|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