Immunogenicity / Immunotoxicity Assessment

Assess early your biotherapeutic drug candidate’s immunogenicity potential

Regulators (for example, the US Food and Drug Administration and European Medicines Agency) require the provision of data on the assessment of your biotherapeutic proteins because they have the potential to elicit an immune response when administered to humans. Our immunogenicity and immunotoxicity assessment services address the challenge of unwanted immune responses throughout the drug development cycle. By managing potential drug immunogenicity at the earliest possible stage (starting with only the amino acid sequence), you can save time and money while creating a safer, more effective biotherapeutic protein for the market.

The patient’s immune response to a biotherapeutic protein is usually determined by measuring the levels of antibodies directed against the protein, known as anti-drug antibodies (ADA). The consequences of generating unwanted ADA may include partial or complete loss of drug efficacy, altered pharmacokinetics/pharmacodynamics or, in some cases, cross reaction with endogenous proteins. In certain situations, these effects can even result in life-threatening reactions.

Download our Q&A on Immunogenicity and Immunotoxicity

Immunogenicity assessment

The good, the bad (and the ugly)