Contamination detection assays can be used in a broad range of applications to measure contamination in a variety of sample content from fermentation supernatants and purification processes to biochemical preparations such as serum and other bodily fluids. Contamination detection assays also measure the presence of host cell DNA as well as other DNA that might have been introduced during the biopharmaceutical manufacturing process.
Molecular Devices offers two contaminant detection assay kits under its Threshold® brand. The Threshold Immunoligand Assay (ILA) measures a broad range of analytes such as proteins, peptides, and microorganisms for biopharmaceutical development and production. The Threshold Total DNA Assay quantitatively measures picograms of single-stranded DNA. Unlike hybridization techniques that require DNA probes or primers with a specific nucleic acid sequence, Threshold Total DNA Assay measures DNA with broad sequence specificity. Established for over 10 years, Threshold Total DNA Assay is used by pharmaceutical and biotechnology companies worldwide and is recognized by the Food and Drug Administration for DNA contaminant testing.