dPCR strategies for sensitive quantification and fragment size assessment of residual host cell DNA

Tuesday 09:00 PDT / 12:00 EDT / 16:00 GMT / 17:00 CET

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dPCR strategies for sensitive quantification and fragment size assessment of residual host cell DNA

Residual host cell DNA (resDNA) is a critical quality attribute in cell and gene therapy manufacturing, with regulatory expectations spanning both highly sensitive quantification and robust assessment of DNA fragment size. This webinar outlines a digital PCR (dPCR)-based workflow that integrates absolute quantification of residual human or HEK-293 DNA with fragment size estimation in a single analytical approach.

By targeting a stable multicopy genomic locus using short and long amplicons, the method supports low limits of detection and quantification, high precision, and accurate measurement across a wide dynamic range. The speakers will also present data demonstrating robust fragment size determination for both fragmented and non-fragmented DNA.

The session will further explore optional multiplexing with oncogene targets, including E1A, E1B, and SV40, to support risk-based impurity testing strategies when required. By attending, you will gain practical considerations for deploying extraction-free, high-throughput workflows in regulated environments to simplify resDNA testing while maintaining analytical rigor from early development through manufacturing.

Attend this webinar to:

Explore data demonstrating robust fragment size determination across fragmented and non-fragmented DNA within a single assay
Understand how an integrated dPCR workflow supports low limits of detection and quantification, high precision, and broad dynamic range for resDNA testing
Learn how multiplexing with oncogene tragets maintain quantification accuracy and size assessment to enable risk-based impurity characterization
Apply practical strategies to simplify resDNA testing workflows while supporting process characterization, routine monitoring, and scale-up to commercial manufacturing

Jana Kul

Senior Scientist, VTC at Boehringer Ingelheim

Senior Scientist in analytical development at virus therapeutic center (BI), responsible method development and implementation of nucleic acid amplification technology (NAT)-based methods. QC-Manager at Labor Dr. Merk & Kollegen, responsible for analytical method validation/qualification of NAT-based methods such as qPCR, PCR, and virus sequence analyses. Before joining the industry, Jana completed a postdoctoral fellowship in cancer vaccine research and earned her PhD in immunology and vaccine development.

Anida Mesihovic Karamitsos

Global Product Manager at QIAGEN

Global Product Manager for digital PCR biopharma applications at QIAGEN, where she works on strategies for dPCR-based analytical solutions supporting advanced therapeutics. Product management experience in molecular and immunology based IVD solutions for infectious disease. Before transitioning into industry, she completed a postdoctoral fellowship in cancer epigenetics and earned her PhD in plant molecular biology.

Miroslav Vranes

Associate Director, R&D at QIAGEN

Miroslav Vranes studied biology at Philipps University in Marburg and completed his doctoral research at the Max Planck Institute for Terrestrial Microbiology. He continued his scientific work during a postdoctoral appointment at the Karlsruhe Institute of Technology before joining QIAGEN in 2015. Since then, he has contributed to the development of multiple PCR and digital PCR products and applications, with a strong focus on advancing dPCR solutions for Pharma and Biopharma workflows.

In 32 Days

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