About this event:

Date: December 13, 2022

Time: 11 am ET | 8 am PT |
5 pm CET

Duration: 15 minutes

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.