SEC coupled with in-line multiple detectors for the characterization of an oncolytic Coxsackievirus

• DOI: 10.1016/j.omto.2021.12.009
• Publication Date: 2021-12-11T07:16:23Z
• Authors: James Z. Deng; Richard R. Rustandi; Andrew Swartz; Yvonne Shieh; Jack B. Baker; Josef Vlasak; Shiyi Wang; John W. Loughney
• Keywords: Coxsackievirus

V937 is an oncolytic virus immunotherapy clinical drug candidate consisting of a proprietary formulation Coxsackievirus A21 (CVA21). specifically binds to and lyses cells with over-expressed ICAM-1 receptors in range tumor cell types currently phase I II trials. Infectious particles consist ∼30 nm icosahedral capsid assembled from four structural viral proteins that encapsidate RNA genome. Rapid robust analytical methods quantify characterize CVA21 are important support the process development, regulatory requirements, validation new manufacturing platforms. Herein, we describe size-exclusion chromatography (SEC) method was developed substance intermediates. Using 4-in-1 combination multi-detectors (UV, refractive index, dynamic static light scattering), demonstrate use SEC for quantification particle count, determination size (molecular weight hydrodynamic diameter), characterization purity by assessing empty-to-full ratios. Through analysis stressed samples, propose thermal degradation pathways result genome release aggregation.