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SEKSIUI XenoTech expands access to Microsomal Protein Binding service for DMPK profile development and DDI assessment of new drugs

To help customers more easily investigate how much of their drug will be available to bestow its intended therapeutic effect, SEKISUI XenoTech is now offering Microsomal Protein Binding at both its Kansas City, KS headquarters as well as SEKISUI Medical’s lab at the Drug Development Solutions Center in Tokai, Japan. Although Plasma Protein Binding has been available at both laboratory locations, Microsomal Protein Binding was previously only available at SEKISUI’s labs in Japan.

Understanding the percentage of compound that is bound by proteins is critical to developing the drug metabolism and pharmacokinetics (DMPK) profile and assessing the drug-drug interaction (DDI) potential of a drug candidate because of the critical insight it provides into how the drug may be distributed throughout and cleared by the body.

Our definitive in vitro Microsomal and Plasma Protein Binding assays use Equilibrium Dialysis to determine free drug concentration (fraction unbound, fu).  Data from in vitro protein binding studies can be used for PK-related calculations, modeling, and design of IND-enabling studies outlined in guidance from FDA, EMA and PMDA. Learn more about in vitro protein binding studies, deliverables and regulatory expectations on our Microsomal and Plasma Protein Binding service page, or read more about our partnership with the Drug Development Solutions Center to complement our in vitro expertise with more than 50 years of in vivo ADME and radioisotope (RI) labeling experience.