Biological Products Analysis

    Drugs with biological origins are still the mainstream treatments for many diseases. These drugs include antibodies, recombinant proteins, vaccines, etc. With technological progression and expending demands, hundreds and thousands of new biopharmaceutical drugs have been developed each year. However, successful development of these drugs relies on ensuring the quality, potency, and safety of your biopharmaceutical product, as impurity and defection of these biopharmaceutical products may compromise the efficacy and place potential risks when applied in clinical stage. Therefore, evaluation of biopharmaceuticals is critical and necessary before clinical trials. To help solve the challenges in the developmental process of biopharmaceutical products, MtoZ Biolabs has established a comprehensive analytical platform for biopharmaceutical analysis, and is able to cover most biopharmaceutical related requirements. We strictly follow the International Conference on Harmonisation (ICH) guidelines of technical requirements for registration of pharmaceuticals for human use.

    Technical Platforms

    • Capillary Isoelectric Focusing
    • 2D-DIGE
    • Size Exclusion Chromatography (SEC)
    • High Performance Liquid Chromatography (HPLC)
    • Reversed-phase Chromatography (RP)
    • MALDI-TOF-MS/MS
    • ESI-TOF-MS/MS
    • Native MS
    • Hydrogen-deuterium exchange (HDX) MS

    Identification of Biopharmaceuticals

     

     

     

     


    Variation Analysis of Biopharmaceuticals

     

     

     

     


    Purity Analysis of Biopharmaceuticals

     

     

     

     


    *Apart from the above services, we can also provide customized service for other types of biologics and biopharmaceuticals. You are welcome to contact us for specific requirement related to these biopharmaceuticals.

    Key Features

    • Free consultation and experimental design
    • Well-established analytical platform & comprehensive range of technologies
    • Full-package service for proteins/antibody/vaccines
    • Professional data analytical system
    • Support custom service

    Application Areas

    • Antibody analysis
    • Antibody-drug-conjugates (ADCs) analysis
    • Protein/peptide analysis
    • Vaccines analysis
    • PEGylated proteins analysis
    • Glycan analysis

    Related Services

    Metabolomics

    Targeted Metabolomics
    Untargeted Metabolomics
    Lipidomics

    Quantitative Proteomics

    Label-Free
    iTRAQ/TMT
    SILAC/Dimethyl
    SWATH
    MRM

    Protein Analysis

    Protein Identification
    Protein Mass Measurement
    PTMs Identification

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