2014
DOI: 10.2116/analsci.30.483
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Application of Microchip Electrophoresis Sodium Dodecyl Sulfate for the Evaluation of Change of Degradation Species of Therapeutic Antibodies in Stability Testing

Abstract: We evaluated the performance of a commercial microchip electrophoresis instrument (LabChip ® GXII) for the evaluation of change of degradation species of therapeutic antibodies in stability testing. This system requires a sample volume of only 5 μg, and indicates fine resolution of size variant species such as light chain, heavy chain, non-glycosylated heavy chain and various degradation species. Precision and accuracy were high; the intermediate precision of 18 determinations was only 2.1% or less as RSD and … Show more

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Cited by 15 publications
(8 citation statements)
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“…They adapted CGE method for quality analysis under reducing conditions [51]. Finally, Yagi et al proposed a quality control of mAbs using microchip electrophoresis sodium dodecyl sulfate (ME-SDS) [52]. The intrinsic properties of the microchip (separation channel measuring 14 mm in length and 31 µm in width, high efficiency) make the ME-SDS a powerful methods in terms of minimized analysis time (< 40s).…”
Section: Applicationsmentioning
confidence: 99%
“…They adapted CGE method for quality analysis under reducing conditions [51]. Finally, Yagi et al proposed a quality control of mAbs using microchip electrophoresis sodium dodecyl sulfate (ME-SDS) [52]. The intrinsic properties of the microchip (separation channel measuring 14 mm in length and 31 µm in width, high efficiency) make the ME-SDS a powerful methods in terms of minimized analysis time (< 40s).…”
Section: Applicationsmentioning
confidence: 99%
“…During evaluation of the DOE results, consideration was given to whether the platform method could meet the requirements of the ATP using the default instrument parameters provided in the assay scripts. The critical method parameters for evaluation by DOE were selected for evaluation based on early development data, literature references [8][9][10][11][12][15][16][17], and an analytical risk assessment [19]: DTT concentration (reduced samples), heating time, heating temperature, reduced/non-reduced sample buffer volume, and protein load ( Table 1). These parameters were chosen based on the hypothesis that their optimization would produce (i) consistent peak profiles over many runs due to optimized denaturation and reduction conditions, (ii) consistent sensitivity and detection of low-abundance variants due to the optimization of the protein load, and (iii) data demonstrating whether sample preparation conditions substantially impact resolution, which cannot be otherwise optimized without a custom assay script.…”
Section: Determination Of Platform Methods Design Space Via Design Of mentioning
confidence: 99%
“…CE-SDS was commercially available for many years prior to the introduction of M-CGE technologies to the marketplace, making it the only option for organizations endeavoring to replace conventional SDS-PAGE with CE in their QC release and stability labs. A more recently introduced technology, M-CGE, provides higher throughput than CE-SDS through rapid separation times of less than one minute per sample while offering similar resolution, sensitivity, and quantitation capabilities to CE-SDS [16,17]. In recent years M-CGE methods have been increasingly utilized throughout industry to support process and product development, primarily because of their superior throughput capabilities; however CE-SDS remains the more commonly utilized technology for GMP release and stability testing.…”
Section: Introductionmentioning
confidence: 99%
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“…Similar resolving power has been demonstrated when analyzing the degradation species of thermally stressed mAbs under regular CGE and microchip CGE. In that particular study performed with commercial instrumentation, the analysis time was reduced by a factor of 20 . As an alternative to microchip CGE, multicapillary gel electrophoresis (mCGE) systems with covalent fluorescent labeling were developed, allowing highly sensitive and fast analysis of mAbs (purity assessment and subunit characterization) …”
Section: Electrophoretic Approachesmentioning
confidence: 99%