Until now, the supplying of cells and cell systems for research has been a highly fragmented and essentially a “commodity” business. Ascendance’s technology and know-how will, when funded, allow it to consolidate these markets into a single, high margin, high value added business that creates new profit sources for both Ascendance and its customers and/or partners.
Ascendance Biotechnology, Inc. (“Ascendance”) is a newly incorporated enterprise that has consolidated assets of Hepregen Corporation and the ESI BIO products division (“ESI”) of BioTime Inc., forming a leading transnational company selling cell-based assay products to the $20 billion cell biology marketplace. Hepregen has been the global leader in innovating unique, proprietary in vitro micro-liver cell-based platforms for use in safety testing, and pharmaceutical, biotherapeutic and diagnostic product development. Hepregen’s first application-oriented HepatoPac® and HepatoMune™ products have been driving a paradigm shift in drug development, forming the foundation of a sustainable core business with strong margins and high profit potential. The combination of Hepregen and ESI assets provides for a broadening of capabilities, allowing a world-class product development team to create new applications for its existing products and a suite of new products, including stem-cell-derived, HepatoStem™ products, and products comprised of additional key cell types. Moreover, applications to efficacy screening also provide Ascendance with opportunities to participate directly in the partnered development of therapeutic products.
Existing human, rat, monkey and dog HepatoPacTM products are based on proprietary micro-engineered co-cultures in which “islands” of liver cells remain alive for weeks at a time, and behave in a fashion essentially identical to liver cells in living organisms, enabling testing of new chemical entities in ways that were heretofore impossible. The utility of Ascendance products has already been established in collaboration with investigators at well-known pharmaceutical companies, such as Astra Zeneca, Boehringer Ingelheim, Merck, Novartis, Pfizer and Roche.
The ESI BIO human Embryonic Stem Cell Lines (hESC) were originally derived BioTime’s subsidiary ES Cell International Pte Ltd (ESI) under conditions that adhere to global ethical standards and conform to regulations controlling clinical-grade cell and tissue development (current Good Tissue Practices) and comply with current Good Manufacturing Practices (cGTPs and cGMPs). ESI BIO’s hES cell lines have their complete genome sequence available and are among the best-characterized and documented lines available today.
Membrane transporters can have important effects on pharmacokinetics and drug exposure as mentioned in the FDA's Guidance for Industry on Drug Interaction Studies*. HepatoPac®'s improved functionality and longevity have made it a valuable tool in assessing transporter-mediated uptake and efflux.
HepatoPac expresses most drug transporters and exhibits higher levels of transporter-mediated compound uptake compared to sandwich cultures. Furthermore, HepatoPac retains optimal transporter functions for several weeks compared to days in sandwich cultures. As a result of microengineering, the HepatoPac cellular architecture creates a highly reproducible in vitro model exhibiting a consistent and extensive bile canalicular network.
With the trend toward developing more stable compounds and extended dosing regimens, DMPK departments need to accurately predict turnover of even slowly metabolized compounds. The extremely limited lifespan of conventional suspension cultures precludes there use in determining clearance for these stable compounds.
HepatoPac® is an in vitro micropatterened co-culture of primary hepatocytes that retains functionality for up to four weeks. Its extended longevity and full complement of active phase I and phase II enzymes as well as transporters make it an ideal platform for predicting the metabolic stability of high, medium and low turnover compounds. When compared to industry-standard suspension cultures, HepatoPac's ability to perform long-term continuous incubations of stable compounds results in better metabolic stability predictions. Additionally, HepatoPac's proprietary architecture promotes intact bile caniliculi and active drug transporter activity, enabling studies of mechanistic clearance.
Extended Functionality Produces Increased Sensitivity
Given HepatoPac's longevity and stable enzymatic functions, the platform allows for the complete metabolism of pharmaceutical compounds. HepatoPac has been shown to be 20% more predictive in detecting primary and secondary excretory metabolites.
HepatoPac for Metabolic Stability Studies
Access the highly predictive power of HepatoPac™ using our Human HepatoPac™ Metabolic Stability Kit or through Hepregen Contract DMPK Services.
Accurate identification of drug metabolites is a key aspect of drug development. Moreover, the ability to correctly predict human in vivo metabolites can save both time and money in clinical development. Metabolites discovered in the clinic must be characterized and tested for safety. Because the exclusivity period for new drug sales is limited, not only does this exercise require additional product development effort and resources, but it also delays the product launch, resulting in major loss of revenue. More predictive platforms, such as HepatoPac®, help researchers make better selections among potential candidate molecules, thus avoiding surprises in the clinic.
Access the predictive power of HepatoPac using our HepatoPac MetID Kits or through Hepregen Contract DMPK Services.
In May of 2015, Hepregen announced a co-marketing agreement for a service to be offered with SCIEX, the gold-standard in LC/MS technology. This new Comprehensive Met ID Solution combines the increased metabolite production of HepatoPac's superior cellular machinery and NEW multi-species plate with SCIEX's TripleTOF®, SWATH™ Acquisition, and Metabolite Pilot™ software to generate, detect and analyze more metabolites than any other Met ID solution available today.
Ascendance Biotechnology proudly manufactures and provides the same Hepregen micro-liver HepatoPac® and HepatoMune™ cell-based assays and continues the world-class Solutions via Service™ contract services you have come to expect from Hepregen. The Hepregen products and services are based on our proprietary “Cell Micropatterning Technology” developed at the Massachusetts Institute of Technology that creates islands of living human liver cells in a “sea” of living stromal cells and are compatible with modern day, high-throughput drug screening techniques. The Hepregen line of human, rat, monkey, dog, and multi-species/multi-donor application-directed cell-based assays are driving a paradigm shift in drug development and have been validated in collaboration with investigators at several well-known pharmaceutical companies.
Approximately 50-60% of drugs that proceed through pre-clinical testing ultimately fail in humans, primarily because human metabolism and toxicity are difficult to predict in animals or in vitro. HepatoPac®, an in vitro micropatterened co-culture of primary hepatocytes and supportive stromal cells, is a proven, highly predictive tool for pre-clinical and clinical toxicity studies. Predictive tools such as HepatoPac, when deployed early in drug development, may help reduce the number of late stage failures thereby saving money and time.
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