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Threshold® Contamination Detection System - Shorten time from research to approval using rapid, highly sensitive, radioactive-free immunoassays

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Producing biopharmaceuticals such as monoclonal antibodies, vaccines, nucleic acids and recombinant proteins requires quality control methods and special techniques such as chromatography, electrophoresis and immunochemical methods. These techniques are commonly used to monitor and optimize the biopharmaceutical process.  The Threshold® Contamination Detection system from Molecular devices provides rapid, quantitative measurement of biopharmaceutical products or contaminates from bioreactor/fermenters, downstream processing or final product quality control and is ideal for measuring the amount of proteins, peptides and non-sequence specific total DNA.

For more information about the Threshold® system or to request a quote or a demonstration please CLICK HERE

Threshold® offers many advantages over other methods:

•    A Complete validation package and security tools including Software that complies with GLP, GMP and FDA 21 CFR Part 11 requirements

•    Excellent sensitivity due to liquid phase binding reaction and proprietary silicon sensor technology (LAPS): DNA in the low picogram range (Total DNA-Assay), proteins in ppm (Immuno Ligand Assay)

•    Use one assay from assay/process development to final QC

•    Quality controlled and certified reagent kits available for total DNA and host cell derived contaminant proteins (HCP)

•    Flexible assay formats allow for minimized matrix interference

•    Rapid assay development and assay transfer

•    Established and proven technology, supported by more than 20 years’ experience

The Threshold® Contamination Detection system has a long, established track record of use in successful Investigational New Drug applications (IND), Product Licence Applications (PLA) and with wide acceptance by regulatory bodies such as the FDA it has become the gold standard in contaminant detection throughout the drug discovery pipeline.

To download the Threshold® data sheet CLICK HERE

Threshold® measures picograms including: host cell proteins and total DNA

The Threshold® system measures picograms such as host cell proteins and total DNA using an enzyme-linked immunoassay. Assay sensitivity for proteins and peptides is typically equal to or better than radioimmunoassay’s and at least 10X better than ELISA assays. When measuring DNA, sensitivity as low as 2 picogram (pg) can be achieved. Typically assays have a dynamic range of 2 logs or greater, so fewer sample dilutions are required for accurate quantitation. Assays are fast and are complete in as little as 90 seconds.

The Threshold® Software controls the instrument and collects and analyses the data. To simplify assay development, the following reagent kits are available to label your antibodies or commercially available antibodies.

Total DNA Assay Kit

The Total DNA Assay is used by pharmaceutical and biotechnology companies worldwide and quantitatively measures picograms of single-stranded DNA. Unlike hybridization techniques which require DNA probes or primers with a specific nucleic acid sequence, Total DNA assay measures DNA with broad sequence specificity. This enables the Threshold® system to measure host cell DNA as well as other DNA that could have been introduced during the biopharmaceutical process. As the assay does not require sequence specific probes or primers, the Threshold® Total DNA Assay can easily be applied to different samples purified from different host organisms.

To find out more about this assay kit CLICK HERE

Immuno-Ligand Assay Kit

The Threshold® Immuno-Ligand Assay (ILA) measures a broad range of analytes such as, drugs, proteins, and micro-organisms for biopharmaceutical development and production. Samples can range from fermentation supernatants, samples from a purification process and other biochemical preparations, to serum or other bodily fluids.

To find out more about this assay kit CLICK HERE

To download application notes and see a list of publications CLICK HERE

Product Threshold® Contamination Detection System - Shorten time from research to approval using rapid, highly sensitive, radioactive-free immunoassays
Company Molecular Devices
Price Request a quote
More Information View company product page
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Molecular Devices
660 - 665 Eskdale Road Winnersh Triangle Wokingham Berkshire RG41 5TS

Tel: +44-118-944-8000
Fax: +44-118-944-8001

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