Understanding your molecule's immunogenicity potential early reduces the likelihood of later development issues

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.

Our Epibase® suite of in silico immunoprofiling services and in vitro cellular assays predict and compare the immunogenicity risk potential of the biotherapeutic protein to other lead candidates and over 500 known protein sequences. Our Applied Protein Services (APS) experts will work with you to customize your assessment strategy based on your therapeutic goal and timeline. Epibase® in silico and in vitro platforms provide the most comprehensive immunogenicity assessment package offered.

If you’re performing immunogenicity studies in house, we also supply a full line of immune cells including PBMCs, dendritic cells, and purified T-cells cryopreserved in ready-to-use formats with dozens of donors to choose from.  

The Good, The Bad, And The Ugly: How Does Identifying And Mitigating Potential For Immunogenicity And Immunotoxicity De-Risk And Accelerate Your Drug Development?

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“Lonza’s Epibase® in silico immunogenicity assessment supported our antibody engineering which enabled us to evaluate the technology more appropriately. The assessment didn’t add significant time to our project and the Lonza team was very responsive and provided valuable input on our project”
-Sysmex Corporation

Immunogenicity services for biotherapeutics

We offer in silico and in vitro assessment services to screen biotherapeutic and vaccine candidates for their immunogenicity potential. Our Epibase® tools help predict the immunogenicity of candidates thereby promoting knowledge-based decisions regarding candidate selection in the early discovery and development phases. The tools can also aid in the monitoring of immunogenicity during clinical phases.

The safety and efficacy of biological candidates are critical to their clinical success. Learn how we can help.

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Immunogenicity risk assessment: Using pre-clinical tools during lead selection and optimization.