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Immunogenicity testing is a crucial part of biopharmaceutical development. More stringent recommendations regarding immunogenicity assay performance necessitates the development of more robust and tolerant assays. MSD assays exhibit excellent sensitivity, precision, free drug tolerance, and minimal matrix effects. In addition, MSD assays are capable of finding low affinity antibodies during initial screens, and have a large linear range that reduces the number of required sample dilutions. Build assays for many drug types using MSD technology, including antibodies, humanized antibodies, proteins, and peptides with reagents designed to provide a variety of flexible assay formats and facilitate rapid assay development. Comparisons of MSD immunogenicity assays to the traditional ELISA format are featured below, using both a bridging assay format and direct immobilization format.
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MSD assay shows comparable sensitivity to ELISA, with a larger dynamic range and a simple homogenous incubation.
MSD Bridging Assay Protocol
- Combine biotin-drug, sTAG-drug and sample in polypropylene plate and incubate for 1 hour to overnight.
- Transfer solution to pre-blocked standard streptavidin MSD plate. Incubate for 1 hour.
- Wash assay plate; add Read Buffer T; read plate on SECTORTM instrument.
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Neat human serum was used as the sample matrix. The top of the curve is about 1 mg/mL for both formats, but the MSD format is 40 times more sensitive.
MSD Sandwich Immunogenicity Assay Protocol
- Coat plate with drug at 0.05 to 5 pmole per well and incubate for 1 hour to overnight.
- Add 150 µL/well of Blocking Solution and incubate for 1 hour.
- Wash plate. Add 25 µL of sample.
- (Optional wash). Add 25 µL of detection antibody.
- Wash assay plate; add Read Buffer T; read plate on SECTOR instrument.
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Immunogenicity
