Voices of Biotech
Podcast: MilliporeSigma says education vital to creating unbreakable chain for sustainability
MilliporeSigma discusses the importance of people, education, and the benefits of embracing discomfort to bolster sustainability efforts.
- Sponsored Content
- Manufacturing
Simplify Residual DNA Quantitation in Viral Vector Production With qPCR and dPCR Tools
BPI Contributor
December 13, 2022
20 Min View
Date: Dec 13, 2022
Duration: 20 Min
Sponsored by Thermo Fisher Scientific
This webcast features: Jonas Buege, Senior Product Manager, Pharma Analytics, Thermo Fisher Scientific.
Amongst the challenges for clinical grade viral vector production is the removal of residual DNA impurities from the final drug product. Unlike traditional biologics, undesirable copackaging of residual host cell DNA as well as plasmid DNA in the viral vector capsid can lead to elevated quantities. Regulatory scrutiny has increased due to safey concerns of not only larger amounts, but also potential for inclusion of longer residual fragments and specific sequences of oncogenic potential. Thus, the needs of analytical tools to rapidly and reliably measure these attributes in process development as well as quality control manufacturing are critical.
In this webinar, we will briefly discuss the regulatory guidance around residual DNA testing, how this applies to viral vector production, and present an easy to implement analytical solution designed to meet regulatory guidance to measure the various different sources and aspects of this process related impurity. We will share data obtained from a qPCR-based method from a typical AAV process using the HEK293 triple transfection production system, and will introduce development data for assays on digital PCR.
Key Takeaways:
Overview of regulatory guidance on residual DNA quantitation and fragment sizing.
Performance data for a comprehensive solution for quantitation and fragment sizing of residual host cell, plasmid, and a common oncogene in viral vector production in HEK293 cells.
Introduction to digital PCR solution for residual DNA quantitation.
Just fill out the form below to view the recorded webcast now.
About the Author(s)
You May Also Like
Upcoming Webcasts
Jun 17 - Jun 20, 2024
Jun 17 - Jun 20, 2024
Our Biopharmaceutical School is the perfect course to gain a well-rounded understanding of the Biopharmaceutical industry. Over three days, you will understand the principle steps in the biopharmaceutical lifecycle, including: raw material selection, up and downstream processes and core technology. Additionally, you will be familiarised with the latest industry trends, including Industry 4.0, and how these are likely to impact the industry’s evolution.
Through a combination of sessions led by experts from the likes of GSK and Pall Biotech, as well as group discussions with your peers, you will learn how to bring a biopharmaceutical drug to market. Each day will be chaired by a different member of the BioProcess International Academy faculty and there will also be time for networking and Q&As with the experts.
Learn More