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HPLC (Biocompatible) HPLC-CAD UHPLC LCMS Unspecified

BioPharma

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

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a1 A-1 A-1a A-1b a2 A-2 a3 A-3 A-4 A-5 A-6 Acidic 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-1 B-10 B-11 B-12 B-1a B-1b B-1c B2 B-3 B-4 B-5 B-6 B-7 B-8 B-9 Basic 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 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 Neutral 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 Tocilizumab

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Class

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. charge variants IgG1 IgG-1 IgG1 Mab IgG-2 impurities Impurity mAb mAb variant Main Peak 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 POROS A 20 μm Protein A Affinity Propac 3R SCX ProPac 3R SCX 3 µm ProPac™ 3R SCX 3 μm

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Stationary Phase

Non porous pellicular resin Phenyl polystyrene 2% cross-linked with divinylbenzene Proprietary Proprietary diol Prorietary diol Protein A Recombinant Protein A SCX Size Exclusion strong cation exchange

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Displaying 1-5 of 19 results for: charge variant

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enabling online monitoring mab titer product quality bioreactors with an aseptic autosamplerready hplc configuration as pat tool

Enabling online monitoring of mAb titer and product quality in bioreactors with an aseptic autosampler-ready HPLC configuration as PAT tool

Instrument Type: UHPLC

The integration of Thermo Scientific Vanquish HPLC and UHPLC Systems with an aseptic autosampler enables automated online sample delivery and analysis for pseudo real-time monitoring of protein titer and critical quality attributes (CQAs) during upstream process development.

monitoring monoclonal antibody bioproduction processes with 2dlcuv

Monitoring monoclonal antibody bioproduction processes with 2D-LC-UV

Instrument Type: HPLC (Biocompatible)

The switchable heart-cut 2D-LC system facilitates the straightforward at-line 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 charge variants by SCX.

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.

charge related impurity anaysis tocilizumab

Charg varient Analysis of Tocilizumab

Instrument Type: UHPLC

The Thermofisher Scientific Vanquish™ Flex UHPLC system was used to analyze Tocilizumab Charge variant analysis using Propac 3R SCX Column and CX-1 Buffer

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.

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