Sekisui Medical Co.,Ltd.

Sekisui Medical Co.,Ltd. (hereinafter referred to as “Sekisui Medical”) is a contract research organization (CRO) specializing in nonclinical pharmacokinetic studies using radiolabeled compounds. This overview presents the characteristics of Sekisui Medical’s nonclinical studies, representative disease models, and case examples. Please use it as a reference when selecting a CRO for nonclinical studies.

Non-Clinical Studies at Sekisui Medical

Pharmacokinetic studies using radiolabeled compounds

They have strong capabilities in absorption, distribution, metabolism, and excretion (ADME) studies utilizing radiolabeled compounds (e.g., 14C, 3H). Their technology supports prediction of pharmacokinetics from microdose and microtracer studies to project clinical-dose profiles with high accuracy. For intravenous administration, the prediction error for clearance and volume of distribution is within a factor of 2. For oral administration, appropriate evaluation informed by the Biopharmaceutics Drug Disposition Classification System (BDDCS) is feasible. They support drug development from early stages through proof of concept (POC) by designing studies in accordance with international standards (FDA, ICH) and by leveraging advanced facilities, including Accelerator Mass Spectrometry (AMS).

Diverse species and disease models

They conduct studies in a wide range of species, including rats, mice, dogs, nonhuman primates (NHPs), and miniature pigs, and maintain a broad portfolio of disease models across therapeutic areas such as oncology, metabolic disease, and neurological disease. They select appropriate models to support drug discovery research and conduct safety and pharmacology studies in compliance with GLP regulations to improve the efficiency of the discovery cycle.

Quality control in accordance with international standards

In addition to a GLP testing framework, it maintains ISO 9001 (certified 2004) and ISO 13485 (upgraded 2016) and enforces quality assurance aligned with investigational drug GMP and GCP requirements. They have established data-integrity (DI)–compliant LC-MS/MS measurements and a stable supply system for radiolabeled compounds. The Drug Discovery Support Center has received PMDA conformity assessment and provides robust support for preparing application data for regulatory authorities in Japan and overseas.

Partner CROs (collaborations with Sekisui Medical)

Bozo Research Center Inc.

Founded in 1972, Bozo Research Center conducts a broad range of contracted nonclinical studies from discovery through the clinical development interface, with a primary focus on pharmacology and safety studies. As a domestic nonclinical CRO, Bozo performs studies using multiple species—mice, rats, guinea pigs, hamsters, rabbits, dogs, nonhuman primates (NHPs), and miniature pigs—as well as various cell-based systems.

Examples of Non-clinical Studies by Sekisui Medical

No case studies are currently listed on the official website.

Corporate Information —Sekisui Medical

Sekisui Medical operates the diagnostic testing business, the pharmaceutical and enzyme business, and the drug discovery support business. The company also manufactures and sells in vitro diagnostic products, provides contract manufacturing of enzymes for biopharmaceuticals, and supports new drug development.By delivering high-quality products and services that meet the needs of the healthcare industry, Sekisui Medical helps advance healthcare.