Speeding up ADME

BD Biosciences, BioTrove to provide a solution from sample prep to data analysis

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WOBURN, Mass.—BioTrove Inc. last month announced an exclusive alliance with its Woburn, Mass., neighbor BD Biosciences to provide customers with a complete solution for sample preparation and data analysis of high-throughput in vitro ADME assays. BD Biosciences will work directly with customers that order the service, then generate the assays and plates which BioTrove will process. BD Biosciences will then communicate the results to the customer. Targeted turn-around time is seven business days. Financial terms of the agreement were not released. 

BD Biosciences is a major provider of products and services for a wide range of in vitro ADME assays. The company's BD Gentest fluorescent assays and recombinant enzymes expressing specific P450 enzymes support the pharmaceutical and biotech industry with products and services for high-throughput CYP450 inhibition assays. Organized as a new screening service with proprietary RapidFire Technlogy that combines BD's expertise in the field of ADME, with BioTrove's high-throughput mass spectrometry technology, the two companies claim it's a "first-of-its-kind offering."

"The unique, research-enabling aspect of our new BioTrove-BD Biosciences service is not the assay, but the type of analysis used: mass spectrometry," says Can "Jon" Özbal, vice president and general manager of BioTrove's RapidFire Business Unit. Typically, he notes, the number of test compounds that must be analyzed in the discovery stage is far larger than the number that need analysis in drug development. In development, since there are fewer compounds to evaluate, most pharmaceutical and biotechnology companies prefer to perform CYP450 inhibition assays using drug probes specified in the draft FDA guidance (dated September 2006), which are compatible with mass spectrometry as the analytical readout.

In the discovery stage, on the other hand, the large number of samples typically creates an analytical bottleneck for mass spectrometric methods. As a result, most organizations choose to perform discovery-stage CYP450 inhibition assays with alternate methods, such as fluorescence-based assays. Since these are non-drug probes and are not among the "preferred" and "acceptable" probes in the draft FDA guidance concerning drug interactions, compounds that move on to the development stage are usually reevaluated using these probes at a later point.

BioTrove has offered customers CYP450 inhibition assays on the RapidFire platform directly for more than two years. With 11 of the top 15 pharmaceutical and biotechnology companies worldwide using RapidFire technology—either through BioTrove's own CRO or through the purchase of RapidFire systems—these protocols have been thoroughly validated, the company claims.

BioTrove and BD Biosciences are already working on expanding CYP450 inhibition assays to include time-dependent inhibition (TDI) assays as well as P-glycoprotein (P-gp) inhibition assays.  Longer term goals include a complete in vitro ADME suite of assays and will likely include metabolic stability assays, PAMPA assays, transporter assays beyond P-gp assays, and plasma protein binding assays, Özbal notes. DDN

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