The biopharmaceutical industry is approaching a turning point where new therapeutic modalities such as virus-based biopharmaceuticals are used in several applications such as vaccination, gene therapy and oncolytic therapy. However, the bioprocess of functional viruses still presents challenges, namely due to the availability of suitable analytics for downstream processing monitoring or characterization of the final product. Capillary electrophoresis (CE) is a versatile technique that enables the determination of intact or reduced particle number and the quantification of several product-related impurities, such as host cell DNA and host cell proteins. Although this f platform is commonly used for purity profiling of monoclonal antibodies in the pharmaceutical industry by ultraviolet (UV) detection, it requires a large amount of product, making it not suitable for virus-based pharmaceuticals, where total protein concentration (dose) is relatively low.
This work presents a highly sensitive CE methodology for monitoring different bioprocess steps and final product characterization of several viral vectors. A fluorescence labelling procedure using the (3-(2-furoyl) quinoline-2-carboxaldehyde dye was used, enabling the detection of the viral proteins through Sodium dodecyl sulfate-capillary gel electrophoresis (CE-SDS) method coupled to a laser-induced fluorescence (LIF) detector.
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