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Displaying 1-17 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.

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

Instrument Type: UHPLC

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

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.

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.

Ultrafast hydrophilic interaction UHPLC analysis of 2AA labelled N-glycans from monoclonal antibodies (mAbs)

Instrument Type: UHPLC

The Thermo Scientific Vanquish UHPLC system with Fluorescence detection is applied for the rapid glyco-profiling of a commercial chimeric IgG1 mAb.The separation is performed on a Thermo Scientific Accucore-150-Amide HILIC column in under 2.5 minutes. The developed methodology offers an excellent analytical platform for ultrafast glycan profile comparison of different batches​ of these mAbs.

Rapid sample preparation and peptide mapping analysis of top-selling monoclonal antibody therapeutics

Instrument Type: LCMSMS

The Thermo Scientific SMART Digest Kit is applied for generation of peptides from therapeutic monoclonal antibodies in 60 minutes. Peptide mapping samples were analysed on a Thermo Scientific UltiMate U3000 RSLC system coupled to a Thermo Scientific Q Exactive HF with Biopharma Option. Separation of sample peptides was performed on a Thermo Scientific Acclaim RSLC 120, C18, 2.2 µm analytical column using a 30 minute separation gradient, yielding excellent chromatographic separation and high sequence coverage.

High resolution charge variant analysis of Cetuximab by ion exchange chromatography using pH gradient buffers

Instrument Type: HPLC (Biocompatible)

The Thermo Scientific MAbPac SCX-10 column is applied to the charge variant analysis of Cetuximab. Ion exchange separation was performed using a pH gradient on a Thermo Scientific Vanquish Flex UHPLC system with UV detection at 280 nm. Use of Thermo Scientific CX-1 pH gradient buffers enabled high resolution separation of monoclonal antibody charge variants over a 30 minute gradient.

High resolution charge variant analysis of Infliximab by ion exchange chromatography using pH gradient buffers

Instrument Type: HPLC (Biocompatible)

The Thermo Scientific MAbPac SCX-10 column is applied for charge variant analysis of Infliximab. Ion exchange separation was performed on a Vanquish Flex UHPLC system using a pH gradient and UV detection at 280 nm. Use of Thermo Scientific CX-1 pH gradient buffers enabled high resolution separation of monoclonal antibody charge variants over a 30 minute gradient.

High resolution charge variant analysis of Bevacizumab by ion exchange chromatography using pH gradient buffers

Instrument Type: HPLC (Biocompatible)

Ion exchange separation is applied for charge variant analysis of Bevacizumab using a pH gradient on a Thermo Scientific MAbPac SCX-10 column. The Thermo Scientific Vanquish Flex UHPLC system with UV detection at 280 nm was used with Thermo Scientific CX-1 pH gradient buffers enabled high resolution separation of monoclonal antibody charge variants over a 30 minute gradient.

In-depth protein glycosylation comparison of a biosimilar candidate by hydrophilic interaction UHPLC

Instrument Type: UHPLC

The Thermo Scientific Vanquish H system with fluorescence detection is applied for the glycan profile comparison of a biosimilar candidate produced ‘in house’ using Chinese hamster ovary (CHO) cell line using HILIC-based chromatographic separation on Accucore 150-Amide-HILIC column. Developed methodology offers an excellent analytical platform for glycan profile comparison of multiples lots of the biosimilar product.

Ultrafast hydrophilic interaction UHPLC analysis of 2-AA labelled N-glycans from monoclonal antibodies (mAbs)

Instrument Type: UHPLC

The Thermo Scientific Vanquish H system with fluorescence detection is applied for the rapid glycoprofiling of a commercial chimeric IgG1 mAb. The separation is performed on a Thermo Scientific Accucore-150-Amide HILIC column in under 2.5 minutes. Developed methodology offers an excellent analytical platform for ultrafast glycan profile comparison of various production batches.

In-depth protein glycosylation comparison of an innovator monoclonal antibody by hydrophilic interaction UHPLC

Instrument Type: UHPLC

The Thermo Scientific Vanquish H UHPC with Fluorescence detection is applied for the glycan profile comparison of trastuzumab innovator to a biosimilar candidate produced ‘in house’ using Chinese hamster ovary (CHO) cell line using HILIC-based chromatographic separation on Accucore 150-Amide-HILIC column. Developed methodology offers an excellent analytical platform for glycan profile comparison of multiples lots of both the innovator and biosimilar products

A high resolution separation of 2-AA derivatized N-Glycans from a commercial chimeric IgG1 monoclonal antibody (Infliximab)

Instrument Type: UHPLC

The Thermo Scientific Vanquish H UHPLC system was used for the high resolution determination of 2-AA (anthranilic acid) labelled N-glycans released from a commercial chimeric IgG1 mAb (Infliximab). The separation is performed on a 150 mm Accucore 150-Amide-HILIC column with fluorescence detection giving separation in less than 30 minutes.N-Glycans present at the asparagine 297 residue in the CH2 domain of the Fc region of IgG play a crucial role in modulating the structural stability and functional activity relationship of the antibody.

A fast separation of 2-AB labelled N-Glycans from polyclonal human serum IgG
(1)

Instrument Type: UHPLC

The Thermo Scientific Vanquish H UHPLC system is applied for the rapid determination of 2-AB (2-aminobenzamide) labelled N-glycans released from human serum IgG in less than 15 minutes using a 50 mm Thermo Scientific Accucore 150-Amide-HILIC column with fluorescence detection. The method is able to determine N-Glycans present at the asparagine 297 residue in the CH2 domain of the Fc region of IgG that play a crucial role in modulating the structural stability and functional activity relationship of the antibody.

A universal chromatography method for aggregate analysis of monocolonal antibodies

Instrument Type: UHPLC

Analysis of protein aggregation of five important biotherapeutic monoclonal antibodies (mAbs) by size-exclusion chromatography, showing the universal applicability of the Thermo Scientific MAbPac SEC-1 column for aggregate analysis of mAbs. The biopharmaceutical industry continues to develop mAb-based biotherapeutics have several key quality attributes that require quantification. This shows the ability to determine quickly and accurately the percentage of aggregates and fragments for five therapeutics as shown with full details in the AN21601 download.

Setting the correct UHPLC instrument connections for protein aggregate analysis by size-exclusion chromatography

Instrument Type: UHPLC

The importance of correct UHPLC instrument setup for protein aggregate analysis by size-exclusion chromatography is shown by using the Thermo Scientific Vanquish Flex Quaternary UHPLC system. For this analysis, pre-column dispersion was reduced to show the effects of dispersion in front of the column at different flow rates. After the flow rates are reduced to 300 μL/min with the MAbPac-SEC-1 column formats of 4 mm i.d., the use of low volume tubing and fittings becomes essential in order to maintain resolution of aggregates from the main peak. Refer to attached pdf file for full experiment.