BioReliance introduces advanced in vitro ADME and toxicology services
Designed to improve drug safety and efficacy
BioReliance, Sigma-Aldrich Corporation's biologics and early-development services business, has introduced in vitro ADME (absorption, distribution, metabolism and excretion) and toxicology testing services for pharmaceutical, chemical and industrial consumer products to its service offering.
The broad set of highly predictive assays use a novel suite of genetically modified cell lines created with CompoZr zinc finger nuclease (ZFN), a Sigma-Aldrich proprietary technology.
'The new in vitro ADME and toxicology testing services complement the existing genetic toxicology testing portfolio at BioReliance, and have been designed to meet the growing demand for more predictive human cell-based assays,' said Daniel Aparicio, Executive Director and General Manager of Toxicology at BioReliance, which is part of the SAFC Commercial division. 'The services are a valuable evolution from our synergies with Sigma-Aldrich products, and have been designed to decrease risk and total cost of ownership for customers in the discovery phase.'
Following guidelines from agencies such as the FDA, EMA and ITC, the assays help customers to predict outcomes by determining levels of permeability, transport, metabolism and toxicity in a drug product. Each cell line is tested for functionality, which means that any compounds that may affect product development can be isolated before they can affect the safety or efficacy of a possible drug product.
'A shift in emphasis to testing in earlier phases of drug discovery and development, increasing efforts to reduce cost, stricter regulatory guidance, and a reduction in animal usage is driving the demand for more predictive in vitro ADME and Tox assays and services,' said Paul Brooks, Head of Discovery Research Services at Sigma-Aldrich.
