AFFINERGY, LLC — Department of Health and Human Services SBIR Phase I: DESCRIPTION (provided by applicant): In order to reduce the cost of bringing a new drug t

AFFINERGY, LLC — SBIR Phase I award from Department of Health and Human Services.

Amount
$280,547
Agency
Department of Health and Human Services · National Institutes of Health
Program / Phase
SBIR · Phase I
Solicitation
PA13-234
NAICS
Place of performance
NC
Period

Description

DESCRIPTION (provided by applicant): In order to reduce the cost of bringing a new drug to market, drug candidates with a high probability for failure must be identified early in their development. The pharmaceutical industry employs in vitro liver modelsto screen new drugs for undesirable toxic metabolites and harmful drug-drug interactions. Primary human hepatocytes are the preferred model for assessing drug metabolism, hepatoxicity, drug-drug interactions, and CYP450 enzyme induction. However, the availability of fresh human hepatocytes is unpredictable, leading researchers to develop cryopreservation methods that enable long-term hepatocyte storage. Despite the advantages of this technique, 50% of hepatocytes lose their ability to attach to culture plates following cryopreservation. Unlike plated hepatocytes that remain viable for days to weeks, hepatocytes in suspension are only viable for a few hours; thus, non-plateable hepatocytes are limited in use to only short-term metabolic assays. Ultimate