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Scientist on November 2, 2020

This installment of Supplier Spotlight® is on SEKISUI XenoTech – who proudly offer a uniquely qualified suite of nonclinical studies and test systems to help drug developers navigate through myriad possible circumstances and feel confident in partnership with true experts in ADME/DMPK/DDI.

What is your company’s mission?

Improve the health and welfare of society and future generations by supporting sustainable development of life-saving therapies through science grounded in excellence and quality.

What products and services do you offer?

We provide in vitro and in vivo nonclinical or clinical support studies, assay test systems and expert consultancy to evaluate drug metabolism and drug-drug interaction (DDI) potential of drug candidates in preclinical development. More specifically, SEKISUI XenoTech products and services are designed to elucidate ADME (absorption, distribution, metabolism and excretion) properties and interaction with drug transporters using cell and animal models, producing data that enables drug developers to identify DDI risk and predict likely metabolite formation following administration to humans. Services include medium-throughput screening for drug candidates in drug discovery; definitive, IND-enabling in vitro enzyme inhibition and induction assays; metabolite ID and characterization; reaction phenotyping; receptor binding; quantitative whole body autoradiography (QWBA) and mass balance animal studies; bioanalysis and others.

What problems does your organization solve?

Our products and services help researchers and drug developers meet regulatory expectations and address metabolism- and transporter-related questions about xenobiotics. The FDA and equivalent regulatory authorities have highlighted the importance of understanding whether a drug may cause harm by precipitating a drug-drug interaction as well as details about metabolites. We help our clients understand these aspects of their compounds. Additionally, our products are used by researchers in many fields. We are known for our human and animal hepatocyte options and extensive selection of cell fractions, but we also offer tissue samples, Kupffer cells, cell lines, recombinant enzymes, cytochrome P450 (CYP) substrates and metabolites, media and reagents and more. Our experienced team has developed a reputation for being able to handle more difficult compounds and prepare unique test systems that others simply cannot.

What are the most innovative tools and technologies that you offer?

We were among the very first CROs on the market to evaluate drug metabolism and associated risk, 25 years ago, and we have maintained our reputation for leadership ever since. SEKISUI XenoTech has consistently been on the leading edge, best known for top-tier data quality and guidance with both our contract studies and complementary test systems. Our dedicated service teams and products enable customers to achieve dependable data in drug metabolism and pharmacokinetics (DMPK) assays that meets or exceeds regulatory expectations. Our unique test system offerings include CryostaX® single-freeze cryopreserved human/animal hepatocytes (fewer steps from freezer to plate and less cryoinjury than competitors, conserving viability and maximizing performance) and our specialized Custom Products team, which can create tissue samples, cells or cell fractions specifically tailored to a wide variety of assay specifications.

What are your competitive advantages?

Our scientists have built a reputation over 25 years for unparalleled expertise in drug metabolism and drug-drug interaction nonclinical studies. In the words of Dr. Joanna Barbara, our VP of Scientific Operations, “We’ve seen the weird stuff.” When clients contract a SEKISUI XenoTech study, they know that we prioritize data quality first and a consultative approach next to ensure each and every study is carefully designed and executed to produce meaningful, reliable results. We are proud to have an outstanding return customer rate because we treat each study and product preparation with the attention our customers have come to expect – these molecules are precious, usually with many years and millions or billions of dollars in the making, so we are laser-focused on delivering superior quality to reflect that.

Who are your clients?

Despite our focused expertise in a specialized area, we serve a wide variety of customers. Primarily, we work with drug developers with small molecule drugs in preclinical development to fulfill a specific, important component of their IND data package. However, many people outside of this niche seek our products and services, including academics studying liver disease or cell biology, clients in Phase I or Phase II clinical trials who need to go back and resolve unexpected DDI results or to analyze patient plasma for metabolites, developers of agriculture chemical products exploring the intricacies of target insect metabolism, etc. Our customers include everyone from virtual pharmaceutical and small biotechnology companies all the way to 98% of top pharma.

What new products and services are you developing in 2020?

We are continuously adding new cellular products to our portfolio to address client and market needs. New services include In Silico models for DDI assessment, in vitro toxicity testing (including Hepatoxicity).

Where are your laboratories and offices located?

Our global headquarters is centrally located in Kansas City, KS (USA). All in vivo animal studies are conducted at our partner facility, the illustrious Drug Development Solutions Center in Tokai, Japan. We regularly perform contract studies for clients all over the world, with service representatives in North America and Europe. To accommodate international product customers, we have distributors to reach most countries outside the US. Contact us to find a distributor near you.

Connect with SEKISUI XenoTech