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Sekisui XenoTech Receives New US Patent for Kit and Method to Evaluate Xenobiotic Drug Metabolism in Hepatocytes

Sekisui XenoTech Receives New US Patent for Kit and Method to Evaluate Xenobiotic Drug Metabolism in Hepatocytes content piece image
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Sekisui XenoTech has been awarded US patent # 10,001,471 “In vitro test system to evaluate xenobiotics as immune-modulators of drug transport and metabolism in human hepatocytes.”

In 2014, Sekisui XenoTech patented an in vitro test system to evaluate how a xenobiotic (a substance not formerly found in the body; a small molecule or biologic drug) will interact with human hepatocytes. Xenobiotic metabolism is a core interest of Sekisui XenoTech, and the company last month received a product patent for a kit that allows testing to be conducted using a proprietary method.

Developed by Dr. Maciej Czerwinski, this in vitro process evaluates biologics for direct and cytokine-mediated effects on cytochrome P450 (CYP) enzyme expression. The cytokine release assay is the first step in the process, followed by examination of biologic-stimulated plasma in primary co-cultures of human hepatocytes and Kupffer cells. Consideration is given to the appropriate drug concentration that will yield the most relevant data on the release of cytokines and their downstream impact. Our patented and novel approach yields cytokine release information and detects the direct and cytokine-mediated effects of biologics on CYP and drug transporter expression.

Biologics are a fast growing area of therapeutics that encompass sugars, proteins, monoclonal antibodies, antibody conjugated drugs, nucleic acids and a range of innovative modifications applied to these structures. Interactions between biologics and small molecule drugs are important because cytokines (cell signaling molecules secreted by the immune system) are released upon exposure to some biologics and can suppress drug metabolizing enzymes. Cytokine-mediated suppression of drug metabolizing enzymes can change the clearance of small molecule drugs and thereby precipitate a drug-drug interaction.

FDA Guidance for Industry on drug interactions recognizes the potential for therapeutic proteins that are cytokines or cytokine modulators, to change the plasma concentration of specific enzyme and transporter mediated substrate drugs. Therapeutic proteins, which typically are not cleared by metabolism or transport involved in clearance of small molecule drugs, can suppress drug metabolizing enzymes and transporters by evoking response of the pro-inflammatory cytokines.

“As advancements are made in technology and regulations evolve to address these changes, we too are evolving with innovation and processes to match the needs of drug developers. Sekisui XenoTech is committed to driving innovation as a means of supporting both safety assessment and effective pipeline development for our clients. This body of work and patent that Dr. Maciej Czerwinski and other Sekisui XenoTech scientists have pioneered is an example of our commitment. We are extremely proud of the work we do and the impact we can have on public health,” stated COO, Dr. Darren Warren