HEK293 Residual Host Cell Quantitation Made Easy in Bioprocessing Workflows:

A Robust, Highly Sensitive Real-Time PCR assay

May 18th, 2021 • 8 a.m. PT, 11 a.m. ET

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Overview

The HEK293 cell line is one of the most widely used in the production and manufacturing of various biologics, from recombinant proteins to viral vectors. It is critical that residual host cell DNA is minimized in the final drug substance to ensure product quality and patient safety.

Regulatory authorities around the world including the WHO, EMA and the US FDA, therefore, limit the amount of residual host cell DNA allowed in the final drug product.

A highly sensitive, rapid method to quantify residual host cell DNA is important to ensure clearance by the purification process and for lot-release testing. Yet developing a home-brew assay can be resource intensive and risky as they usually rely on various component vendors.

In this webinar we will share the design, performance, and workflow implementation of a highly sensitive, robust, off-the-shelf solution to specifically quantitate the residual host cell DNA from HEK293 cells designed to meet regulatory requirements.

In this webinar you’ll learn:

  • An overview of current regulatory requirements for residual host cell DNA clearance for biological products
  • A streamlined, automated workflow for rapid, accurate and sensitive quantification of residual HEK293 host cell DNA 
  • Detailed performance specifications for the Applied Biosystems resDNASEQ Quantitative HEK293 DNA system

Who should attend:

  • Process Development Scientists
  • Analytical Development Scientists
  • Quality Control, Quality Assurance Scientists
  • Regulatory/CMC Managers 

Presenters

Presenter
Florian Durst
(Presenter)
Sr. Field Application Scientist
Thermo Fisher Scientific
View Biography
Presenter
Mike Auerbach
(Moderator)
Editor-in-Chief,
American Pharmaceutical Review