Robust quantitation of residual host cell and plasmid DNA & oncogenic fragments in HEK-based viral vector manufacturing

Cell & Gene Therapy Insights 2022; 8(8), 1245;

DOI: 10.18609/cgti.2022.182

Published: 16 October 2022
FastFacts


Watch the video or read the poster to learn more about:

  • Current regulatory guidance on residual DNA test requirements and how this relates to typical viral vector process
  •  Data on residual DNA and fragment sizing assays suitable for validation per industry expectations to support process development and lot-release QC
  • Clearance data from a typical AAV downstream process 
  • Design concept and specification for a novel rapid method for quantitation of various E1A fragment sizes

Jonas is a Product Manager with the Pharma Analytics group at Thermo Fisher Scientific, supporting customers with validated Pharma Analytics solutions for biomanufacturing processes across various therapeutic modalities. His focus is on identifying and delivering new assays, especially in the field of ATMPs, to improve current analytical testing solutions and close gaps of current and future testing needs. Jonas has an MSc in Industrial Engineering from Leibniz University, Hannover, Germany