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 language | English |
|---|---|
| Pages (from-to) | 1-8 |
| Number of pages | 8 |
| Journal | Electrophoresis |
| DOIs | |
| Publication status | E-pub ahead of print - 5 Apr 2019 |
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Bibliographical note
This article is protected by copyright. All rights reserved.Keywords
- Analytical quality by design
- At-line IPC testing
- Capillary zone electrophoresis lifecycle management
- Virus quantification
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Implementation of at-line capillary zone electrophoresis for fast and reliable determination of adenovirus concentrations in vaccine manufacturing. / van Tricht, Ewoud; Geurink, Lars; Galindo Garre, Francisca; Schenning, Martijn; Backus, Harold; Germano, Marta; Somsen, Govert W.; Sänger – van de Griend, Cari E.
In: Electrophoresis, 05.04.2019, p. 1-8.Research output: Contribution to Journal › Article › Academic › peer-review
TY - JOUR
T1 - Implementation of at-line capillary zone electrophoresis for fast and reliable determination of adenovirus concentrations in vaccine manufacturing
AU - van Tricht, Ewoud
AU - Geurink, Lars
AU - Galindo Garre, Francisca
AU - Schenning, Martijn
AU - Backus, Harold
AU - Germano, Marta
AU - Somsen, Govert W.
AU - Sänger – van de Griend, Cari E.
N1 - This article is protected by copyright. All rights reserved.
PY - 2019/4/5
Y1 - 2019/4/5
N2 - 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.
AB - 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.
KW - Analytical quality by design
KW - At-line IPC testing
KW - Capillary zone electrophoresis lifecycle management
KW - Virus quantification
UR - http://www.scopus.com/inward/record.url?scp=85064480198&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85064480198&partnerID=8YFLogxK
U2 - 10.1002/elps.201900068
DO - 10.1002/elps.201900068
M3 - Article
SP - 1
EP - 8
JO - Electrophoresis
JF - Electrophoresis
SN - 0173-0835
ER -