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Immunogenicity Test

Compared with normal human antibodies, the antibodies screened by hybridoma platform or antibody library technology are significantly different in structure because these antibodies are all non-humanized antibodies. Therefore, when we inject these antibodies into the human body, the human body may recognize them as a foreign immunogenic substance and produce a certain degree of immunogenic response. When the immunogenic reaction reaches a certain level, it may endanger the health of the subject and even endanger their life.

The immunogenic response is accompanied by the production of anti-drug antibodies (ADA) in the body. Therefore, the detection and analysis of the anti-drug antibodies that may be contained in the serum samples of the subjects can help us to know the existence and severity of the immunogenic reaction after the drug is injected into the human body.

ADAs are divided into non-neutralizing anti-drug antibodies and neutralizing anti-drug antibodies (Nab) that can neutralize the active site of the drug. Analysis of the presence or absence of Nab in ADA and the magnitude of the neutralizing activity of neutralizing antibodies can help us learn the effective retention of drug active sites after drug injection into the human body.

Analytical Methods

Anti-Drug Antibodies(ADA)

  1. ELISA-based bridging method without acidification extraction process (optional when the requirements for method resistance to drug interference are not high)

  2. Bridging method based on ELISA with acidification extraction process (ACE)

  3. The MSD-based Master Mix method (which has strong anti-drug interference ability and saves time and effort)

Neutralizing Antibodies(Nab)

  1. Non-cellular neutralizing antibody detection method

  2. ELISA-based competitive binding method 

  3. The meso-scale discovery (MSD)-based competitive binding method

  4. Cell-Based Neutralizing Antibody Detection Method

  5. Cell functional experiments that introduce a competitive response mechanism (CDCADCCcell proliferation inhibitionendocytosisreporter gene method)