Development of a high performance size exclusion chromatography method to determine the stability of Human Serum Albumin in a lyophilized formulation of Interferon alfa-2b

Qian, Jin; Tang, Qinglin; Cronin, Bart; Markovich, Robert J.; Rustum, Abu M.

doi:10.1016/j.chroma.2008.01.040

Cited by 30 publications

(17 citation statements)

References 24 publications

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“…Ogasawara et al used SDS-PAGE and Western blot analyses to detect albumin disulfide dimers in plasma, considered to be a biomarker of oxidative stress [66]. More recently, Qian et al (2008) reported a size exclusion HPLC method to estimate the proportion of HSA dimers and oligomers suitable for a quality control [67]. MS and MS coupled to HPLC also have been employed to characterize different variants of HSA in commercial HSA preparations.…”

Section: Reviewmentioning

confidence: 99%

Specific antioxidant properties of human serum albumin

et al. 2013

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Human serum albumin (HSA) has been used for a long time as a resuscitation fluid in critically ill patients. It is known to exert several important physiological and pharmacological functions. Among them, the antioxidant properties seem to be of paramount importance as they may be implied in the potential beneficial effects that have been observed in the critical care and hepatological settings. The specific antioxidant functions of the protein are closely related to its structure. Indeed, they are due to its multiple ligand-binding capacities and free radical-trapping properties. The HSA molecule can undergo various structural changes modifying its conformation and hence its binding properties and redox state. Such chemical modifications can occur during bioprocesses and storage conditions of the commercial HSA solutions, resulting in heterogeneous solutions for infusion. In this review, we explore the mechanisms that are responsible for the specific antioxidant properties of HSA in its native form, chemically modified forms, and commercial formulations. To conclude, we discuss the implication of this recent literature for future clinical trials using albumin as a drug and for elucidating the effects of HSA infusion in critically ill patients.

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Section: Reviewmentioning

confidence: 99%

Specific antioxidant properties of human serum albumin

et al. 2013

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“…[76,83] Near UV or longer wavelengths give greater response for aromatic amino acids, such as tryptophan, and are commonly used for protein measurement. [84] Higher sensitivity provided by detection using far UV or low wavelengths (214 or 220 nm), where the amide peptide bond has a strong absorbance.…”

Section: Detectorsmentioning

confidence: 99%

A Review Size-Exclusion Chromatography for the Analysis of Protein Biotherapeutics and Their Aggregates

Hong

Koza

Bouvier

2012

Journal of Liquid Chromatography & Related Technologies

445

291

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In recent years, the use and number of biotherapeutics has increased significantly. For these largely protein-based therapies, the quantitation of aggregates is of particular concern given their potential effect on efficacy and immunogenicity. This need has renewed interest in size-exclusion chromatography (SEC). In the following review we will outline the history and background of SEC for the analysis of proteins. We will also discuss the instrumentation for these analyses, including the use of different types of detectors. Method development for protein analysis by SEC will also be outlined, including the effect of mobile phase and column parameters (column length, pore size). We will also review some of the applications of this mode of separation that are of particular importance to protein biopharmaceutical development and highlight some considerations in their implementation.

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“…Although each of the mentioned compounds has been extensively studied and information about them can be found in the literature [10][11][12][13][14][15], no method for the simultaneous determination of HSA and TM has been reported up to the present day.…”

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confidence: 99%

RP-HPLC method development for the simultaneous determination of timolol maleate and human serum albumin in albumin nanoparticles

Boiero

Allemandi

Longhi

et al. 2015

Journal of Pharmaceutical and Biomedical Analysis

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An isocratic high-performance liquid chromatographic method was developed and validated for the simultaneous determination of human serum albumin (HSA) and timolol in albumin nanoparticles. This method involved a reversed-phase-C18 column thermostated at 25 °C, UV detection at 276 nm, flow rate of 1.0 ml/min and a mobile phase compounded by 0.05% (v/v) trifluoroacetic acid in water/0.05% (v/v) trifluoroacetic acid in an acetonitrile (40:60, v/v) solution. The elution times for albumin and timolol were 1.84 ± 0.05 min and 2.67 ± 0.04 min, respectively. Calibration curves were linear from 0.2 to 100 mg/ml for HSA and 0.01 to 1 mg/ml for timolol. Limits of quantification were 0.2 mg/ml for HSA and 0.01 mg/ml for timolol. The values of accuracy and precision of intra- and inter-day variation studies were within acceptable limits, according to the US Food and Drug Administration Guidance for Industry. The described method has proved to be useful to give accurate measurements of human serum albumin and timolol from albumin nanoparticles to determine the percentage of encapsulation and the process yield.

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Development of a high performance size exclusion chromatography method to determine the stability of Human Serum Albumin in a lyophilized formulation of Interferon alfa-2b

Cited by 30 publications

References 24 publications

Specific antioxidant properties of human serum albumin

Specific antioxidant properties of human serum albumin

A Review Size-Exclusion Chromatography for the Analysis of Protein Biotherapeutics and Their Aggregates

RP-HPLC method development for the simultaneous determination of timolol maleate and human serum albumin in albumin nanoparticles

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