Corning Videodrop Method for Lentiviral Vector Quality Control

This technical report outlines the suitability of the Corning Videodrop as a quality control method for physical titer monitoring of lentiviral vectors in Good Manufacturing Practice (GMP) environments. It describes the validation process of the Corning Videodrop methodology according to the International Conference on Harmonization Q2 (ICH Q2) guidelines, focusing on parameters such as linearity, accuracy, and precision. The study evaluates samples collected during the biomanufacturing of lentiviral vector batches, detailing the analytical methods used and the results obtained. The report presents findings from over 150 measures, demonstrating the effectiveness of the Corning Videodrop in measuring lentiviral vector concentrations. It also discusses the integration of this methodology into GMP bioprocessing and its relevance for clinical trial applications. The results indicate that the Corning Videodrop can be reliably used for in-process controls in lentiviral vector production, contributing to the quality assurance of gene therapies.