| 1. |
- van Tricht, Ewoud, et al.
(author)
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Implementation of at-line capillary zone electrophoresis for fast and reliable determination of adenovirus concentrations in vaccine manufacturing
- 2019
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In: Electrophoresis. - : Wiley. - 0173-0835 .- 1522-2683. ; 40:18-19, s. 2277-2284
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Journal article (peer-reviewed)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.
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| 2. |
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| 3. |
- El Deeb, Sami, et al.
(author)
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Recent advances in capillary electrophoretic migration techniques for pharmaceutical analysis
- 2014
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In: Electrophoresis. - : Wiley. - 0173-0835 .- 1522-2683. ; 35:1, s. 170-189
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Research review (peer-reviewed)abstract
- Since the introduction about 30 years ago, CE techniques have gained a significant impact in pharmaceutical analysis. The present review covers recent advances and applications of CE for the analysis of pharmaceuticals. Both small molecules and biomolecules such as proteins are considered. The applications range from the determination of drug-related substances to the analysis of counterions and the determination of physicochemical parameters. Furthermore, general considerations of CE methods in pharmaceutical analysis are described.
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| 4. |
- El Deeb, Sami, et al.
(author)
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Recent advances in capillary electrophoretic migration techniques for pharmaceutical analysis (2013-2015)
- 2016
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In: Electrophoresis. - : Wiley. - 0173-0835 .- 1522-2683. ; 37:12, s. 1591-1608
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Research review (peer-reviewed)abstract
- This review updates and follows-up a previous review by highlighting recent advancements regarding capillary electromigration methodologies and applications in pharmaceutical analysis. General approaches such as quality by design as well as sample injection methods and detection sensitivity are discussed. The separation and analysis of drug-related substances, chiral CE, and chiral CE-MS in addition to the determination of physicochemical constants are addressed. The advantages of applying affinity capillary electrophoresis in studying receptor-ligand interactions are highlighted. Finally, current aspects related to the analysis of biopharmaceuticals are reviewed. The present review covers the literature between January 2013 and December 2015.
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| 5. |
- Sänger-van de Griend, Cari E, Dr, et al.
(author)
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Capillary Electrophoresis : an Attractive Technique for Chiral Separations
- 2013
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In: Chromatography Today. - 1752-8070. ; 6:2, s. 32-37
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Research review (peer-reviewed)abstract
- Capillary Electrophoresis (CE) separates compounds that differ in charge to hydrodynamic size ratio and is an excellent technique for the analysis of polar compounds. The technique is particularly applicable to chiral separations. Chiral CE separation is achieved by adding a chiral selector to the so called background electrolyte. The enantiomers then form fast, reversible equilibria with the selector. In this paper a simple method development strategy for basic, acidic and neutral compounds is presented and illustrated with examples and common pitfalls. Some important good working practices (background electrolyte buffer recipes, temperature, corrected peak area, injection, polyimide coating removal from capillary ends) are highlighted, so that a good chiral separation can be developed into a robust analytical method.
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