Comprehensive support for characteristic analysis using analysis equipment managed in accordance with GMP regulations.
Our company can conduct characterization analysis of biopharmaceuticals using analytical instruments managed in compliance with GMP regulations. We provide characterization analysis services based on the ICH-Q6B guidelines, "Specifications and Test Methods for Biopharmaceuticals (Biotechnology-derived Products / Biological Origin Products)." Please refer to the basic information for the analysis items. 【Features】 ■ Comprehensive support for the characterization analysis of biopharmaceuticals ■ Consistent contract services from test method development to quality testing for biopharmaceuticals ■ Possession of analytical instruments managed in compliance with GMP regulations For more detailed information, please see the "Related Links." If you have any questions or inquiries, please feel free to contact us through the "Contact Us" section on this page or through the "Contact Form" on our official website.
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basic information
【Analysis Items】 1. Physicochemical Properties ■ Terminal Amino Acid Sequence / Amino Acid Sequence (Primary Structure) ■ Post-Translational Modifications - Disulfide Bonds, Other Post-Translational Modifications - Free Thiol Analysis - Drug-Antibody Ratio of Antibody-Drug Conjugates - PEGylated Proteins ■ Glycans - Glycan Quantification - Glycan Structure Analysis - Glycan Binding Site Analysis ■ Molecular Weight / Molecular Size Intact and Subunits ■ Higher-Order Structure Secondary Structure, Thermal Stability, Unfolding 2. Biological Activity Cell Culture Bioassays (CBA), Biochemical Tests 3. Immunochemical Properties ELISA, Western Blot 4. Purity, Impurities, Contaminants ■ Impurity Evaluation (Derived from Target Substance) - Fragments - Variants (Deamidated Forms, Charge Variants, Disulfide Bond Mismatch Forms, Oxidized Forms, Complex Proteins, etc.) - Aggregates ■ Impurity Evaluation (Derived from Manufacturing Process) - Host Cell-Derived Proteins - Nucleic Acids - Residual Protein A - Surfactants (Poloxamer, Antifoam, etc.) ■ Contaminants - Microorganisms - Particle Analysis 5. Amount of Substance Protein Concentration: UV-Visible Absorbance Measurement, SoloVPE
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Company information
We are a contract analysis laboratory (Kyoto) that complies with pharmaceutical GMP standards, part of the Eurofins Group, which operates a global contract analysis business. We efficiently and swiftly respond to various testing needs from the early stages of product development to commercialization, while adhering to various regulations. Please feel free to contact us if you have any requests.
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