Evaluation of recombinant human parathyroid hormone by CZE method and its correlation with in vitro bioassay and LC methods

Maldaner, Fernanda Pavani Stamm; Perobelli, Rafaela Ferreira; Xavier, Bruna; Remuzzi, Gabriel Lunardi; Walter, Maurício Elesbão; Dalmora, Sérgio Luiz

doi:10.1016/j.talanta.2016.10.053

Cited by 10 publications

(4 citation statements)

References 19 publications

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“…Purity and stabililty of recombinant form of a fragment of human parathyroid hormone, polypeptide consisting of 34 amino acid residues, used to treat osteoporosis, was evaluated by CZE with UV detection at 200 nm in bare FS capillary (50 μm id, 48.5/40 cm total/effective length) in 50 mM sodium phosphate BGE, pH 3.0, at 20 kV separation voltage, and 25°C . The validated method with ranitidine as internal standard was linear over the concentration range 0.25–250 μg/mL, the RSDs values of the migration times and peak area ratios were 0.65 and 1.24%, respectively.…”

Section: Applicationsmentioning

confidence: 99%

Recent developments in capillary and microchip electroseparations of peptides (2015–mid 2017)

Kašička

2017

Electrophoresis

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The review brings a comprehensive overview of recent developments and applications of high performance capillary and microchip electroseparation methods (zone electrophoresis, isotachophoresis, isoelectric focusing, affinity electrophoresis, electrokinetic chromatography, and electrochromatography) to analysis, microscale isolation, purification, and physicochemical and biochemical characterization of peptides in the years 2015, 2016, and ca. up to the middle of 2017. Advances in the investigation of electromigration properties of peptides and in the methodology of their analysis (sample preseparation, preconcentration and derivatization, adsorption suppression and EOF control, and detection) are described. New developments in particular CE and CEC methods are presented and several types of their applications to peptide analysis are reported: qualitative and quantitative analysis, determination in complex (bio)matrices, monitoring of chemical and enzymatical reactions and physical changes, amino acid, sequence and chiral analysis, and peptide mapping of proteins. Some micropreparative peptide separations are shown and capabilities of CE and CEC methods to provide important physicochemical characteristics of peptides are demonstrated.

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Section: Applicationsmentioning

confidence: 99%

Recent developments in capillary and microchip electroseparations of peptides (2015–mid 2017)

Kašička

2017

Electrophoresis

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“…A CZE based method for separation of deamidation products, and a CGE method for molecular weight transformation products were developed. Other hormones such as human chorionic gonadotropin, parathyroid hormone, and recombinant human erythropoietin were also characterized for their quality attributes like pI, isoforms, stability, plasma proteolysis, and potency using CE-based methods [115][116][117][118][119][120][121][122][123][124][125][126][127].…”

Section: Analysis Of New Modality Protein Therapeuticsmentioning

confidence: 99%

Applications of capillary electrophoresis for biopharmaceutical product characterization

2021

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Capillary electrophoresis (CE), after being introduced several decades ago, has carved out a niche for itself in the field of analytical characterization of biopharmaceutical products. It does not only offer fast separation, high resolution in miniaturized format, but equally importantly represents an orthogonal separation mechanism to high‐performance liquid chromatography. Therefore, it is not surprising that CE‐based methods can be found in all major pharmacopoeias and are recommended for the analysis of biopharmaceutical products during process development, characterization, quality control, and release testing. Different separation formats of CE, such as capillary gel electrophoresis, capillary isoelectric focusing, and capillary zone electrophoresis are widely used for size and charge heterogeneity characterization as well as purity and stability testing of therapeutic proteins. Hyphenation of CE with MS is emerging as a promising bioanalytical tool to assess the primary structure of therapeutic proteins along with any impurities. In this review, we confer the latest developments in capillary electrophoresis, used for the characterization of critical quality attributes of biopharmaceutical products covering the past 6 years (2015–2021). Monoclonal antibodies, due to their significant share in the market, have been given prioritized coverage.

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“…The assay was performed as described elsewhere (Maldaner et al, 2017) based on the neutral red uptake (NRU) assay, with the NCTC clone 929 cell line (mammalian fibroblasts, ATCC ® No. CCL-1™) exposed to altered samples of rhIFNβ-1b.…”

Section: In Vitro Cytotoxicity Testmentioning

confidence: 99%

Evaluation of recombinant human interferon beta 1b by liquid chromatography methods and bioassay

Silva

Walter

Xavier

et al. 2019

Braz. J. Pharm. Sci.

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Recombinant human interferon beta 1b (rhIFNβ−1b) is clinically used to treat multiple sclerosis. A reversed−phase liquid chromatography (RP−LC) method was carried out on a Jupiter C 4 column (250 mm × 4.6 mm i.d.). The mobile phase A consisted of 0.1% trifluoroacetic acid (TFA) in water, and the mobile phase B was acetonitrile with 0.1% TFA run at a flow rate of 1.0 mL/min. A size exclusion liquid chromatography (SE−LC) method was carried out on a BioSep−SEC−S 2000 column (300 mm × 7.8 mm i.d.). The mobile phase consisted of 1 mM monobasic potassium phosphate, 8 mM sodium phosphate dibasic and 200 mM sodium chloride buffer pH 7.4, run isocratically at a flow rate of 0.8 mL/min. Retention times were 31.87 and 17.78 min, and calibration curves were linear over the concentration range of 1−200 µg/mL (r 2 = 0.9998) and 0.50−200 µg/mL (r 2 = 0.9999), respectively, for RP−LC and SE−LC, with detection at 214 nm. Liquid chromatography (LC) methods were validated and employed in conjunction with the in vitro bioassay to assess the content/potency of rhIFNβ−1b, contributing to improve the quality control and to ensure the efficacy of the biotherapeutic.

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Evaluation of recombinant human parathyroid hormone by CZE method and its correlation with in vitro bioassay and LC methods

Cited by 10 publications

References 19 publications

Recent developments in capillary and microchip electroseparations of peptides (2015–mid 2017)

Recent developments in capillary and microchip electroseparations of peptides (2015–mid 2017)

Applications of capillary electrophoresis for biopharmaceutical product characterization

Evaluation of recombinant human interferon beta 1b by liquid chromatography methods and bioassay

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