Wide Range of Bioanalysis and Immunogenicity Assessment Services for Large-Molecule Drugs
Sumika Chemical Analysis Service, Ltd. (SCAS) provides a wide range of bioanalysis and immunogenicity assessment services for large-molecule drugs (large molecules), including antibodies, glycoproteins and antibody-drug conjugates (ADCs) in biological matrices. We support your analytical method development and validation, and sample analyses in nonclinical and clinical studies, encompassing pharmacology, pharmacokinetics and safety assessments, in accordance with global regulatory requirements.
Features
- For ligand binding assays (LBA), we perform both traditional enzyme-linked immunosorbent assay (ELISA) and highly sensitive electrochemiluminescence (ECL) method.
- At our immunogenicity assessments an acid dissociation technique is used to enhance drug tolerance during anti-drug antibody (ADA) detection.
- All in vivo bioanalytical method validations and sample analyses are conducted in compliance with applicable regulations, including GLP and ICH M10 guidelines.
- We utilize LC-MS/MS analysis because it is particularly advantageous when antibody reagents for LBA are unavailable and when samples need to be analyzed in the presence of concomitant antibodies.
Service Menu
We provide analytical method development and validation, and sample analysis (including preparation of labeled antibody for LBA). Analytical targets include antibodies, glycoproteins, ADCs, anti-drug antibodies (ADAs), neutralizing antibodies (nAbs) and anti-host cell protein (HCP) antibodies. Representative analytical platform for large molecules is described below.
Regulatory Compliance
- All method validations and sample analyses are conducted in accordance with GLP and the ICH M10 guideline.
- Analytical testing includes quantification of drug concentrations in plasma, urine, and tissues, as well as immunogenicity assessments through ADA detection, followed by evaluation of nAb activity.
- Analytical software utilized includes Phoenix WinNonlin, JMP and others.
Track Record
Over the past three years, SCAS performed more than 200 studies for nonclinical and clinical phases, primarily for pharmaceutical companies worldwide.
Representative Analytical Platform for Large Molecules
| Method | Features | Sample Types Analyzed | Instruments (In-house) |
|---|---|---|---|
| ELISA | High throughput, high versatility | Antibodies, glycoproteins, ADCs, nAbs, anti-HCP | Gyrolab xP workstation (GYROS PROTEIN Technologies) |
| Microplate reader (SpectraMaxⓇ i3x) | |||
| SpectraMaxⓇ ABS Plus (Molecular Devices, LLC) | |||
| Simple Plex (EllaTM, Protein Simple) | |||
| ECL | High sensitivity, wide dynamic range | Antibodies, glycoproteins, ADCs, nAbs, anti-HCP | QuickPlexⓇ SQ120 (Meso Scale Diagnostics, LLC) |
| SPR | Label-free, ADA binding affinity profiling | ADA (anti-drug antibody) | BiacoreTM T200 (Cytiva) |
| Cell-based | Neutralizing antibody activity assessment | ADA (neutralizing) | Microplate reader (SpectraMaxⓇ i3x, ABS Plus) |
| LC-MS/MS | No need for antibody reagents | Antibodies, ADCs | Triple QuadTM 7500 (AB Sciex Pte. Ltd.) |
Abbreviations: ELISA (Enzyme-Linked Immunosorbent Assay), ECL (Electrochemiluminescence), SPR (Surface Plasmon Resonance), Cell-based Assays, LC-MS/MS (Liquid Chromatography–Tandem Mass Spectrometry)
References
- GLP (MHW Ordinance No. 21): "Ministerial Ordinance on Criteria for Conducting Nonclinical Studies on Drug Safety"
- GCP (MHW Ordinance No. 28): "Ministerial Ordinance on Criteria for the Conduct of Clinical Trials on Drugs"
- Pharmaceuticals and Medical Devices Agency: "ICH M10 Bioanalytical Method Validation and Sample Analysis," <000272440.pdf>, accessed 2025.11.28
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