BioReliance’s expanded Genetic Toxicology facilities in Rockville feature new laboratories, and additional scientific staff dedicated to these services. BioReliance was one of the first laboratories to offer contract toxicology testing services, beginning more than 60 years ago. It has provided genetic toxicology testing services for more than 40 years. In March 2008, BioReliance restructured its Toxicology and LADS services forming a new business unit, Toxicology and LADS, headed by Darryl L. Goss, Vice President.
Government regulations require Genetic Toxicology testing to identify the potential of drugs, chemicals and other products to damage DNA. With pharmaceuticals, Gene Tox tests are used throughout the drug development process including discovery, lead optimization, preclinical safety testing and to further investigate mechanism of action to help characterize human risk.
“Our focus is on providing predictive screening assays to support earlier lead optimization decisions, and mechanistic studies run later in the drug development process to allow compounds with gene tox positive results to achieve regulatory approval,” said David Bruning, Senior Director, Business Operations, Toxicology and LADS. “Another area of growth is the development and validation of Gene Tox assays to meet the anticipated ICH S2 revisions. These assays include in vivo Comet and flow cytometric analysis of peripheral blood micronucleus from repeat dose in vivo studies.”
ICH refers to the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, an organization that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry. ICH makes recommendations to achieve more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines while maintaining safeguards on quality, safety and efficacy, and regulatory obligations to protect public health.
“Expanding the facility is in response to the growing needs of the industry. Our dedicated staff works closely with regulatory agencies and customers to ensure faster and safer drug development. The additional capacity will allow us to serve our client’s screening and regulatory required testing needs faster and more efficiently with the highest degree of precision,” said Darryl Goss, Vice President, Toxicology and LADS unit.
About BioReliance
BioReliance Corporation is a leading specialist provider of cost-effective contract services to the pharmaceutical and biopharmaceutical industries, offering more than 1,000 tests or services related to biologics safety testing, in vitro and in vivo toxicology, viral manufacturing, GMP manufacturing, pre-clinical testing and lab animal health diagnostics. Founded in 1947 as Microbiological Associates, BioReliance is headquartered in Rockville, Maryland, and has primary facilities in Rockville, Glasgow, Scotland, Stirling, Scotland, and Edinburgh, Scotland, employing more than 700 people globally. For more information, visit www.bioreliance.com.
Contacts
Parallax Communications Group Scott Litherland, 317-638-7898 slitherland@parallaxgroup.net or BioReliance Corporation David Walker, Vice President & Chief Financial Officer 301-610-2866
