The Importance of Reliable Immunogenicity Assays For Biologics
A key aspect of developing your biologic is accurately assessing whether or not it is immunogenic or can cause an immune response. Biologics, such as antibodies, peptides and recombinant proteins, have the potential to induce an anti-drug antibody (ADA) response, which can cause allergic or anaphylactic reactions, reduction in efficacy, or induction of autoimmunity.
This range of potential adverse responses due to immunogenicity makes assessing it a critical part of the drug development process, often required for approval by the U.S. Food and Drug Administration (FDA) and The European Medicines Agency (EMEA).
Eurofins’ bioanalytical experts can help you decide the best way to assess immunogenicity of your biologic using a comprehensive suite of immunogenicity assays. Our Good Laboratory Practice (GLP)-compliant laboratory can match the scale required for your project.
Our GXP Lab Services
The development and validation of immunogenicity assays is constantly evolving. Our GXP lab services are cognizant of the latest developments in this area, so that we can best help you to accelerate your drug discovery and development programs.
Adhering to current FDA and EMEA guidelines, we follow a stepwise approach to measure ADA responses using a multitude of reliable assays, including:
- ELISA (single- and multi-plex)
- Electrochemiluminescence (ECL)
- DELFIA
- Cell-based Neutralizing Antibody Assay (NAb)
Learn More About The Instruments We Use
Factors affecting immunogenicity include:
- Similarity to self proteins
- Glycosylation status
- Excipients
- Route of administration
- Dosing schedule
- Target
Our Philosophy
No biologic is created equal. Therefore, there is no “one size fits all” way to assay immunogenicity.
We take a stepwise approach to measuring ADA responses using a variety of instrumentation platforms, each with their own optimal use. Whether we are helping you develop and validate assays, analyze samples, or transferring previously developed methods, Eurofins can choose the assays and instruments necessary for accurately and reliably assessing immunogenicity.
