BiopharmaceuticalCharactarization230x195

Confident protein characterization methods

Get the latest information on the analysis of biotherapeutic proteins such as monoclonal antibodies (mAbs) in their intact form. UHPLC is ideal for identifying modifications such as charge variants, as well as higher order structures through aggregation. Use our broad range of leading column chemistries for these and other intact analyses by liquid chromatography (LC). For rapid and precise accurate mass determination, try our uniquely powerful Thermo Scientific Orbitrap-based mass spectrometers (MS) for analysis of both denatured and native intact proteins.

Contact us  Receive updates  Join community


On this page


NEW intact protein chromatography built for biopharma

New Vanquish Flex UHPLC delivers confidence, with a fully bio-compatible flow path and proven compliance. Achieve unprecedented performance in retention time stability, sensitivity and separation efficiency with the widest range of column chemistries for biotherapeutic protein characterization. Demand versatility through seamless integration with market-leading mass spectrometry, fluorescence and charged aerosol detection. Gain operational simplicity with easy, freely available, one-click workflows via AppsLab and tool-free Viper fittings.


Orbitrap mass spectrometers for intact protein analysis workflows

 Orbitrap Exploris 480 Mass SpectrometerOrbitrap Eclipse Tribrid Mass SpectrometerQ Exactive BioPharma Platform
 Orbitrap Exploris 480 Mass SpectrometerOrbitrap Eclipse Tribrid Mass SpectrometerQ Exactive BioPharma Platform
AdvantagesExtraordinary simplified within a compact footprint where next level exploration delivers quantifiable accuracy and the selectivity required to obtain richer insights, empowering all by bringing performance and intelligence together to provide rapid confirmation of intact protein molecular weight and determine glycoform heterogeneity of biopharmaceuticals.Go beyond today's discovery with new innovations that deliver the ultimate flexibility to expand experimental scope, with built-in intelligence to ensure the highest data quality and confidence when confirming intact protein molecular weight and determining glycoform heterogeneity of biopharmaceuticals.Realize complete BioPharma characterization with a mass spectrometer which offers distinct operational modes optimized for the top three protein characterization workflows.
Resources
Resolving power480,000 at m/z 1957,500-500,000 FWHM at m/z 200 (1M option)Up to 240,000 at m/z 200
Scan speedUp to 40HzUp to 40Hz18Hz
Mass range40 to 6,000 m/z (up to 8,000 m/z with the BioPharma option)50 to 6,000 (up to 8,000 with HMRn)50 to 8,000 m/z
Dynamic range>5000:1>5000 with a single OTMS spectrum>5000:1
Mass accuracyInternal <1 ppm RMS; External: <3 ppm RMSInternal <1 ppm RMS; External: <3 ppm RMSInternal <1 ppm RMS; External: <3 ppm RMS

Featured software for intact protein analysis workflows

Powerful, yet simple protein deconvolution and peptide mapping software

Screen, identify, and characterize intact proteins with higher productivity and confidence using the Intact Protein workflow in BioPharma Finder software. Two deconvolution algorithms take full advantage of the high-quality HRAM data produced by Orbitrap mass spectrometers. In addition to intact characterization, you can confirm amino acid sequence, identify site and type of known/unknown post translational modifications, while providing relative amounts using Peptide Mapping workflows. Additional features include disulfide linkage, sequence variant analysis, and sequence alterations.


Quickly confirm intact protein molecular weight and determine glycoform heterogeneity of biopharmaceuticals. High-resolution accurate-mass (HRAM) mass spectrometry is a vital tool for intact protein mass analysis, enabling a direct comparison of biotherapeutics products throughout the drug pipeline.

Perform robust analysis of charge variants in monoclonal antibodies. The charge heterogeneity of a biotherapeutic protein strongly influences the stability and efficacy of the drug. Learn about our range of pH buffers, ion exchange chromatography (IEX) column chemistries and UHPLC instrumentation required for full charge variant profiling.

Protein aggregation gives rise to higher order structures which can significantly affect the efficacy of biologic drugs and cause harmful side effects. Discover the leading size exclusion chromatography (SEC) solutions available to ensure confident characterization of sub-visible protein aggregates in biotherapeutic formulations.

Perform selective digestion of mAbs to antibody fragments and simplify your analysis. Find products for chromatography of protein fragments and see how the resolving power of the Orbitrap mass analyzers ensures resolution of subunits of proteins and facilitates top/middle down sequencing.

Intact protein analysis under native mass spectrometry conditions preserves structurally-critical non-covalent binding between antibody chains. Providing the ideal technique to aid characterization of antibody drug conjugates (ADCs) and other heterogeneous antibody samples. Find out more about our routine native analysis columns and on-line size exclusion chromatography (SEC).

Determination of protein concentration, known as titer, is widely used in the biotechnological protein production process. Choose from our wide range of affinity columns and resins from discovery to QA/QC for titer measurement. Our range of protein-A protein purification columns can automate biopharmaceutical protein isolation ahead of additional characterization steps, such as charge variant profiling.


Featured video

Prof. Alexander Makarov takes us through the evolution of Obitrap technology for the analysis of biotherapeutics.


Resources

Application notes & Posters