The Threshold System

The Threshold® system reduces the time required to develop, validate and perform ultra-sensitive assays with maximum speed, sensitivity, reproducibility and reliability. The complete system includes the Threshold instrument, reagents and software.

The Threshold system is used by a majority of pharmaceutical and biotech companies worldwide to detect and quantitate, at picogram levels, contaminants in their biopharmaceutical products. Contaminants commonly analyzed with the Threshold system include total DNA, host cell proteins, bovine contaminants (e.g., BSA, IgG, insulin, transferrin), Proteins A and G, and any unique protein that can be bound by antibodies. Other applications include measurement of sequence-specific DNA and plasmid copy number.

The Threshold system is routinely used in assay development, process development and quality control applications, often in highly regulated environments. The military uses Threshold also for the detection of bio-warfare agents.

The system's proven advantages of sensitivity, speed, reproducibility and reliability, as well as MDC's strong technical experience and support, have elevated this system to a gold standard level in the industry.

Recently, with the introduction of the Threshold Enterprise 1.0 Software, MDC has furthered its commitment to its Threshold business and customers by providing electronic security tools for those labs required to comply with FDA 21 CFR Part 11.