Immunogenicity Analysis

With its many years of experience in applying immunochemical analysis to clinical diagnostics and the research field, Cygnus has assembled a comprehensive menu of reagents and test kits designed to meet the challenges faced by biopharmaceutical companies in development of analytical methods to detect and fully characterize immune responses in patients.

These robust and proven reagents have been developed to overcome many of the non-specific or false positive reactions that often confuse analysis of patient immune responses. Patient antibodies to the therapeutic drug can cause a variety of problems. When patient antibody binds to the drug it may be more rapidly cleared or even neutralized, as has been reported for proteins like insulin, interferon and others to treat hemophilia.

Immunogenicity of the drug gives the potential for significant hypersensitivity reactions and may even progress to the development of auto-antibodies to the patient’s natural version of that protein as has been reported for the recombinant hormone, erythropoietin. Our well characterized immunospecific reagents can be used for the following purposes:

• To establish baseline or pretherapy immune response.
• Detect titer increases, post therapy.
• Screening of patient population to identify those who may have neutralizing antibodies.
• Establish correlation of antibody titer of patient response to therapy.
• Epitope mapping of the immunogenic portion of the drug.
• Distinguish between immunogenicity of the therapeutic drug and the natural form of the protein.
• Distinguish between an immune response to the drug or to the process contaminants such as host cell proteins.
• Specific isotyping and subtyping of antibodies involved in the immunogenic response.