Qualyst Transporter Solutions, LLC Announces Launch of New FDA Services Offering
June 18, 2012
The first integrated hepatocyte system to answer FDA‐related transporter questions
Research Triangle Park, N.C. -- Qualyst Transporter Solutions, LLC has launched a contract service offering using a clinically‐relevant model to assess FDA concerns on drug transporter related hepatic drug‐drug interactions. The newest FDA draft guidance
on drug interactions (February, 2012) specifies six hepatic drug transporters of interest, which include three uptake and three efflux transport proteins.
“What is missing in the market is a way to address FDA concerns around transporter‐based drug interactions that is predictive of an in vivo outcome.” said Dr. Christopher Black, CEO for Qualyst Transporter Solutions. “Utilizing the gold‐standard hepatocyte model, we have applied our clinically‐relevant B‐CLEAR® technology in order to produce a cost‐effective
answer to the FDA’s concerns,” said Dr. Black.
Many of the ways that current technologies try to address the FDA concerns involve in vitro transfected systems. Data from these systems are difficult to translate into reliable in vivo knowledge. An integrated in vitro system, like hepatocytes, with multiple localized, functioning, and expressed uptake and efflux transporters, is required to accurately predict and describe in vivo transporter‐based drug interactions.
Experiments can be performed in hepatocytes from multiple species, including humans, and the streamlined results are provided as a percent change from control. Clinically relevant positive controls are included in order to gauge the relative inhibitory potency of the tested compounds. Qualyst Transporter Solutions has a large historical data base which can help provide clinical perspective on the effects of your compound for an FDA submission. This can be important since many models overestimate inhibitory interactions or there may be inhibitory effects on a single transporter that can be compensated for by other transporters.
You need an integrated system to evaluate this. “Because we have hundreds of studies and years of experience with a variety of compound behavior, we can provide perspective to results that is difficult to get anywhere else and critical for the FDA,” said Dr. Kenneth Brouwer, CSO.
Qualyst Transporter Solutions only uses Transporter Certified™ hepatocytes and clinically relevant probe substrates along with positive control inhibitors to examine the potential for in vivo relevant transporter‐based drug interactions. The key to obtaining in vivo‐relevant answers is to use a fully integrated, functioning cell system that has been certified. “We certify our hepatocytes to ensure a fully functioning complement of uptake and efflux transporters, which guarantees that the results are in vivo‐relevant,” said Dr. Brouwer.
About Qualyst Transporter Solutions, LLC
Qualyst Transporter Solutions commercializes novel and proprietary drug transport and hepatobiliary disposition products for drug discovery and development. Qualyst Transporter Solutions products provide answers to transporter questions that arise in drug discovery and development. For additional information, please refer to the company's web site at www.qualyst.com or call (919) 313‐6500.
Qualyst Transporter Solutions, Christopher Black, Ph.D. Chief Executive Officer, (919) 313‐6511, firstname.lastname@example.org