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Sänger - van de Griend, Cari
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Publications (7 of 7) Show all publications
Yao, H., Vandenbossche, J., Sänger - van de Griend, C., Janssens, Y., Fernandez, C. S., Xu, X., . . . De Spiegeleer, B. (2018). Development of a capillary zone electrophoresis method to quantify E. coli L-asparaginase and its acidic variants. Talanta: The International Journal of Pure and Applied Analytical Chemistry, 182, 83-91
Open this publication in new window or tab >>Development of a capillary zone electrophoresis method to quantify E. coli L-asparaginase and its acidic variants
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2018 (English)In: Talanta: The International Journal of Pure and Applied Analytical Chemistry, ISSN 0039-9140, E-ISSN 1873-3573, Vol. 182, p. 83-91Article in journal (Refereed) Published
Abstract [en]

A capillary zone electrophoresis (CZE) method with UV detection was developed for the quantification of the E.coli L-asparaginase (L-ASNase) and its acidic variants. During the initial method development, a variety of experimental conditions were screened. Subsequently, a Design of Experiments (DoE) was used to optimize the pH and concentration of the selected background electrolyte (BGE) containing both TRIS and boric acid. Optimization was performed taking into account both the separation efficiency of L-ASNase and its acidic variants as well as overall method robustness. A repeatable separation between E.coli L-ASNase and its acidic variants was achieved on a bare fused silica capillary in combination with a BGE consisting of both 400 mM TRIS and boric acid. The method was validated for linearity, accuracy, precision, LOD, LOQ and robustness. The recovery for L-ASNase was 97.9-104.4% with a precision RSD of 1.5-3.2%, while the recovery of impurities was 92.1-109.8% with a RSD of 1.7-4.6%. The quantification limit was 1.9% (m/m). Moreover, the CZE-UV method was applied to determine the degradation rate in the presence of ammonium bicarbonate, confirming the suitability of the method. The degraded, partially charged L-ASNase was evaluated for its in-vitro enzymatic activity showing an insignificant different enzyme activity compared to the unmodified sample.

Place, publisher, year, edition, pages
ELSEVIER SCIENCE BV, 2018
Keywords
l-asparaginase, Capillary zone electrophoresis, Acidic impurities, Design of experiments (DoE)
National Category
Biochemistry and Molecular Biology
Identifiers
urn:nbn:se:uu:diva-353099 (URN)10.1016/j.talanta.2018.01.048 (DOI)000428229200010 ()29501203 (PubMedID)
Available from: 2018-06-20 Created: 2018-06-20 Last updated: 2018-06-20Bibliographically approved
Paul, P., Duchateau, T., Sänger - van de Griend, C., Adams, E. & Van Schepdael, A. (2017). Capillary electrophoresis with capacitively coupled contactless conductivity detection method development and validation for the determination of azithromycin, clarithromycin, and clindamycin. Journal of Separation Science, 40(17), 3535-3544
Open this publication in new window or tab >>Capillary electrophoresis with capacitively coupled contactless conductivity detection method development and validation for the determination of azithromycin, clarithromycin, and clindamycin
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2017 (English)In: Journal of Separation Science, ISSN 1615-9306, E-ISSN 1615-9314, Vol. 40, no 17, p. 3535-3544Article in journal (Refereed) Published
Abstract [en]

A capillary electrophoresis with capacitively coupled contactless conductivity detection based method for the assay of azithromycin, clarithromycin and clindamycin was optimized and validated in this study. A buffer solution of 20 mM 2-(N-morpholino) ethane sulfonic acid, 40 mM L-histidine and 0.6 mM cetyltrimethylammonium bromide (pH 6.39) was used for the electrophoresis. An uncoated, bare-fused silica capillary (total length 60 cm, effective length 32 cm, 75 mu m id) was used at 25 degrees C. The sample was injected hydrodynamically at 0.5 psi for 5 s. The electrophoresis was conducted at 30 kV in reverse polarity for 6 min with 3 and 2 min of in-between sodium hydroxide (0.1 M) and background electrolyte rinsing, respectively. Ammonium acetate was used as internal standard. This simple and robust method showed reasonable limit of detection and limit of quantitation for azithromycin (0.0125/0.03 mg/mL), clarithromycin (0.017/0.03 mg/mL), and clindamycin (0.038/0.06 mg/mL), with good selectivity, precision both intraday (relative standard deviation <= 1.0%) and interday (relative standard deviation < 3.7%), linearity (R-2 > 0.999) and recovery (99 - 101.7%). The method was successfully applied for the determination of azithromycin, clarithromycin and clindamycin in formulations.

Place, publisher, year, edition, pages
Wiley-VCH Verlagsgesellschaft, 2017
Keywords
azithromycin, capacitively coupled contactless conductivity detection, capillary electrophoresis, clarithromycin, clindamycin
National Category
Analytical Chemistry
Identifiers
urn:nbn:se:uu:diva-335630 (URN)10.1002/jssc.201700560 (DOI)000409436100018 ()28683179 (PubMedID)
Available from: 2017-12-12 Created: 2017-12-12 Last updated: 2017-12-12Bibliographically approved
van Tricht, E., Geurink, L., Backus, H., Germano, M., Somsen, G. W. & Sänger - van de Griend, C. (2017). One single, fast and robust capillary electrophoresis method for the direct quantification of intact adenovirus particles in upstream and downstream processing samples. Talanta: The International Journal of Pure and Applied Analytical Chemistry, 166, 8-14
Open this publication in new window or tab >>One single, fast and robust capillary electrophoresis method for the direct quantification of intact adenovirus particles in upstream and downstream processing samples
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2017 (English)In: Talanta: The International Journal of Pure and Applied Analytical Chemistry, ISSN 0039-9140, E-ISSN 1873-3573, Vol. 166, p. 8-14Article in journal (Refereed) Published
Abstract [en]

During development of adenovirus-based vaccines, samples have to be analyzed in order to either monitor the production process or control the quality and safety of the product. An important quality attribute is the total concentration of intact adenoviruses, which currently is determined by quantitative polymerase chain reaction (qPCR) or anion exchange-HPLC. Capillary Electrophoresis (CE) was evaluated as alternative to the current methods with the aim to have one single method that allows reliable and fast quantification of adenovirus particles throughout the full process. Intact adenoviruses samples from downstream processing and upstream processing were analyzed directly by CE with UV-detection at 214 nm. Only the samples with high amounts of DNA required a simple sample pretreatment by benzonase. Adenovirus particles were separated from matrix components such as cell debris, residual cell DNA, and/or proteins on a PVA-coated capillary using a BGE consisting of 125 mM Tris, 338 mM tricine and 0.2% v/v polysorbate-20 at pH 7.7. Full factorial design of experiments was used for method optimization as part of the analytical quality by design (AQbD) method development approach. The method was validated for the quantification of adenoviruses on five representative samples from the manufacturing process in the range of 0.5 x10(11)-1.5 x10(11) adenovirus particles per ml (similar to 80 to 250 pmo1/1). The CE method showed intermediate precision of 7.8% RSD on concentration and an accuracy (spiked recovery) of 95-110%. CE proved highly useful for process development support and is being implemented for in-process control testing for adenovirus vaccine manufacturing.

Keywords
Analytical Quality by Design, Capillary electrophoresis, Intact adenoviruses, Quantification, Upstream and downstream processing
National Category
Analytical Chemistry Pharmaceutical Sciences
Identifiers
urn:nbn:se:uu:diva-313285 (URN)10.1016/j.talanta.2017.01.013 (DOI)000395839700002 ()28213262 (PubMedID)
Available from: 2017-01-18 Created: 2017-01-18 Last updated: 2018-01-13Bibliographically approved
Prasanta, P., Van Laeken, C., Sänger-van de Griend, C., Adams, E. & Van Schepdael, A. (2016). CE-C4D method development and validation for the assay of ciprofloxacin. Journal of Pharmaceutical and Biomedical Analysis, 129, 1-8
Open this publication in new window or tab >>CE-C4D method development and validation for the assay of ciprofloxacin
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2016 (English)In: Journal of Pharmaceutical and Biomedical Analysis, ISSN 0731-7085, E-ISSN 1873-264X, Vol. 129, p. 1-8Article in journal (Refereed) Published
Abstract [en]

A capillary electrophoresis method with capacitively coupled contactless conductivity detection (CE-C(4)D) has been developed, optimized and validated for the determination of ciprofloxacin. Ciprofloxacin is a member of the fluoroquinolone antibiotics with a broad spectrum bactericidal activity and recommended for complicated respiratory infections, sexually transmitted diseases, tuberculosis, bacterial diarrhea etc. Method development was conducted with major focus on the quality by design (QbD) approach. During method development, multiple buffers were tried at different ionic strength. However, the optimized method finally involved a very simple background electrolyte, monosodium citrate at a concentration of 10mM without pH adjustment. The optimized CE-C(4)D method involved an uncoated fused silica capillary (59/39cm, 50μm i.d.) and hydrodynamic sample injection at a pressure of 0.5 p.s.i. for 5s. The actual separation was conducted for 10min at normal polarity with a voltage of 20kV corresponding to 5.9μA current. LiCl (1mg/mL) was used as an internal standard. The optimized method is robust and accurate (recovery >98%) which rendered the ciprofloxacin peak within five minutes with good linearity (R(2)>0.999) in the concentration range of 0.0126-0.8mg/mL. The repeatability is expressed by percentage relative standard deviation (%RSD) of the relative peak areas (RPA) and it showed good repeatability both intra-day (<3%) and inter-day (3.1%). This method, proven to be free of matrix interference, showed that the estimated percent content of ciprofloxacin (102%) was within the official requirements. Moreover, due to its ease of use and robustness, the method should also be applicable in less well controlled laboratory environments.

Keywords
Ciprofloxacin, CE-(CD)-D-4, Quality control, Pharmaceutical analysis
National Category
Pharmaceutical Sciences Analytical Chemistry
Identifiers
urn:nbn:se:uu:diva-309928 (URN)10.1016/j.jpba.2016.06.035 (DOI)000393847600001 ()27386824 (PubMedID)
Available from: 2016-12-08 Created: 2016-12-08 Last updated: 2018-01-13Bibliographically approved
El Deeb, S., Waetzig, H., El-Hady, D. A., Sänger-van de Griend, C. & Scriba, G. K. E. (2016). Recent advances in capillary electrophoretic migration techniques for pharmaceutical analysis (2013-2015). Electrophoresis, 37(12), 1591-1608
Open this publication in new window or tab >>Recent advances in capillary electrophoretic migration techniques for pharmaceutical analysis (2013-2015)
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2016 (English)In: Electrophoresis, ISSN 0173-0835, E-ISSN 1522-2683, Vol. 37, no 12, p. 1591-1608Article, review/survey (Refereed) Published
Abstract [en]

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.

Keywords
Biopharmaceuticals, Capillary electrophoresis, Pharmaceutical analysis, Quantitation
National Category
Medical Biotechnology (with a focus on Cell Biology (including Stem Cell Biology), Molecular Biology, Microbiology, Biochemistry or Biopharmacy)
Identifiers
urn:nbn:se:uu:diva-300633 (URN)10.1002/elps.201600058 (DOI)000379132300001 ()26988029 (PubMedID)
Available from: 2016-08-10 Created: 2016-08-10 Last updated: 2017-11-28Bibliographically approved
Breadmore, M. C. & Sänger van de Griend, C. E. (2014). In-capillary sample concentration in CE. LC GC North America, 32(3), 174-186
Open this publication in new window or tab >>In-capillary sample concentration in CE
2014 (English)In: LC GC North America, ISSN 1527-5949, E-ISSN 1939-1889, Vol. 32, no 3, p. 174-186Article in journal (Refereed) Published
National Category
Analytical Chemistry
Identifiers
urn:nbn:se:uu:diva-220614 (URN)
Available from: 2014-03-18 Created: 2014-03-18 Last updated: 2017-12-05Bibliographically approved
El Deeb, S., Wätzig, H., Abd El-Hady, D., Albishri, H. M., Sänger - van de Griend, C. & Scriba, G. K. E. (2014). Recent advances in capillary electrophoretic migration techniques for pharmaceutical analysis. Electrophoresis, 35(1), 170-189
Open this publication in new window or tab >>Recent advances in capillary electrophoretic migration techniques for pharmaceutical analysis
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2014 (English)In: Electrophoresis, ISSN 0173-0835, E-ISSN 1522-2683, Vol. 35, no 1, p. 170-189Article, review/survey (Refereed) Published
Abstract [en]

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.

National Category
Pharmaceutical Sciences Analytical Chemistry
Research subject
Analytical Pharmaceutical Chemistry
Identifiers
urn:nbn:se:uu:diva-214113 (URN)10.1002/elps.201300411 (DOI)000337366500013 ()
Available from: 2014-01-07 Created: 2014-01-07 Last updated: 2018-01-11Bibliographically approved
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