Author: Geurink, Lars; van Tricht, Ewoud; Dudink, Justin; Pajic, Bojana; van de Griend, Cari E. Sänger –
Title: Fourâ€step approach to efficiently develop capillary gel electrophoresis methods for viral vaccine protein analysis Cord-id: vii0s7hc Document date: 2020_7_8
ID: vii0s7hc
Snippet: Vaccines against infectious diseases are urgently needed. Therefore, modern analytical method development should be as efficient as possible to speed up vaccine development. The objectives of the study were to identify critical method parameters (CMPs) and to establish a set of steps to efficiently develop and validate a CEâ€SDS method for vaccine protein analysis based on a commercially available gel buffer. The CMPs were obtained from reviewing the literature and testing the effects of gel bu
Document: Vaccines against infectious diseases are urgently needed. Therefore, modern analytical method development should be as efficient as possible to speed up vaccine development. The objectives of the study were to identify critical method parameters (CMPs) and to establish a set of steps to efficiently develop and validate a CEâ€SDS method for vaccine protein analysis based on a commercially available gel buffer. The CMPs were obtained from reviewing the literature and testing the effects of gel buffer dilution. A fourâ€step approach, including two multivariate DoE (design of experiments) steps, was proposed, based on CMPs and was verified by CEâ€SDS method development for: (i) the determination of influenza group 1 miniâ€haemagglutinin glycoprotein; and (ii) the determination of polio virus particle proteins from an inactivated polio vaccine (IPV). The CMPs for sample preparation were incubation temperature(s) and time(s), pH, and reagent(s) concentration(s) and the detection wavelength. The effects of gel buffer dilution revealed the CMPs for CEâ€SDS separation to be the effective length, the gel buffer concentration, and the capillary temperature. The fourâ€step approach based on the CMPs was efficient for the development of the two CE methods. A fourâ€step approach to efficiently develop capillary gel electrophoresis methods for viral vaccine protein analysis was successfully established. This article is protected by copyright. All rights reserved
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