Sumika Chemical Analysis Service, Ltd.

Sumika Chemical Analysis Service, Ltd. has more than 30 years of experience measuring drug concentrations in biological samples for nonclinical and clinical studies. The following introduces the features of its nonclinical studies, examples of disease models, and case studies to support agency selection for nonclinical work.

Non-Clinical Studies by Sumika Chemical Analysis Service, Ltd.

Advanced bioanalysis technology and a diverse service portfolio

The institute employs state-of-the-art platforms such as LC-MS/MS and the Gyrolab xP workstation to support a broad range of assays. Its capabilities include concentration measurement of small-molecule drugs and large molecules (antibodies, glycoproteins, ADCs, etc.) in biological samples; LC-MS/MS method development and measurement for antibody drugs, ADCs (antibody–drug conjugates), peptide therapeutics, and nucleic acid therapeutics; concentration measurement of biopharmaceuticals; measurement of investigational and concomitant drugs in clinical drug–drug interaction (DDI) studies; biomarker measurement and exosome research support; and quantitative analysis using fully automated ELISA systems.

Fully compliant with international regulations

It operates in full compliance with applicable domestic and international regulations. Using LC-MS/MS, HPLC, ELISA, and other analytical instruments, it performs method validation and drug concentration measurement in biological matrices with high reliability. Study protocols and reports are available in both Japanese and English to support global drug development.

One-stop solution from method development to measurement

Sumika Analysis provides an integrated, end-to-end solution covering analytical method development, validation, regulatory compliance, and routine concentration measurement. With high-throughput analysis using small sample volumes, rapid method development, and straightforward technology transfer, it delivers reliable, efficient services. By conducting validation and measurement under various regulations quickly and with high quality, it can supply fit-for-purpose datasets at each stage of drug development in a consolidated manner and support efficient project execution

Partner Companies Managed by Sumika Chemical Analysis Service, Ltd.

Nippon Medi-Physics Co., Ltd.

In addition to the manufacture and sale of radiopharmaceuticals, the company conducts contract nonclinical PET imaging studies (e.g., biodistribution assessment and evaluation of therapeutic effects). Leveraging technologies and know-how accumulated over many years in the PET diagnostics business, it provides strong, cross-functional support for the research and development of pharmaceuticals and regenerative medicine products.

Non-Clinical Test Cases at Sumika Chemical Analysis Service, Ltd.

Measurement of protein drug concentrations in biological samples (ECL immunoassay)

provide services to measure protein drug concentrations in biological samples using an electrochemiluminescence (ECL) immunoassay. Using human serum containing the test article as the sample, a capture antibody is immobilized on the assay plate; the analytical sample and a labeled detection antibody are added, and measurement is performed on an ECL instrument. Calibration curves were prepared over the range of 2.74 to 6,000 mU/mL.

Sumika Chemical Analysis Service, Ltd. — Company Information

Since July 1972, following independence from the analytical division of Sumitomo Chemical, the company has supported a wide range of industrial and research fields.