Studies in Japan: Easier & More Beneficial than You Might Think

XenoTech is well-known to pharmaceutical companies and toxicology academics alike for unparalleled experience in quality in vitro ADME/DMPK/DDI studies and complementary products, but our expert services span beyond preclinical. Through our partner Tokai laboratory in Japan, the Tokai Drug Development Solution Center, we cater to needs from screening all the way through phase 2 clinical stage. Our partner campus is the number one market share holder in ADME studies in Japan and offers the widest range of transporter studies in the world. The 150,000-square foot laboratory hosts experts who specialize in both in vivo and in vitro comprehensive services and has assisted drug developers to vet successful compounds for more than 45 years.

The FDA has been clear in emphasizing early determination of safety and efficacy of compounds, not only to expedite compounds from discovery to market but also to maximize efficiency in time and resource management. The Tokai facility is unique and well-known in its field for its outstanding quality in radiochemical work. Myriad autoradiography services present opportunity to adequately describe pharmacokinetic pathways and identify relevant metabolites of an investigational drug. Expert radiochemists plan every step to synthesize custom radiochemical compounds for various ADME studies, including mass balance and QWBA (quantitative whole body autoradiography). From outset, clients work with their study director to tailor their study design according to individual needs in route and yield at each step, labeling position, isomers, radiochemical purity, target delivery rate, and more.

For United States companies, the idea of sending compounds to labs outside the country may be daunting, but partnering with XenoTech makes it easy and customers can have every confidence that studies at both campuses are carried out with the highest quality and regard for your needs and values.

All studies in a package with XenoTech are seamlessly managed by a designated study director who will coordinate all communications throughout the process. Our team of experts have built a strong reputation for quick response time, regardless of the campus on which testing occurs.

Turnaround time and cost are much more efficient than one might think for utilizing a lab in Japan. The level of expertise held by the Tokai Drug Development Solution Center team translates to more efficiency in processes to radiolabel compounds, and because pricing of radiochemical services is informed in large part by steps in these processes, our customers can save money and time by working with both labs.

Shipping and handling radioactive materials between countries can be tricky, especially considering the purity that must be validated and maintained to assure quality results, but our experienced team also has a thorough understanding of Japanese customs regulations, and will facilitate fast, safe and careful transport of materials to ensure clients’ compounds are protected.

Working with a lab in Japan has additional benefits, as well. Recent tariffs will begin to negatively impact the pharmaceutical industry’s ability to trade easily with China[1], so some companies are looking for alternatives which will be cost-effective and safe. Furthermore, when outsourcing highly-sensitive materials, concern for IP protection is paramount, and by partnering with us you can have confidence that safety and confidentiality are stringently guarded.

Studies conducted at the Tokai Drug Development Solution Center also meet or exceed standards required by the FDA, just as our Kansas City campus. While in the United States, there is no method by which an institution can claim certified compliance with GLP standards, but in Japan the PMDA can grant certification following inspection which approves a facility as GLP-compliant in specific practices. Tokai has this certification and also is AAALAC certified for animal welfare for in vivo studies, so you can be sure services exceed quality standards required by the FDA upon IND submission.

When planning for ADME and toxicity studies, XenoTech covers a lot of bases. In partnering with us for in vivo components as well as in vitro assays to evaluate safety of a compound, you can count on quality testing methods, high standards of customer support, and unmatched expertise.

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^{[1] GlobalData Healthcare. “Is the Biopharma Industry Safe from the US-China Trade War?” Pharmaceutical Technology, 12 Apr. 2018, www.pharmaceutical-technology.com/comment/biopharma-industry-safe-us-china-trade-war/.}