MSD’s wide range of assay development materials and kits provide superior solutions for each stage of development in clinical and pre-clinical applications as compared to traditional methods. MSD assay sensitivity can be up to 1000-fold better than that of ELISAs with a large linear range of 3-4 logs. MSD’s electrochemiluminescence detection technology reduces background signals due to the stimulation mechanism (electricity) being decoupled from the signal (light). MSD assay formats minimize both matrix effects and free drug interference improving both workflow and performance. MSD offers assays and reagents to enhance the performance of many clinical immunology applications, including:

Immunogenicity

Immunogenicity testing is a crucial part of biopharmaceutical development. More stringent recommendations regarding immunogenicity assay performance necessitate the development of more robust and tolerant assays. MSD assays are capable of identifying low-affinity antibodies during initial screens and have a large linear range that reduces the number of required dilutions. Assays can be built 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.

Drug Tolerance

Drug interference in immunogenicity assays from free drug in patient samples can cause false negatives and suppressed signal. The improved sensitivity of the MSD platform produces higher signals and lower backgrounds leading to greater signal to background ratios and detection of low levels of drug or anti-drug antibody complexes. Improved assay sensitivity allows for larger sample dilution, further reducing drug interference.

Neutralization

The MSD technology platform easily facilitates the development of assays for neutralizing antibodies. These assays are a key step in the development and characterization of a biological therapeutic agent as part of the screening process for immune responses to protein and antibody drugs. The versatility of MSD assay development reagents affords the choice of several types of neutralization assays including a receptor binding/blocking assay format and a whole cell-based neutralization assay.

Pharmacokinetics

Pharmacokinetics is the study of the metabolism and action of drugs in the body, with emphasis on time course studies of adsorption, distribution, period of action, and excretion. Pharmacokinetics assays can easily be implemented on the robust MSD platform using our flexible assay development reagents.

Pharmacodynamics

The study of pharmacodynamics examines drug mechanisms of action, as well as their exerted biochemical and physiological effects. These effects can be generated through drug interaction with specific cellular proteins, and secreted proteins such as cytokines.

Streptavidin Gold Plates are designed to be the gold standard for assay performance, consistency, and convenience in immunogenicity testing, pharmacokinetic/pharmacodynamic studies, and assay development.