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
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 Early Development Services 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 are performing immunogenicity studies in house, we can 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.
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