This webcast features: Tania Chakrabarty, PhD, Senior Manager, Innovation Leader, Research and Development, Pharma Analytics, Thermo Fisher Scientific

Plasmids are common raw materials in the manufacturing of various biotherapeutics, from use as template for mRNA vaccines to gene introduction via transfection of mammalian cells for viral vector production. Worldwide regulatory agencies (WHO, EMA, US FDA, etc.) require that clearance of residual plasmid process-related impurities via downstream purification be demonstrated to below the accepted limit in the final drug substance. Previous common methods have the development of custom in-house quantitative polymerase chain reaction (qPCR) assays, involving lengthy development timelines and sourcing and maintaining various critical reagents and qualification of standards.

In this presentation, we share the development and validation of an off-the-shelf assay to accurately and reliably quantify residuals of a vast majority of the plasmids used in bioproduction that have a kanamycin resistant gene and are designed to meet regulatory requirements.

Key takeaways include:

• Regulatory guidance on residual plasmid DNA testing
• Design of a multiplex real-time PCR assay for the detection of many residual plasmids by targeting multiple antibiotic resistance gene families
• Internal validation study design and results to show sensitivity, accuracy, and robustness specification designed to meet regulatory expectations

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