Factors Affecting the Immunogenicity of Biopharmaceuticals

Immunogenic responses, where antibodies are produced by the immune system as a protective response, can adversely affect the pharmacokinetics, bioavailability, and efficacy of biopharmaceuticals, and may even neutralize the activity of the drug.

Many different factors influence the immunogenicity of biopharmaceuticals. Although in most cases, an immune response to a biopharmaceutical has little or no clinical impact, they can pose several potential risks for the patient, particularly in the case of an Anti-Drug Antibody (ADA) and neutralizing antibody (NAb) response.

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Potential pitfalls are summarized and listed according to the increased risk of immunogenic response - use it as a guide of factors to consider when assessing and designing drug compounds.