The increased demand for BioReliance’s GeneTox services is partly due to the pharmaceutical industry’s desire to identify those drugs that are likely to fail pre-clinical and clinical trials earlier in the development cycle to help minimise the time and cost of bringing a drug to market.
The announcement also helps to add weight to the feeling that BioReliance has overcome the difficulties that saw Invitrogen offload the company to Avista Capital Partners in February 2007 for approximately $210m (€150m); less than half the price Invitrogen paid for it three years earlier.
Since then the company has restructured its toxicology and LADS (laboratory animal diagnostic services) divisions into a new business unit, opened offices in Japan to serve the expanding Asia-Pacific pharmaceutical industry, and introduced new assay technologies.
“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,” said Darryl Goss, vice president of BioReliance’s Toxicology and LADS business unit.
“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.”
Before a drug candidate can enter clinical trials, the US Food and Drug Administration (FDA) requires that developers identify any potential risk of the candidate causing damage to DNA.
Traditionally, these studies were carried out towards the end of preclinical testing by injecting the putative drug into live mice and then looking for damaged red blood cells formed in the bone marrow of the mice.
However, this approach led to many costly clinical trials delays and companies such as BioReliance are now offering in vitro genotoxicity studies that detect problems with potential drug candidates throughout the entire drug development process, from the early discovery and lead optimisation stages right through to preclinical safety testing.
“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 of Business Operations for BioReliance’s Toxicology and LADS unit.
Last September, BioReliance started offering Gentronix’ GreenScreen HC assay along with Ames II assays to provide highly predictive and sensitive detection of genotoxic compounds while minimizing the false positives seen with other in vitro assays.
The combination of these cell-based assays enables pharmaceutical firms to screen much smaller quantities of drug compounds than traditional in vivo studies enabling firms to test the genotoxicity profiles of their candidates much earlier during the development cycle.
In turn, this should help reduce the later stage attrition rates of drug candidates in development and enable pharmaceutical companies to reduce the costs of bringing a drug to market.