Four‐step approach to efficiently develop capillary gel electrophoresis methods for viral vaccine protein analysis

Electrophoresis, vol. 42, pp. 10–18

Abstract

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 CE-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 four-step approach, including two multivariate DoE (design of experiments) steps, was proposed, based on CMPs and was verified by CE-SDS method development for: (i) the determination of influenza group 1 mini-hemagglutinin 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 CE-SDS separation to be the effective length, the gel buffer concentration, and the capillary temperature. The four-step approach based on the CMPs was efficient for the development of the two CE methods. A four-step approach to efficiently develop capillary gel electrophoresis methods for viral vaccine protein analysis was successfully established.

Authors 5

1. Lars Geurink corresponding Aachen Janssen Vaccines & Prevention B.V

   Uppsala University · Janssen (Netherlands)

   Affiliation as printed

   Faculty of Pharmacy Department of Medicinal Chemistry Biomedical Centre Uppsala University Uppsala Sweden

   Janssen Vaccines and Prevention B.V. Leiden The Netherlands

   Faculty of Pharmacy, Department of Medicinal Chemistry, Biomedical Centre, Uppsala University, Uppsala, Sweden

   Janssen Vaccines and Prevention B.V., Leiden, The Netherlands

2. Ewoud van Tricht Aachen Janssen Vaccines & Prevention B.V

   Janssen (Netherlands)

   Affiliation as printed

   Janssen Vaccines and Prevention B.V. Leiden The Netherlands

   Janssen Vaccines and Prevention B.V., Leiden, The Netherlands

3. Justin Dudink Aachen Janssen Vaccines & Prevention B.V

   Janssen (Netherlands)

   Affiliation as printed

   Janssen Vaccines and Prevention B.V. Leiden The Netherlands

   Janssen Vaccines and Prevention B.V., Leiden, The Netherlands

4. Bojana Pajic Aachen Janssen Vaccines & Prevention B.V

   Janssen (Netherlands)

   Affiliation as printed

   Janssen Vaccines and Prevention B.V. Leiden The Netherlands

   Janssen Vaccines and Prevention B.V., Leiden, The Netherlands

5. Cari Sänger van de Griend

   Uppsala University

   Affiliation as printed

   Faculty of Pharmacy Department of Medicinal Chemistry Biomedical Centre Uppsala University Uppsala Sweden

   Kantisto BV Baarn The Netherlands

   Faculty of Pharmacy, Department of Medicinal Chemistry, Biomedical Centre, Uppsala University, Uppsala, Sweden

   Kantisto BV, Baarn, The Netherlands