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Instrument Type

HPLC (Biocompatible) HPLC-CAD UHPLC Unspecified

BioPharma

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Aqueous solution Drug product Formulation Buffer N.A N/A NA NIST standard Water

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Name

Acidic Component 1 Acidic Component 2 Acidic Component 3 Acidic Component 4 Acidic Component 5 Acidic Variant-1 Acidic Variant-2 Acidic Variant-3 Acidic Variant-4 Acidic Variant-5 Acidic Variant-6 Acidic Variant-7 Acidic Variant-8 Acidic Variant-9 Basic Component 1 Basic Component 2 Basic Component 3 Basic Component 4 Basic Component 5 Basic Component 7 Basic Component 8 Basic Variant-1 Basic Variant-2 Basic Variant-3 Basic Variant-4 Basic Variant-5 Basic Variant-6 Basic Variant-7 Basic Variant-8 Bevacizumab cetuximab Component 1 Component 10 Component 11 Component 2 Component 3 Component 4 Component 5 Component 6 Component 7 Component 8 Component 9 Denosumab IgG-1 infliximab NISTmAB (RM 8671) PostPeak 1 Pre Peak 1 Pre Peak 2 Pre Peak 3 Pre Peak 4 PrePeak 1 PrePeak 2 PrePeak 3 PrePeak 4 PrePeak 5 PrePeak 6 PrePeak 7 Ranibizumab Romiplostim trastuzumab

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Class

Charge Variant Charge Variant. IgG1 IgG-1 IgG1 Mab IgG-2 impurities Impurity mAb monoclonal antibody Peptibody protein

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Manufacturer

Thermo Fisher Scientic Thermo Fisher Scientific Thermo Scientific

Model

MAbPac CX-10 RS MAbPac SCx 10 MAbPac SCX-10 MabPac SCX-10 RS MabPac-SCX 10

Stationary Phase

Non porous pellicular resin polystyrene 2% cross-linked with divinylbenzene SCX strong cation exchange

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Displaying 1-5 of 14 results for: charge variant

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charge variant analysis ranibizumab sample using volatile buffer strong cation exchange column

Charge variant analysis of Ranibizumab sample using volatile buffer and strong cation exchange column.

Instrument Type: HPLC (Biocompatible)

The Thermo Scientific Dionex UltiMate 3000 LC Bio-LC system is applied for the Ion Exchange analysis of ranibizumab sample. The separation was performed on a Thermo Scientific MAbPac SCX-10 with a UV detection at 280 nm.

separation charge variants romiplostim by ion exchange chromatography using strong cation exchange column

Separation of charge variants of romiplostim by Ion Exchange chromatography using strong cation exchange column

Instrument Type: HPLC (Biocompatible)

The Thermo Scientific Dionex UltiMate 3000 LC Bio-LC system is applied for the Ion Exchange analysis of romiplostim i.e peptibody. The separation was performed on a Thermo Scientific MAbPac SCX-10 with a UV detection at 210 nm.

Simple charge variant profile comparison of an innovator monoclonal antibody and a biosimilar candidate

Instrument Type: UHPLC

To demonstrate the effectiveness of a simple pH gradient/ion-exchange chromatography workflow approach to the characterization of charge variant profiles of an innovator molecule (cetuximab) and a candidate biosimilar. To show the assay is simple, reproducible, easily optimized and resolves variants effectively.

phbased gradients for charged variant analysis

Evaluation and application of salt- and pH-based ion-exchange chromatography gradients for analysis of therapeutic monoclonal antibodies

Instrument Type: UHPLC

To demonstrate the CX-1 pH buffer system is capable of charge variant determination for the majority of therapeutic monoclonal antibody species. To show the ease of optimization and improved reproducibility of this buffer system when compared to salt-based gradient systems used for charge variant analysis.

charge variant analysis nist mab

High resolution charge variants analysis of recombinant human IgG1K NIST mAb

Instrument Type: HPLC-CAD

The Thermo Scientific Vanquish Flex UHPLC system with UV detection is applied for the charge variants analysis of NISTmAb Humanized IgG1K monoclonal antibody using strong cation exchange-based chromatographic separation on a MAbPac SCX-10 column. The use of Thermo Scientific CX-1 pH gradient buffers enabled high resolution separation of reference material monoclonal antibody charge variants using a 30 minute gradient.

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