BioReliance, Sigma-Aldrich Corporation's biologics and early-development services business under SAFC Commercial, has introduced select 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. "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."

Designed in accordance with guidelines from agencies like the FDA, EMA and ITC, the assays help customers 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 customers in discovery phases can more easily isolate any compounds that may affect product development before it 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, Ph.D, Head of Discovery Research Services at Sigma-Aldrich. "Our expanding portfolio of cell lines, available as products and now services is creating the most comprehensive and accessible platform for in vitro ADME and toxicology testing in the market."