HEPATOPAC: A Long-Term Hepatocyte Co Culture Model for ADME Tox Applications

Описание: Offered as a research service or kit, HEPATOPAC® is a long-term hepatic micropatterned co-culture (MPCC) that has been shown to provide superior data, especially for low turnover compounds, compared to conventional in vitro models. HEPATOPAC has been widely used in metabolism and toxicity studies and is now being adopted for other ADME applications.

The goal of providing more accurate preclinical data is the primary driving force behind the NAMs initiative that is a current focal point of regulatory agencies and industry organizations. HEPATOPAC falls under the NAMs category of Microphysiological Systems (MPS). As an established MPS, HEPATOPAC has been included in the new 3Rs Collaborative (3RsC) between regulators, technology providers, end-users, and non-profits to advance the use of MPS in regulatory applications.

With the NIH’s recent announcement that they will no longer issue Notices of Funding Opportunities exclusively supporting animal models combined with the potential benefits in the regulatory review process mentioned in the announcements for the FDA’s Roadmap to Reducing Animal Testing in Preclinical Safety Studies, the push to utilize validated NAMs is increasing in momentum.

The first webinar in this series, presented by Dipen Vyas, PhD, Study Director at BioIVT, evaluates the use of HEPATOPAC for a variety of ADME-Tox applications and outlines various study designs.

Conventional in vitro hepatocyte culture models can fail to predict the ADME-Tox properties of compounds with low metabolic turnover due to short-term viability and functionality. Micropatterned HEPATOPAC co-cultures are designed to provide long-term viability and functionality providing researchers a platform to evaluate the ADME-Tox properties of low turnover compounds for improved IVIVC.

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