Quality testing of antibody drugs

Quality inspection of antibody drugsAntibody testing refers to the protective proteins produced by the body due to antigen stimulation. It (immunoglobulin is not just an antibody) is a large Y-shaped protein secreted by plasma cells (effector B cells) and used by the immune system to identify and neutralize foreign substances such as bacteria, viruses, etc. It is only found in the blood and other body fluids of vertebrates, as well as on the cell membrane surface of their B cells.

Quality testing of antibody drugsAntibody drugs are drugs composed of antibody substances. Quality analysis of antibody drugs is the identification of key quality attributes that affect the efficacy of antibody drugs, mainly including structure (molecular weight, primary sequence, secondary structure, etc.), oligosaccharide distribution, heterogeneity (molecular size/charge heterogeneity), activity, and impurities. Among them, activity assay is the determination of the active ingredients, content, and potency of drugs, which is an important quality control indicator to ensure the effectiveness of antibody drugs. For antibody conjugated drugs, DAR (Drug Antibody Conjugate Ratio) is also an important quality control indicator.

Immunogenicity may be non neutralizing or neutralizing. Non neutralizing immunogenicity may not have adverse effects on the pharmacological properties of drugs, while neutralizing immunogenicity may inactivate drug activity, alter drug clearance, plasma half-life, and tissue distribution. Therefore, immunogenicity testing is important for the safety and effectiveness of products.

The evaluation of immunogenicity is mainly carried out through the analysis of drug-resistant antibodies. It is particularly important to develop reliable assessment and detection methods for ADA in order to effectively evaluate the immunogenicity of antibody drugs in preclinical and clinical studies. Analytical techniques include ELISA, ECL, SPR, RIA, MSD, etc., which can flexibly adopt one or several combinationsPreviously usedThe techniques used are ELISA and MSD. The experimental design is a multi-step detection method, including screening, confirmation, titer, and neutralization tests: