SEKISUI XenoTech Receives New US Patent for Evaluating Xenobiotic Drug Metabolism in 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. The kit is not currently available for sale, however, customers have access to this technology through the company’s contract research services.
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
For more information regarding our newly patented and novel approach, please contact us.
About SEKISUI XenoTech
SEKISUI XenoTech, LLC is a global Contract Research Organization utilized by 98% of top pharma companies and numerous other organizations. For almost 25 years, the company has offered proven drug development expertise, providing an ever-evolving selection of cell and tissue-based products, screening, radiolabeling, API manufacturing, in vitro ADME Tox and pharmacology, in vivo ADME Tox and QWBA, metabolite ID and production, bioanalytical services and consulting. SEKISUI XenoTech’s product selection includes a wide range of high-quality unique and standard reagents, including subcellular fractions, hepatocytes, media, tissue samples, cell lines, recombinant enzymes, substrates & metabolites and more. The company also regularly prepares and delivers custom-designed products and services in response to client requests. For additional information, please refer to the company’s website at www.xenotech.com.