Monoclonal antibody (mAbs) drugs have been widely used in autoimmunity, tumors, transplant rejection, viral infections and other diseases due to their advantages of high specificity, good uniformity, high sensitivity, and mass production. Monoclonal antibody drugs occupy an increasing share of the biopharmaceutical market. More and more companies have joined the production of monoclonal antibody drugs. In order to ensure the safety and effectiveness of monoclonal antibody drug products and promote orderly and benign R&D and competition in this field, relevant regulatory authorities continue to put forward new requirements for the characterization, analysis and quality control of monoclonal antibody biotherapeutics.
Monoclonal antibody drugs require in-depth characterization to obtain approval for clinical trials and subsequent sales. The current quality standards of monoclonal antibody drugs mainly refer to the relevant technical guidelines of International Conference on Harmonization of Registration Pharmaceuticals for Human Use (ICH), Food and Drug Administration (FDA), United States Pharmacopoeia (USP) and European Pharmacopoeia (EP).
The inspection items can be divided into:
1) General inspection, such as appearance, color, turbidity, visible foreign matter, etc.;
2) Physical and chemical inspection, such as moisture, pH, osmotic pressure, extinction coefficient, insoluble particles, etc.;
3) Purity and impurity analysis, such as protein purity determination, molecular size variants, charge variants, product-related impurities, process-related impurities;
4) Content determination, such as protein content determination;
5) Identification and consistency analysis, such as analysis based on molecular structure and (or) other unique attributes;
6) Potency analysis, such as biological activity and binding activity.
Creative Proteomics can provide you with monoclonal antibody characterization services. We will provide you with the physical, chemical and structural characteristics, purity, impurities, content and other tests of monoclonal antibodies in strict accordance with various quality standards.
Monoclonal Antibody Characterization Service We Can Provide:
|Complete monoclonal antibody analysis||Determination of molecular weight (including complete monoclonal antibodies and light and heavy chains, Fab fragments, Fc fragments, etc.)|
|Annotation of monoclonal antibody glycoforms|
|Charge isoform analysis|
|Peptide fingerprints and post-translational modification sites analysis||Determination of amino acid sequence coverage|
|Post-translational modification site identification and occupancy analysis (oxidation, deamidation, N-terminal pyroglutamic acid cyclization, glycosylation, etc.)|
|Confirmation of disulfide bonds|
|Monoclonal antibody drug glycoform analysis||Identification of glycoforms|
|Quantification of glycosides|
|Other Service||Mass Spectrometry based Epitope Mapping|
|Surface Plasmon Resonance (SPR) Service|
Creative Proteomics is equipped with many advanced technologies such as nuclear magnetic resonance, hydrogen deuterium exchange, ion mobility mass spectrometry, and other mass spectrometry that can provide multiple information to characterize the advanced structure of the key quality attributes. We also have transmission electron microscopy, X-ray diffraction, and size exclusion chromatography coupled with multi-angle laser light scattering to identify and characterize monoclonal antibody drug aggregates.
Creative Proteomics is looking forward to cooperating with you. We will provide customized solutions. We are confident to provide you with technical support related to drug development, production process and other special requirements. If you have other questions, please feel free to contact us.