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HPLC (Biocompatible) HPLC-CAD UHPLC LCMS Unspecified

BioPharma

Yes No

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

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Name

a1 a2 a3 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 B1 b2 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 M 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

1x deamidation 1x Lys 1x Lys, 1x deamidation 1x Lys, sialylated glycans 2x Lys 2x Lys, sialylated glycans Charge Variant Charge Variant. IgG1 IgG-1 IgG1 Mab IgG-2 impurities Impurity mAb monoclonal antibody no modification Peptibody protein sialylated glycans

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Manufacturer

Thermo Fisher Scientific Thermo Scientific

Model

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

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Stationary Phase

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

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Displaying 1-5 of 15 results for: charge variant

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intact 2dlcms mab charge variants

Intact mass analysis of monoclonal antibody charge variants by multi heart-cut 2D-LC/MS coupling ion-exchange and reversed-phase chromatography

Instrument Type: LCMS

Multiple heart-cut 2D-LC-MS is an efficient approach for charge variant analysis of antibodies by enabling direct MS analysis of first dimension ion-exchange fractions after desalting in the second dimension. Intact mass analysis facilitates identification and monitoring of mAb charge variant patterns. Annotations of major and minor charge variant peaks could be proposed. Enrichment of one fraction was used to improve the MS signal intensity.

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.

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