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HPLC (Biocompatible) HPLC-CAD UHPLC LCMSMS

BioPharma

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Biosimilar product Buffer Digest Drug product Formulation Buffer Human IgG serum N/A NIST standard Rituximab drug product 10 mg/mL (MabThera®) Water

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A1 A2 A2[3]G1 A2[6]G1 A2G2 A2G2S1 A2G2S2 A3 Acidic Component 1 Acidic Component 2 Acidic Component 3 Acidic Component 4 Acidic Component 5 ADYEK ADYEKHKVYACEVTHQGLSSPVTK Aggregate Aggregates ALPAPIEK ALTYY ALTYYDYEFAYWGQGTLVTVSAASTK ASQSIGTNIHWY ASQSIGTNIHWYQQR AYWGQGTLVTVSAASTK Basic Component 1 Basic Component 2 Basic Component 3 Basic Component 4 Basic Component 5 Basic Component 7 Basic Component 8 Bevacizumab Bevacizumab-Aggregate Carbonic anhydrase cetuximab Cytochrome C DILLTQSPVIL DILLTQSPVILSVSPGER DILLTQSPVILSVSPGERVSFSCR DILLTQSPVILSVSPGERVSFSCRASQSIGTNIHWYQQR DSTYSLSSTLTLSK DTLMISR DYEFAYWGQGTLVTVSAASTK DYFPEPVTVSWN DYFPEPVTVSWNSGALTSGVH EEMTK EEMTKNQVSLTCLVK EPQVY EPQVYTLPPSR EPQVYTLPPSREEMTK EPQVYTLPPSREEMTKNQVSLTCLVK FA1 FA1[3]G1 FA1[3]G1: FM4A1 FA1[6]G1 FA1G1Ga1 FA1G1S1 FA1G1Sg1 FA2 FA2: A1G1 FA2[3]G1 FA2[6]G1 FA2[6]G1Sg1 FA2B: A2[6]G1 FA2B[3]G1 FA2B[6]G1 FA2BG2 FA2BG2S1 FA2BG2S2 FA2G1S1 FA2G2 FA2G2S1 FA2G2S2 FA2G2Sg1 FA3 FA4 FM4A1G1: FM5A1 FM4A1G1; FM5A1 FM4A1G1Sg1 FM5A1G1 FM5A1G1Sg1 FNWY FNWYVDGVEVHNAK Fragment 1 Fragment 2 FSGSGSGTDFTLSINSVESEDIADYYCQQNNNWPTTFGAGTK GFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSK GLEWLGVIW GLEWLGVIWSGGNTDYNTPFTSR GPSVFPLAPSSK GQGTLVTVSAASTK GVHWVR HKVYACEVTHQGLSSPVTK IFPPSDEQLK Infliximab M5 M8 M9 NISTmAB (RM 8671) NQVSLTCLVK TVAAPSVFIFPPSDEQLK

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Class

Aggegate biotherapeautic biotherapeautic degradation product Biotherapeutic Charge Variant Charge Variant. Fragment IgG1 IgG1 Mab Immunoglobulin Impurity monoclonal antibody N-Glycan Peptide Protein

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Manufacturer

Thermo Fisher Scientific Thermo Scientific

Model

Acclaim 120 C18 RSLC Accucore Accucore 150 Amide HILIC Accucore 150 HILIC-Amide Accucore 150-Amide-HILIC Hypersil GOLD MAbPac SCX-10 MAbPac SEC-1 MabPac-SCX 10

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Stationary Phase

300 Å proprietary diol Amide C18 C18 Selectivity Fused Core HILIC polystyrene 2% cross-linked with divinylbenzene Prorietary diol Silica Solid core silica strong cation exchange

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Displaying 1-5 of 17 results for: NIBRT

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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.

sec protein aggregate analysis

SEC Protein aggregate analysis

Instrument Type: UHPLC

A UHPLC workflow for mAb aggregate analysis that operates continuously for weeks.

automated peptide mapping

High-precision, automated peptide mapping of proteins

Instrument Type: UHPLC

The biopharmaceutical industry continues to develop protein-based biotherapeutics in increasing numbers. Due to their complexity and biotechnological production, there are many attributes that need to be analyzed to guarantee their safety and efficacy. Peptide mapping is used to measure several critical quality attributes (CQA) required for the characterization of any biotherapeutic protein. The analysis is used to confirm that the correct sequence has been expressed for the protein and to check for post-translational and chemical modifications.

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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