Gentronix announces full membership of the UK GLP monitoring programme and introduction of GLP in vitro genotoxicity services.
Posted on January 20, 2015 by stevebeasley
(Alderley Edge, Cheshire, UK. 20.01.2015) Gentronix Limited the specialist genetic toxicology provider announced today that it has become a full member of the UK GLP monitoring programme for the provision of genotoxicity testing.
The company has built a GLP team with extensive industrial experience in the performance of GLP studies and full membership of the programme is a landmark step for Gentronix as it continues to provide an extended range of genotoxicity services to its customers.
As part of the regulatory process for many sectors, new materials have to be tested to show that they are safe for use. An important part of this regulatory testing is to demonstrate that a chemical does not cause damage to DNA.
The regulatory testing, which must be performed to GLP standards is required to show that a chemical or a metabolite of the chemical does not cause mutations or structural changes that could potentially lead to cancer formation or inheritable disease.
No single regulatory assay can detect all types of DNA damage, therefore a battery of assays is used in order to fully characterise a compound. The first stage in this process is the in vitro assessment of genotoxicity.
The Ames reverse mutation assay (OECD 471) uses genetically modified bacteria that can only grow in growth limiting media conditions if a mutation occurs that allows the bacteria to again synthesize key nutrients.
In order to test for structural changes the in vitro micronucleus assay (OECD 487) has been widely adopted. This assay can be conducted in a number of different cell types with human lymphocytes and p53 competent TK6 lymphoblastoid cells being routinely used.
Gentronix now offers both Ames and in vitro micronucleus testing under GLP using the most up to date OECD protocols to generate studies ready for incorporation into regulatory dossiers.
John Nicholson, CEO of Gentronix commented “Gentronix is delighted to have achieved GLP compliance and to have further expanded its portfolio of genotoxicity assay offerings, so that with our accurate and speedy turnround standard, we can be recognised as the “go-to” genotoxicity company. ”
Gentronix Limited is a UK company specialising in genotoxicity for a range of industries including; pharmaceuticals, chemicals, agrochemicals, personal care, consumer products, flavours, fragrances and taste enhancers, and medical devices. Gentronix provides services and solutions helping a wide range of chemistry driven companies develop safer products more quickly at lower cost from early screening to GLP studies.
Gentronix is the inventor and owner of GreenScreen HC and BlueScreen HC human cell based assays for the pan-mechanistic detection of genotoxic hazard and offers these alongside an increasing range of non GLP and GLP assays for genetic toxicology.
GLP is a set of principles that provide a framework within which the consistency and quality of non-clinical health or environmental safety tests on the properties of chemical compounds, extracts and mixtures can be ensured. It is a legal requirement for regulatory submission in the fields of pharmaceuticals, agrochemicals, veterinary medicines, industrial chemicals, cosmetics, food and feed additives, and biocides, that such studies should be conducted in compliance with the principles of GLP.
For more information please contact;
Dr. Steve Beasley, Commercial Director
Tele: +44 (0)1625 238 742.