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HPLC (Biocompatible) HPLC-CAD UHPLC LCMS Unspecified

BioPharma

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

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a1 A-1a A-1b a2 A-2 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 B-1a B-1b B-1c B2 B-2 B-3 B-4 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 G0_G0F G0F_G0F G0F_G1F G1F_G1F G1F_G2F host cell material IgG-1 Infliximab M M-1a M-1b M-1c mAb 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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1x deamidation 1x Lys 1x Lys, 1x deamidation 1x Lys, sialylated glycans 2x Lys 2x Lys, sialylated glycans acidic mAb variant basic mAb variant Charge Variant Charge Variant. IgG1 IgG-1 IgG1 Mab IgG-2 impurities Impurity mAb mAb variant monoclonal antibody no modification Peptibody protein sialylated glycans

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Manufacturer

Thermo Fisher Scientific Thermo Scientific

Model

MAbPac CX-10 RS MAbPac Protein A MAbPac RP MAbPac SCx 10 MAbPac SCX-10 MabPac SCX-10 RS MAbPac SEC-1 MabPac-SCX 10 ProPac 3R SCX 3 µm

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Stationary Phase

Non porous pellicular resin Phenyl polystyrene 2% cross-linked with divinylbenzene Proprietary Prorietary diol Protein A SCX Strong Cation Exchange

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Displaying 1-5 of 16 results for: charge variant

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monitoring multiple quality attributes intact monoclonal antibodies from bioreactors by switchable 2dlcms

Monitoring of multiple quality attributes of intact monoclonal antibodies from bioreactors by switchable 2D-LC-MS

Instrument Type: LCMS

The presented 2D-LC-MS system facilitates the straightforward analysis of mAb producing cell culture samples for the upstream monitoring of titer, charge variants, and size variants of the intact antibody. While the first dimension purifies the mAb from matrix components by Protein A affinity chromatography, selectable second dimension mechanisms enable the assessment of the aggregation level by SEC or the abundance monitoring of glycoforms and other variants by SCX.

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.

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