Controlling residual host cell DNA in viral vaccine manufacturing: optimizing endonuclease treatment in viral vector and vaccine processes

Tuesday 08:00 PST / 11:00 EST / 16:00 GMT / 17:00 CET

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Controlling residual host cell DNA in viral vaccine manufacturing: optimizing endonuclease treatment in viral vector and vaccine processes

Live30 webinars pack the latest innovations and applications into a data-rich 30-minute session.

Is your endonuclease step delivering >99% host cell DNA (hcDNA) reduction, yet your final drug substance still misses specification? This webinar explains why digestion efficiency alone does not determine residual DNA levels, and how upstream titer and downstream concentration factor govern the outcome.

Drawing on a DOE study and an integrated downstream evaluation in a Vero cell-based process, the speakers will identify the process parameters that drive DNA reduction, incubation time, enzyme concentration, and temperature, and quantify their relative impact. The session will also present fragment size distribution data showing the shift toward sub-200 bp species relevant to US FDA expectations on residual DNA size, alongside infectious titer data confirming product stability under treatment conditions.

While the data presented are drawn from a viral vaccine process, the same hcDNA control challenges apply to viral vector manufacturing, including AAV and lentiviral vectors, where limited chromatographic clearance places a greater burden on clarification, endonuclease treatment, and tangential flow filtration (TFF). Attendees will take away baseline digestion conditions, a framework for positioning endonuclease treatment either before or after harvest clarification, and an operational logic for balancing upstream productivity targets against downstream purification requirements.

Attend this webinar to:

Apply baseline digestion parameters derived from a full factorial study across 135 reactions per enzyme, that balance DNA cleavage against virus stability.
Evaluate fragment size distribution data showing a shift from kilobase-range DNA to a predominant signal below 200 bp, consistent with US FDA guidance on residual DNA size.
Position endonuclease treatment before or after clarification using integrated process data showing no consistent difference in overall performance or infectious virus recovery.
Model how upstream titer and tangential flow filtration (TFF) concentration factor determine final hcDNA burden, and why reduction exceeding 99% during digestion does not guarantee specification compliance.

Dieter Palmberger

CTO & Co-Founder at bespark*bio

Dieter Palmberger is CTO at bespark*bio, where he leads scientific and technical activities in bioprocess development. He has extensive experience in the development and optimization of bioprocesses for complex biological products, with a particular focus on viral vectors and advanced bioprocessing technologies. His work spans upstream and downstream process development, with an emphasis on developing robust and scalable manufacturing processes.

Matthias Müllner

CEO & Co-Founder at bespark*bio

Matthias is a bioprocessing leader driven by one central question: why do so many breakthrough therapies fail not because of science, but because of manufacturing? Trained in virology and molecular biology, he spent over 15 years in biotech translating innovation into clinical reality. At Themis Bioscience, he built and led Technical Operations and helped bring vaccine programs from early research into clinical development.

After witnessing repeated CMC bottlenecks slow down promising therapies, he co-founded bespark*bio to rethink how bioprocessing is approached. His work focuses on combining deep industrial know-how with data modeling and digital tools to drastically reduce experimental burden and make development more predictive.His mission: to transform bioprocessing from trial-and-error into a data-driven discipline. So life-changing therapies reach patients faster and more reliably.

In 47 Days

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