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Implementation of at-line capillary zone electrophoresis for fast and reliable determination of adenovirus concentrations in vaccine manufacturing
Janssen Vaccines & Prevent, Pharmaceut & Analyt Dev, Leiden, Netherlands.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Medicinal Chemistry, Analytical Pharmaceutical Chemistry. Janssen Vaccines & Prevent, Pharmaceut & Analyt Dev, Leiden, Netherlands.
Janssen Vaccines & Prevent, Pharmaceut & Analyt Dev, Leiden, Netherlands.
Janssen Vaccines & Prevent, Pharmaceut & Analyt Dev, Leiden, Netherlands.
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2019 (English)In: Electrophoresis, ISSN 0173-0835, E-ISSN 1522-2683, Vol. 40, no 18-19, p. 2277-2284Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
2019. Vol. 40, no 18-19, p. 2277-2284
Keywords [en]
Analytical quality by design, At-line IPC testing, Capillary zone electrophoresis lifecycle management, Virus quantification
National Category
Analytical Chemistry Pharmaceutical Sciences
Identifiers
URN: urn:nbn:se:uu:diva-392980DOI: 10.1002/elps.201900068ISI: 000483858400006PubMedID: 30951206OAI: oai:DiVA.org:uu-392980DiVA, id: diva2:1350763
Available from: 2019-09-12 Created: 2019-09-12 Last updated: 2019-10-18Bibliographically approved

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Geurink, LarsSänger – van de Griend, Cari E.

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