MESO SCALE DISCOVERY® has been intimately involved in the field of immunogenicity as guidelines for assay development have emerged. Over the past five (5) years, MSD has worked with the leaders in biotherapeutics to fine-tune MULTI-ARRAY® technology to meet the needs of the community. Leaders choose MSD for immunogenicity assays over other methods for its many advantages:
- Increased sensitivity enables the detection of low affinity antibodies, improved free drug tolerance, and resistance to matrix effects
- Higher binding capacity in comparison to ELISA (10-100 fold)
- Flexible assay formats enable immunogenicity testing of many drug types including antibodies, proteins and peptides
- Rapid assay development makes the assay more cost and time efficient
- Knowledgeable field applications scientists offer training and immunogenicity assay development support
- Corporate priority to the customers within immunogenicity community – Manufacturing process and business practice improvements in response to customer feedback
- CRO availability – The leading CROs are enabled with MULTI-ARRAY technology
Assay development materials and kits are available from MSD that provide superior solutions for assays and experiments commonly used for biotherapeutic safety and efficacy studies including:
- Bridging Immunogenicity Assays
- Drug Tolerance Assays
- Neutralization Assays
- Pharmacokinetics
- Pharmacodynamics
High quality MULTI-ARRAY Streptavidin and High Bind Avidin Gold plates are now available to help you evaluate the immunogenicity of therapeutic agents. The plates are sold individually and as part of our ELISA Conversion Pack III and Immunogenicity Development Pack which include all the necessary components for assay development.
The following citations from leaders in biotherapeutic development highlight the use of MULTI-ARRAY plates in immunogenicity assessment.
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Tatarewicz, S., Miller, J.M., Swanson, S.J., Moxness, M.S. (2010) Rheumatoid factor interference in immunogenicity assays for human monoclonal antibody therapeutics.J Immunol Methods. Vol. 357(1-2):10-6. |
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Liang, M., Klakamp S.L., Funelas, C., Lu, H., Lam, B., Herl, C., Umble, A., Drake, A.W., Pak, M., Ageyeva, N., Pasumarthi, R., Roskos, L. (2007)Detection of High- and Low-Affinity Antibodies Against a Human Monoclonal Antibody Using Various Technology Platforms.Assay and Drug Dev Technol. Vol. 5(5): 1-8. |
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Moxness, M., Tatarewicz, S., Weeraratne, D., Murakami, N., Wullner, D., Mytych, D.,Jawa,V., Koren., E.,Swanson, S. (2005) Immunogenicity Testing by Electrochemiluminescent Detection for Antibodies Directed against Therapeutic Human Monoclonal Antibodies.Clinical Chemistry. 51:1983-1985. |
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White, J.T., Martell, L.A., Van Tuyl, A., Boyer, R., Warness, L., Taniguchi, G.T., Foehr, E. (2008) Development, Validation, and Clinical Implementation of an Assay to Measure Total Antibody Response to Naglazyme(R) (Galsulfase).AAPS Journal. Vol. 10(2):363-72. |
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Lu, Y., Young, J., Meng, Y.G. (2007) Electrochemiluminescence to detect surface proteins on live cells.Current Op Pharmacology. Vol. 7:541-546. |
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Lu, Y., Wong, W.L., Meng, Y.G. (2006) A high throughput electrochemiluminescent cell-binding assay for therapeutic anti-CD20 antibody selection.J Immunological Methods. Vol. 314(1-2):74-9. |
For a complete list of citations using MSD technology for immunogenicity assessment, visit the MSD Bibliography page.
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Visit our booth or attend a learning session.
- 2012 Immunogenicity for
Biotherapeutics Conference
April 17 - 19, 2012 - Baltimore, MD
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