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Sumika Chemical Analysis Service, Ltd.

Table of Contents

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

3 Specialized Pre-clinical CROs for Advanced Drug Discovery

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.

Reference: Sumika Chemical Analysis Service, Ltd. official websitehttps://www.scas.co.jp/services/lifescience/pharmaceuticals/concentration/new-modality.html

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.

Address	4-6-17 Koraibashi, Chuo-ku, Osaka-shi, Osaka (Osaka Head Office); 9F Sumitomo Fudosan Hongo Building, 3-22-5 Hongo, Bunkyo-ku, Tokyo (Tokyo Head Office)
Tel	06-6202-1810 (Osaka Head Office), 03-5689-1211 (Tokyo Head Office)
Website	https://www.scas.co.jp/

3 Recommended Contract Research Organizations for Non-Clinical Studies
— by Target goal and Expertise

In drug discovery, the quality and efficiency of non-clinical studies have a direct impact on clinical success rates, development costs, and overall length of time required in R&D. In recent years, there has been more demand for clinically relevant data, globally accepted reliability, and accurate early-stage screening. Thus, it is more important than ever to select the right CRO (Contract Research Organization) for strategic approach.
In this article, we highlight three CROs with proven technical capabilities, expertise, and long standing track records. These are our TOP 3 choices based on their capabilities and the specific target goals of the researchers for their non-clinical studies.

Pharmacology (Efficacy) Studies
Replicate unknown pathological models and
Discovery to clinically oriented drug evaluation

SMC Laboratories, Inc.

Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/jp/)

SMC Laboratories, Inc. has established a disease models using patented mouse technologies. The company has established proprietary pathological models—particularly in liver disease and fibrosis—and continues to expand their approach across a wide range of models in cancer, inflammation, and metabolic diseases.
From exploratory research to clinically oriented efficacy evaluation, SMC offers customized study designs, dosing strategies, and evaluation analysis tailored to each project. Their collaborative approachallows researchers to discuss and refine study plans together with SMC’s expert scientists.
With flexible small-scale study options and strong technical support, SMC Laboratories, Inc. is an ideal partner for start-ups, biotech ventures, and academic institutions alike.

Consult study design and disease model development
with SMC Laboratories, Inc.

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Safety Studies
Comprehensive Safety Evaluation for FIH Applications

Labcorp Holdings Inc.
(Labcorp Drug Development)

Reference: Labcorp Holdings Inc. official website (https://jp.labcorp.com/)

Labcorp Holdings Inc. provides a fully integrated GLP testing system aligned with international regulatory standards, including FDA, EMA, and PMDA requirements. All studies are conducted under ICH-compliant quality assurance, making it ready for data submission.
The company has extensive expertise in long-term toxicity studies such as Segment I–III reproductive and carcinogenicity studies, as well as 2-year chronic toxicity assessments.
Labcorp Holdings Inc.’s comprehensive approach enables sponsors to efficiently outsource the entire preclinical package from toxicology, toxicokinetic (TK), and safety pharmacology study design to execution. This accelerates a path to First-in-Human (FIH) trials. For most of the global drug developers, this all-in-one service structure minimizes cost, risk, and expedite the time before advancing to clinical phase.

Consult Labcorp Holdings Inc.
Discuss GLP/ICH-compliant study design for your FIH submission.

To labcorp.
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Pharmacokinetic (PK/PD) Studies
High-Precision Bioanalysis for Clinically Predictive PK/PD Evaluation

PhoenixBio Co., Ltd.

Source: PhoenixBio Co., Ltd. Official Website (https://phoenixbio.co.jp/)

PhoenixBio Co., Ltd.offers pharmacokinetic and hepatic metabolism studies using their proprietary PXB-mouse®, a humanized-liver chimeric mouse model. This platform enables the acquisition of data with high clinical correlation in ADME, drug–to-drug interaction studies, bridging the gap between preclinical and clinical stages.
With advanced LC-MS/MS-based bioanalysis, PhoenixBio Co., Ltd. provides aseamless workflow from plasma concentration measurement and metabolite identification to quantitative validation.
The company offersan integrated evaluation analysiscovering pharmacokinetics, hepatotoxicity, and safety with flexibility to accommodate complex modalities such as oligonucleotide and middle-molecule therapeutics. For compounds where hepatic metabolism is a development bottleneck—or where quantitative, reproducible exposure data are critical—PhoenixBio Co., Ltd. delivers unmatched analytical precision and consistency.

Consult Phoenix Bio for PK/PD analysis with a clinical focus

Phoenix Bio.
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