DNA Clearance and Lot Release Testing Services

Nucleic Acids such as DNA in biotherapeutics are a cellular contaminant that must be removed from the final product.  The acceptable residual amount of DNA is between 0.1ng – 10ng per dose, depending on the regulatory authorities.  MicroBioTest offers validated quantitative polymerase chain reaction (qPCR)-based assays for DNA Clearance evaluation for bio-processing steps and for lot release DNA analyses for murine cells and other cell types.