Today's key tools and innovation requirements to meet future demands

Current regulatory authorities limit the accepted amounts of residual DNA in biological products, making it extremely important to have a sensitive method of quantifying residual host cell DNA. Quantitative polymerase chain reaction (qPCR) is the most widely used for residual DNA quantitation due to its sensitivity, accuracy, precision, and time‑saving capability.

WF24615-whitepaper

This article examines the development and validation of a new, highly sensitive and accurate integrated solution for the detection and quantitation of low level HEK‑293 DNA to help meet regulatory requirements.

In this whitepaper, you will learn about:

  • Important considerations when choosing between manual and automated sample preparation methods
  • Features that help enable 21 CFR Part ll compliance
  • Accuracy, precision, Limit of Detection (LOD), and Limit of Quantitation (LOQ)
  • Sample prep performance from a variety of matrices common to gene therapy bioproduction workflows

To download our free whitepaper, Development and validation of quantitative real‑time PCR for the detection of residual HEK‑293 host cell DNA, please complete the short form below.