Implementation of at-line capillary zone electrophoresis for fast and reliable determination of adenovirus concentrations in vaccine manufacturing

Ewoud van Tricht*, Lars Geurink, Francisca Galindo Garre, Martijn Schenning, Harold Backus, Marta Germano, Govert W. Somsen, Cari E. Sänger – van de Griend

*Corresponding author for this work

Research output: Contribution to JournalArticleAcademicpeer-review

34 Downloads (Pure)

Abstract

A CZE method was validated and implemented for fast and accurate in-process determination of adenovirus concentrations of downstream process samples obtained during manufacturing of adenovirus vector-based vaccines. An analytical-quality-by-design approach was embraced for method development, method implementation, and method maintenance. CZE provided separation of adenovirus particles from sample matrix components, such as cell debris, residual DNA and proteins. The intermediate precision of the virus particle concentration was 6.9% RSD and the relative bias was 2.3%. In comparison, the CZE method is intended to replace a quantitative polymerase chain reaction method which requires three replicates in three analytical runs to achieve an intermediate precision of 8.1% RSD. Given that, in addition, the time from sampling till reporting results of the CZE method was less than 2 h, whereas quantitative polymerase chain reaction requires 3 days, it follows that the CZE method enables faster processing times in downstream processing.

Original languageEnglish
Pages (from-to)2277-2284
Number of pages8
JournalElectrophoresis
Volume40
Issue number18-19
Early online date5 Apr 2019
DOIs
Publication statusPublished - Sep 2019

Bibliographical note

Special Issue: Celebrating Professor Ziad El Rassi's 70th Birthday and His 25 Years of Dedication to Electrophoresis.

Keywords

  • Analytical quality by design
  • At-line IPC testing
  • Capillary zone electrophoresis lifecycle management
  • Virus quantification

Fingerprint Dive into the research topics of 'Implementation of at-line capillary zone electrophoresis for fast and reliable determination of adenovirus concentrations in vaccine manufacturing'. Together they form a unique fingerprint.

Cite this