs and tissues different from the target tissue/organ do not carry any contamination of the gene of interest which has been transferred using the viral vector system.
For optimal treatment success with a high safety margin the expression of the gene of interest should take place in specified organs over specified time periods. The safety studies performed at JSW are defining not only the level of transgene copy number in different organ systems but also provide knowledge about transgene traceability in the course of time. The challenge is to guarantee lowest threshold levels of DNA detection to validate negative findings. In other words it must be guaranteed that finding no gene of interest really means that this tissue/organ is free of any contamination.
JSW’s staff invested enormous efforts into the development of these procedures in compliance with Good Laboratory Practice also considering the requested biological safety levels.
JSW developed a bio-distribution and safety screening for Amsterdam Molecular Therapeutics (AMT B.V., Amsterdam, The Netherlands) for their AAV-1 based gene therapy program. Investigations about bio-distribution of the therapeutic gene vector in mice were conducted at JSW. During the clinical test phase JSW routinely investigates now different human body fluids (serum, saliva, urine and sperm) to monitor the distribution and elimination of the viral vector in different organ systems.
Such careful and responsible investigations should help to define optimal safety for patients undergoing gene therapy in the future. For many patients, specifically those with congenital genetic defects, gene therapy offers great hope helping them to achieve optimal quality of life.
JSW is proud to be able to support these important therapeutic developments by safety monitoring on highest level of achievable quality.
The publisher indicated in each case is solely responsible for the press releases above, the event or job offer displayed, and the image and sound material used (see company info when clicking on image/message title or company info right column). As a rule, the publisher is also the author of the press releases and the attached image, sound and information material. The use of information published here is generally free of charge for personal information and editorial processing. Please clarify any copyright issues with the stated publisher before further use. In case of publication, please send a specimen copy to service@pressebox.de.
Important note:

Systematic data storage as well as the use of even parts of this database are only permitted with the written consent of unn | UNITED NEWS NETWORK GmbH.

unn | UNITED NEWS NETWORK GmbH 2002–2022, All rights reserved

The publisher indicated in each case is solely responsible for the press releases above, the event or job offer displayed, and the image and sound material used (see company info when clicking on image/message title or company info right column). As a rule, the publisher is also the author of the press releases and the attached image, sound and information material. The use of information published here is generally free of charge for personal information and editorial processing. Please clarify any copyright issues with the stated publisher before further use. In case of publication, please send a specimen copy to service@pressebox.de.