Anti-drug Antibody Preparation

• Immunogenicity refers to the immune response generated by the immune system against drugs entering the human body. The immune response produces anti-drug antibodies (ADA) that specifically bind to drug molecules. In the process of drug development, especially for macromolecular drugs, small molecule and peptide drugs, and even related adjuvants, they may directly or indirectly cause a large immunogenic reaction. Mild reactions may lead to the termination of projects in the preclinical or clinical stages, resulting in the loss of early economic investments. Severe reactions may reduce drug efficacy, cause allergic reactions, and even pose a threat to animal safety.
  According to current FDA guidelines, all serious immune responses, including acute hypersensitivity and neutralizing antibody responses, must be excluded during drug development. Therefore, ADA (Anti-Drug-Antibody)—effective detection in PK research, that is, systematic and scientific completion of ADA detection is an urgent issue in PK research.
  The evaluation of immunogenicity is mainly carried out by an anti-drug antibody (anti-drug antibody, ADA) analytical method. In order to effectively evaluate the immunogenicity of antibody drugs in preclinical and clinical research, it is particularly important to develop reliable ADA assessment and detection methods. Analytical techniques include ELISA, ECL, SPR, RIA, MSD, etc., and one or several combinations can be flexibly adopted. Currently, the most commonly used techniques are ECL and MSD.
  High-sensitivity and diverse polyclonal anti-drug antibodies can be used as a positive references in immunogenicity studies, simulating the situation of ADA production in the human body. They can also specifically detect the level of antibody drugs in the body, making them important reagents for pharmacokinetic studies. Therefore, as essential tools in the development of antibody drugs, anti-drug antibodies are not only indispensable for clinical applications but also widely used in clinical stages.
  Medicilon has rich experience in ADA development and has successfully delivered more than 100 projects. Medicilon can provide high-affinity and specific polyclonal anti-drug antibody development services with short development cycles and low costs.

Development process

• （1）Antigen preparation
  Antigen detection (1-2 days)Antigen review Antigen preparation (2 weeks)Conjugation or enzymatic cleavage of the full-length antibody drug provided by the client.
• （2）Immunization and serum testing
  Immunization and serum titer testing (8 weeks)Blood collection before immunization, animal immunization, titer testing, final blood collection, provide immunization schedule and titer test report; titer meets ≥1:729,000        
• （3）Antibody purification
  Antibody purification (2 weeks)Protein A purificationAntigen affinity chromatographyTotal human IgG de-cross-purified (optional)Other proteins to cross-purify (optional)        
• （4）Antibody detection
  Antibody identification (1 week)SDS-PAGE purity analysis, UV concentration determinationTotal human IgG cross-reactivity;<2% cross-reactivity
• （5）Delivery
  Delivery (12 weeks)Purified antibody, titer ≥1:243,000, quantity (optional)COAProject Development Detailed Report        

Advantage

• Rich experience: More than 10 years of service development experience, one-to-one communication to customize projects, real-time feedback on experimental situations.Various types: Full-length antibodies, antibody fragments, small molecule drugs, peptide drugs, ADC drug conjugates, vaccines, etc.High quality:Guaranteed delivery sensitivity, cross-reactivity meeting regulatory requirements for PK/ADA detection antibodies.Various purification methods:Protein A/G, antigen affinity, Human IgG, isotype IgG, interfering protein, etc.

Case

• Case 1-ADC Drug

  

  
  

  Serum titer

  

  
  

  Antibody titer after purification

• Case 2-Antibody drug human IgG decrossover

  

  
  

  Serum titer

  

  
  

  Antibody titer after purification

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