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Abstract

Immunogenicity is an important factor in determining the success of human therapeutic proteins and may not be adequately predicted based on the currently available animal models. There are many variables that affect a protein's immunogenicity, including oxidation, aggregation, purification, storage, route and frequency of administration, and the immune status of the patient population.

There are multiple platforms available to support immunogenicity assessment and it is important to choose and validate the appropriate platform for detecting the antibodies to each protein. Knowing the limitations and capabilities of the testing platform used in the immunogenicity assessment helps in the understanding of what the reported immunogenicity of a therapeutic agent means for the patient. Once an immune response is identified, the characterisation of that immune response, including concentration, isotype(s), affinity and neutralising capability can be very informative. The clinical relevance of antibodies against therapeutic proteins can be determined by monitoring the effect of the antibodies in patients. As immunogenicity assessment becomes more thorough, we are gaining valuable information to help in the development of safe and efficacious protein therapeutics.