resDNASEQ™ Quantitative HEK293 DNA Kits

The resDNASEQ Quantitative HEK293 DNA Kit is a quantitative PCR (qPCR)-based system for the detection of host-cell DNA from HEK293 cell lines used in the development of gene therapy, cell-based vaccines, and similar biotherapeutics. Reliable and rapid, the resDNASEQ system enables sensitive and specific* quantitation of HEK293 cell DNA. This performance helps ensure a high degree of confidence in quantitation data obtained from a broad range of sample types, from in-process samples with different sample matrices to purified final product.

This kit is specifically designed for the Chinese market and manufactured at our Guangzhou site to enable local biopharmaceutical and biotech companies to leverage a highly sensitive, world-class residual DNA quantitation solution.

This kit is available with or without sample preparation reagents in the form of a PrepSEQ Residual DNA Sample Preparation Kit, which is optimized for highly efficient residual DNA recovery from complex mixtures of proteins, buffers, and salts.

Features of the resDNASEQ Quantitative HEK293 DNA Kit include:

• Highly sensitive quantitation using proven TaqMan real-time qPCR technology
• Consistent performance across the expected range of DNA fragment sizes
• Includes master mix, TaqMan primer/probe mix, and HEK293 genomic DNA standard

Integrated workflow solution

The resDNASEQ Quantitative HEK293 DNA Kit is part of an integrated workflow for impurity and contaminant testing during biopharmaceutical manufacturing. The kit is compatible with the PrepSEQ Residual DNA Sample Preparation Kit, which offers both a manual and automated sample preparation workflow. The resDNASEQ kit has been validated on the Applied Biosystems 7500 Fast Real-Time PCR System and the QuantStudio 5 Real-Time PCR System. Data analysis is streamlined using AccuSEQ Real-Time PCR Detection Software that provides accurate quantitation and security, audit, and e-signature capabilities to help enable 21 CFR Pt 11 compliance.

Easy to use

With the resDNASEQ Quantitative HEK293 DNA Kit, qPCR analysis is performed to compare the amount of HEK293 DNA in the test samples to a standard curve generated using known amounts of purified HEK293 DNA standard. The resDNASEQ kit includes almost everything needed to carry out these steps, from master mix to TaqMan primer/probe mix to HEK293 genomic DNA standard, as well as step-by-step instructions.

Consistent performance

For accurate quantitation of residual HEK293 DNA, assay results must be unaffected by the size of the DNA molecules present in the test sample. With the resDNASEQ system you get consistent assay performance across a range of DNA fragment sizes.

*Due to the high degree of similarity between genomes, DNA from closely-related primate species, such as monkey (Vero), chimpanzee, and orangutan, are expected be detected by the resDNASEQ HEK293 Quantitation Kit.