resDNASEQ™ dPCR E. coli DNA Kit (Applied Biosystems™)

The Applied Biosystems resDNASEQ dPCR E. coli DNA Kit is a digital PCR (dPCR)-based solution to detect host-cell DNA from E. coli, an expression system commonly used for production of recombinant proteins and plasmids. Reliable and rapid, the assay enables sensitive and specific quantification of E. coli DNA, helping provide confidence in quantitation data obtained from a broad range of sample types, from in-process samples with different sample matrices to formulations with final products.

Features of the resDNASEQ dPCR E.coli DNA Kit include:
• Accurate, absolute quantitation of residual host-cell E. coli DNA
• Highly sensitive quantitation using proven TaqMan Assays, with results in under three hours
• Highly characterized E. coli DNA control that can be leveraged during qualification and verification
• Easy-to-use, integrated sample-to-results kit consisting of Absolute Q DNA Digital PCR Master Mix, E. coli assay mix, well-characterized DNA positive control, and DNA dilution buffer
• Manual or automated sample preparation, optimized for quantitative recovery of samples from complex matrices

Integrated workflow solution
The resDNASEQ dPCR E. coli DNA Kit is part of an integrated workflow for impurity and contaminant testing during biopharmaceutical manufacturing. The kit has been validated on the QuantStudio Absolute Q Digital PCR System. The Absolute Q system has a high tolerance of common inhibitors in biopharmaceutical sample matrices, eliminating the need for nucleic acid extraction in some cases. If nucleic acid extraction is required, we recommend use of the PrepSEQ Residual DNA Sample Preparation Kit, which offers both a manual and automated sample preparation workflow.

Easy to use
With the resDNASEQ dPCR E. coli DNA Kit, dPCR analysis is performed to quantitate the copy numbers of residual E.coli DNA in the test samples. The resDNASEQ kit includes almost everything needed to carry out these steps, from master mix to TaqMan primer/probe mix to E. coli genomic DNA control, as well as step-by-step instructions. A copy-to-mass conversion tool is also provided to guide you on the final result conversion to satisfy regulation requirements.