Immunogenicity (IG) testing is a crucial part of biopharmaceutical development. Stringent recommendations regarding the development and validation of anti-drug antibody (ADA) assays necessitate more robust and tolerant methods. The application of MSD’s MULTI-ARRAY technology for ADA testing has gained prominence in recent years based on increased sensitivity, large dynamic range, and greater therapeutic tolerance [Dai (2014) and Kim (2015)].

MSD products support every phase of immunogenicity testing with:

• Superior sensitivity in detecting low- and high-affinity ADAs
• Exceptional intra- and inter-assay precision
• Minimal matrix interference
• Flexible platform that supports most protocols including cell-based NAb
• High drug tolerance that minimizes ADA-drug complex interference
• Wide dynamic range that reduces sample dilutions

Immunogenicity Products

MSD offers an extensive portfolio of assay development kits, plates, and reagents for every stage of biotherapeutic development. MSD products are qualified through rigorous multi-lot testing for reproducibility and precision, and demonstrate exceptional intra-lot and inter-lot consistency.

Products include:

• MSD GOLD Streptavidin Plates - the industry standard for assay performance, consistency, and convenience
• MSD GOLD SULFO-TAG Conjugates - easy to prepare, stable, and result in highly sensitive detection
• MSD GOLD Read Buffer - ready-to-use MSD GOLD Read Buffer delivers even greater lot-to-lot consistency
• ELISA Conversion Packs and U-PLEX Development Packs - extensive development tools that enable users to design custom immunoassays

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Immunogenicity Services

MSD Services provide solutions to challenging immunogenicity studies, including the creation of custom assay plates, conjugated antibody or drug reagents, and neutralizing antibody (NAb) assays.  Contact us to discuss your needs. 

Services include:

• Conjugation -  leverage our expertise and knowledge in reagent manufacturing for conjugating biomolecules with either biotin or SULFO-TAG for use on our platform. MSD Services characterizes your conjugates and routinely provides a certificate of analysis. 

• Assay Development - utilize MSD's experienced scientists to develop high-quality assays for your immunogenicity applications

• Prototype Printing – custom-designed MSD plates printed with materials of your choice, shipped ready to use 

Immunogenicity Guidelines

FDA guidelines suggest the use of a multi-tiered approach to best manage the large number of immunogenicity tests prescribed by a biotherapeutics study plan. Initial screening assays must be highly sensitive to enable detection of low levels of ADAs. Positive samples are then run in a confirmatory assay to eliminate false-positive results. Lastly, further characterization of the ADA, including cell-based neutralizing antibody assays, is performed to determine functionality.


Below are selected immunogenicity references for further reading.  View the References tab for additional references.

Title	Journal	Year
Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products	FDA Draft Guidance	2016
Comparison of immunogenicity test methods used in clinical studies of infliximab and its biosimilar (CT-P13)	Expert Rev. Clin.	2015
Recommendations for the development and validation of confirmatory anti-drug antibody assays	EMA Guidelines	2015
Guideline on Immunogenicity assessment of biotechnology-derived therapeutic proteins	J Biopharm Stat.	2015
Statistical evaluation of several methods for cut-point determination of immunogenicity screening assay	Bioanalysis	2015
Development of a Method That Eliminates False-Positive Results due to Nerve Growth Factor Interference in the Assessment of Fulranumab Immunogenicity	AAPS	2014
Bridging Immunogenicity Assays - Guidelines for Assay Development	MSD Guidelines	2011
Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products	J Pharm Biomed Anal.	2008
Recommendation for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products	J Immunol Methods.	2004