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

AI Article Synopsis

  • - V937 is an experimental cancer treatment using a modified Coxsackievirus A21 (CVA21) that targets and destroys tumor cells with high levels of ICAM-1 receptors and is currently undergoing phase I and II clinical trials.
  • - The V937 virus is made up of a 30 nm capsid containing viral RNA, and effective methods to analyze and quantify these virus particles are crucial for its development and regulatory approval.
  • - A new size-exclusion chromatography (SEC) technique utilizing multiple detection methods has been developed to evaluate virus particle quantity, size, and purity, as well as to study how V937 degrades under stress conditions, potentially leading to genome release and particle clumping.

Article Abstract

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

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8718657PMC
http://dx.doi.org/10.1016/j.omto.2021.12.009DOI Listing

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