Development and validation of quantitative real-time PCR for the detection of residual HEK-293 host cell DNAPublished: March 16, 2020
The presence of residual DNA carried by gene therapy products in the body may lead to an increased risk of oncogenicity, immunogenicity, and other toxicity. Current regulatory authorities (WHO, EMA and US FDA) limited the accepted amounts of residual DNA in biological products making it extremely important to have a sensitive method of quantifying residual host cell DNA. Among the methods of detecting residual DNA, qPCR is the most widely used for residual DNA quantitation due to its sensitivity, accuracy, precision, and time-saving capability. In this webinar, we share the development and validation of a new, highly sensitive and accurate integrated solution for detection and quantitation of low level HEK-293 DNA to help meet regulatory requirements.
Webinar participants learn:
- Overview of current regulatory requirements for residual host DNA clearance for biological products and what that means for gene therapy applications.
- A streamlined, automated workflow for quick quantification of residual HEK-293 host cell DNA
- Performance specifications for the new Applied Biosystems resDNASEQ Quantitative HEK-293 DNA system.
Dr. Kara Norman, Senior Manager, Research & Development, Pharmaceutical Analytics, Thermo Fisher Scientific
With a lifelong passion for improving health care through cutting-edge research, new technologies, and cross-disciplinary teamwork, Dr. Kara Norman has played key roles in developing myriad new quality assurance products for oncology research. She currently leads the Pharma Analytics R&D team at Thermo Fisher Scientific, overseeing the development of reagents and software to help ensure the quality and safety of biopharmaceutical products via DNA sequencing and real-time PCR. Previously, Dr. Norman led an R&D organization developing quality controls and standards for clinical lab testing. She was a key member of the team that launched the first IVD products for next-generation sequencing (NGS) for oncology, and also helped develop custom controls for IVD manufacturers and QC monitoring software for clinical labs. Dr. Norman received her PhD from the Universityof Calgary, Canada, where she studied molecular oncology and virology. There, she helped pioneer development of Reolysin, a novel, virus-based anti-cancer therapy that is now in late-stage clinical testing. She subsequently did postdoctoral research at Stanford University, where she led studies in NGS of miRNA and determined key molecular off-target effects of the antisense miR-122 oligonucleotide, a promising anti-hepatitis C virus (anti-HCV) therapy.