|By PR Newswire||
|March 19, 2014 07:19 AM EDT||
ALDERLEY EDGE, England, March 19, 2014 /PRNewswire/ --
Gentronix Limited, the leading specialist genotoxicity company, has announced its strategic intention to offer regulatory genotox assays, and is currently working towards 'Good Laboratory Practice' (GLP) compliance.
GLP is a quality system of management controls for research laboratories to ensure the quality and reliability of test data from non-clinical safety studies. Specifically, these are studies to examine the properties and/or safety of chemical compounds, extracts and mixtures, where data are intended for submission to regulatory authorities[i],[ii] in the fields of pharmaceuticals, agrochemicals, veterinary medicines, industrial chemicals, cosmetics, food and feed additives and biocides[iii].
Test facilities that conduct regulatory studies must, by law, join the compliance monitoring programme. This process begins, once all of the appropriate systems, facilities, and qualified personnel are in place, with an application to the GLP Monitoring Authority. (GLPMA). This application is reviewed by the GLPMA and the company's systems, facilities and personnel are audited. If successful, the company is awarded a 'Statement of GLP Compliance', and is permitted to offer GLP services. This certification is subject to continuing compliance which is verified by periodic re-auditing.
As specialists in genotoxicity, Gentronix intends to initially offer GLP compliant Ames and in vitro micronucleus (MNT) tests as prescribed in the "OECD Guidelines for the Testing of Chemicals, Section 4: Health Effects" tests 471: Bacterial Reverse Mutation and 487: In Vitro Mammalian Cell Micronucleus Test.
Gentronix Chairman and CEO John Nicholson said "While this is a major investment for Gentronix, it is also an important strategic move which will allow us to offer a wider spectrum of genotoxicity testing from early screening through mechanism studies to final regulatory submission, thereby positioning ourselves as the "go-to" genotox company. Experienced Study Directors have already been recruited and we are continuing to recruit staff with GLP experience."
Gentronix provides services and solutions to help organisations optimise the development of drugs and other chemicals, by reducing attrition due to toxicity thus ensuring safer products across a wide range of chemistry driven industries.
In addition to our patented human cell GADD45a reporter assays for early screening (GreenScreen® HC and BlueScreen™ HC), we now offer an expanded portfolio of screening assays, such as Ames MPF™ and Microflow™ MNT, as well as a range of mechanistic follow-up assays including in vivo MNT, H2AX by flow cytometry, Apoptosis induction by Annexin-V binding and caspase 3/7 activity, and the Comet assay.
Gentronix has recruited an expanded team of highly experienced people, and are now also able to offer full non-GLP Ames and slide scored human lymphocyte MNT.
For further information, please contact: Steve Beasley, Commercial Director, Gentronix Limited, BioHub at Alderley Park, Alderley Edge, Cheshire. SK10 4TG, UK. T +44(0)1625-238742 E [email protected]
i. The Good Laboratory Practice Regulations 1999 [http://www.legislation.gov.uk/uksi/1999/3106/contents/made ]
ii. The Good Laboratory Practice (Codification Amendments Etc.) Regulations 2004 [http://www.legislation.gov.uk/uksi/2004/994/introduction/made ]
iii. "Good Laboratory Practice: Background and structure [http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodLaboratoryPractice/Structure ]", MHRA website
SOURCE Gentronix Limited
Oct. 1, 2016 04:30 PM EDT Reads: 1,317
Oct. 1, 2016 04:00 PM EDT Reads: 3,729
Oct. 1, 2016 04:00 PM EDT Reads: 1,303
Oct. 1, 2016 03:45 PM EDT Reads: 607
Oct. 1, 2016 03:30 PM EDT Reads: 1,198
Oct. 1, 2016 03:30 PM EDT Reads: 1,765
Oct. 1, 2016 03:15 PM EDT Reads: 2,527
Oct. 1, 2016 03:00 PM EDT Reads: 3,068
Oct. 1, 2016 01:30 PM EDT Reads: 871
Oct. 1, 2016 01:00 PM EDT Reads: 5,191
Oct. 1, 2016 12:30 PM EDT Reads: 3,276
Adobe is changing the world though digital experiences. Adobe helps customers develop and deliver high-impact experiences that differentiate brands, build loyalty, and drive revenue across every screen, including smartphones, computers, tablets and TVs. Adobe content solutions are used daily by millions of companies worldwide-from publishers and broadcasters, to enterprises, marketing agencies and household-name brands. Building on its established design leadership, Adobe enables customers not o...
Oct. 1, 2016 12:30 PM EDT Reads: 657
SYS-CON Events announced today the Enterprise IoT Bootcamp, being held November 1-2, 2016, in conjunction with 19th Cloud Expo | @ThingsExpo at the Santa Clara Convention Center in Santa Clara, CA. Combined with real-world scenarios and use cases, the Enterprise IoT Bootcamp is not just based on presentations but with hands-on demos and detailed walkthroughs. We will introduce you to a variety of real world use cases prototyped using Arduino, Raspberry Pi, BeagleBone, Spark, and Intel Edison. Y...
Oct. 1, 2016 12:30 PM EDT Reads: 3,128
Just over a week ago I received a long and loud sustained applause for a presentation I delivered at this year’s Cloud Expo in Santa Clara. I was extremely pleased with the turnout and had some very good conversations with many of the attendees. Over the next few days I had many more meaningful conversations and was not only happy with the results but also learned a few new things. Here is everything I learned in those three days distilled into three short points.
Oct. 1, 2016 12:30 PM EDT Reads: 5,551