Intact and Subunit Protein Analysis Solutions

Intact and Subunit Protein Analysis Solutions

Achieve fast and accurate intact mass and subunit protein analysis solutions for structural confirmation, modifications, and glycoform heterogeneity with Waters technologies.  Elevate your lab’s productivity with useful protein structural insights using compliant-ready hardware and software solutions along with robust columns, specifically QC batch-tested with relevant proteins.

 

Achieve fast and accurate intact mass and subunit protein analysis solutions for structural confirmation, modifications, and glycoform heterogeneity with Waters technologies.  Elevate your lab’s productivity with useful protein structural insights using compliant-ready hardware and software solutions along with robust columns, specifically QC batch-tested with relevant proteins.

 

Intact Protein Analysis
Intact Protein Analysis

Overview

Waters workflow solutions deliver quick and accurate intact protein measurement for confirmation of identity, modifications, and glycoform heterogeneity, and include:

  • MaxPeak Premier Solutions to maximize separations performance and consistency with purposefully designed chromatography systems and consumables
  • Xevo G3 QTof and BioAccord System for robust, powerful characterization and monitoring to reliably generate intact mass data and elevate your laboratory’s productivity
  • SYNAPT XS and SELECT SERIES Cyclic IMS to perform in depth protein characterization and differentiate between conformations with flexible fragmentation and ion mobility separation
  • waters_connect informatics for a compliance ready, app- based software platform, enabling easy method sharing, and data management

Applications

Mass spectrometry and light scattering techniques can provide multiple quality attributes of proteins throughout the development and manufacture process. This can be performed at the intact protein or subunit level and may involve identity, characterizing post-translational modifications (such as oxidation, glycosylation and PEGylation), impurity analysis, and oligomer characterization.

Mass spectrometry and light scattering techniques can provide multiple quality attributes of proteins throughout the development and manufacture process. This can be performed at the intact protein or subunit level and may involve identity, characterizing post-translational modifications (such as oxidation, glycosylation and PEGylation), impurity analysis, and oligomer characterization.

Application Notes

Application Notes

Protein therapeutics face stability and aggregation challenges as changes in amino acid sequence or chemical modifications can cause misfolding. High-throughput DLS enables rapid screening and stability studies, while SEC-MALS and SEC-MS offer detailed characterization in formulation development.

Protein therapeutics face stability and aggregation challenges as changes in amino acid sequence or chemical modifications can cause misfolding. High-throughput DLS enables rapid screening and stability studies, while SEC-MALS and SEC-MS offer detailed characterization in formulation development.

Application Notes

Application Notes

ultraDAWN real-time MALS directly monitors product attributes post-purification, enhancing yield and flexibility. It connects downstream purification and enrichment methods, such as IEX, FPLC, or TFF, to measure molecular weight, concentration, size, and impurities in real-time, streamlining processing and maximizing yield. 

ultraDAWN real-time MALS directly monitors product attributes post-purification, enhancing yield and flexibility. It connects downstream purification and enrichment methods, such as IEX, FPLC, or TFF, to measure molecular weight, concentration, size, and impurities in real-time, streamlining processing and maximizing yield. 

Application Notes

Application Notes

The efficacy of protein therapeutics greatly depends on the binding specificity and stability molecule. Light scattering techniques and calorimetry provide orthogonal methods that can narrow down candidates, optimized for both binding kinetics as well as stability.

The efficacy of protein therapeutics greatly depends on the binding specificity and stability molecule. Light scattering techniques and calorimetry provide orthogonal methods that can narrow down candidates, optimized for both binding kinetics as well as stability.

Application Notes

Webinar: SEC Column Selection and Care for Biotherapeutic Proteins and Peptides

Size exclusion chromatography (SEC) is commonly used throughout the research, development, and commercialization of biotherapeutic proteins and peptides. The key to successful SEC methods begins with selecting an appropriate SEC column, based on application need and LC instrumentation, and separation method to generate reliable quantitative data. Watch our webinar to learn how to select the right SEC column for your application and separation challenges.

Size exclusion chromatography (SEC) is commonly used throughout the research, development, and commercialization of biotherapeutic proteins and peptides. The key to successful SEC methods begins with selecting an appropriate SEC column, based on application need and LC instrumentation, and separation method to generate reliable quantitative data. Watch our webinar to learn how to select the right SEC column for your application and separation challenges.
Watch Webinar
Meet the people behind the quality products you use from Waters as they discuss the analytical challenges and opportunities facing scientists involved in established and trending applications.

Solutions

Enhance efficiency and accelerate sample throughput with system solutions tailored to labs conducting intact protein separation and analysis.

Enhance efficiency and accelerate sample throughput with system solutions tailored to labs conducting intact protein separation and analysis.

Routine biopharmaceutical analysis – accessible and accelerated

Routine biopharmaceutical analysis – accessible and accelerated
BioAccord LC-MS System

Achieve rapid and confident decisions driven by accessible, high-quality data with the BioAccord LC-MS System with ACQUITY Premier that is specifically designed for routine monitoring in biopharmaceutical process and product development.

  • Identity and Post-Translational Modification Analysis
  • Aggregation and Stability

Complete coverage for confident characterization

Complete coverage for confident characterization
Xevo G3 QTof

Maximize sample information for your analytes from detailed characterization to accurate quantitation with the Xevo G3 QTof, which enables complete confidence in your results – from challenging small molecules to complex biotherapeutics.

  • Identity and Post-Translational Modification Analysis
  • Aggregation and Stability

Ultimate flexibility for deeper discovery

Ultimate flexibility for deeper discovery
SYNAPT XS

Unlike competitor systems with restricted inlet options, scan function limitations, or requiring multiple platforms, only Waters offers an all-encompassing high-performing LC-MS solution, the SYNAPT XS mass spectrometer, for ultimate flexibility and greater freedom of analytical choice – supporting scientific creativity and technical success for any application.

  • Identity and Post-Translational Modification Analysis
  • Aggregation and Stability

Endless possibilities, limitless research

Endless possibilities, limitless research
SELECT SERIES Cyclic IMS

Developed through focused collaboration, the SELECT SERIES Cyclic IMS combines novel cyclic ion mobility separation with state-of-the-art, high performance, time-of-flight mass spectrometry, enabling leading researchers to unlock the potential in scientific discovery.

  • Identity and Post-Translational Modification Analysis
  • Aggregation and Stability

The universal platform for liquid chromatography

The universal platform for liquid chromatography
MaxPeak Premier Solutions

Eliminate the unpredictability of analyte losses due to metal interactions with MaxPeak Premier Solutions that combine state-of-the-art column and system technology for maximum sensitivity and reproducibility.

  • Identity and Post-Translational Modification Analysis
  • Aggregation and Stability
  • Real-Time Process Monitoring
  • Candidate Screening

Uniquely versatile detector for every development stage

Uniquely versatile detector for every development stage
DAWN Multi-angle Light Scattering Detector

Place downstream of any LC and perform advanced analysis of protein-complexes, post-translational modifications, and aggregation with the DAWN MALS Detector that assists at every development stage. Couple with Eclipe to measure binding affinity during discovery.

  • Candidate Screening
  • Chromatography
  • Identity and Post-Translational Modification Analysis
  • Aggregation and Stability

Measure size and zeta potential in native buffer

Measure size and zeta potential in native buffer
DynaPro ZetaStar

Combine DLS, SLS, and ELS all in one platform with the DynaPro ZetaStar instrument, specifically designed for biopharma to measure zeta-potential in formulation buffer without dilution.

  • Aggregation and Stability
  • Chromatography

High-throughput size and stability screening

High-throughput size and stability screening
DynaPro DLS Plate Reader

Measure size, polydispersity, and Tagg data for hundreds of samples with as little as 4 µL per well with the DynaPro DLS Plate Reader that uses standard-well plates and can integrate with any liquid handler to boost productivity further.

  • Candidate Screening
  • Aggregation and Stability

A process analytical technology breakthrough for nanoparticles, biopharmaceuticals, and polymers

A process analytical technology breakthrough for nanoparticles, biopharmaceuticals, and polymers
ultraDAWN Multi-angle Light Scattering Detector

Directly monitor titer, size, and impurities in real-time with ultraDAWN Multi-angle Light Scattering Detector that seamlessly connects downstream purification and enrichment methods, such as IEX, FPLC, or TFF.

  • Real-Time Process Monitoring

Compliance-ready, networkable applications-based software to streamline LC-MS data acquisition, processing, and reporting.

Compliance-ready, networkable applications-based software to streamline LC-MS data acquisition, processing, and reporting.

Streamline data analysis and processing

Streamline data analysis and processing
waters_connect for biopharmaceuticals

Accelerate the journey from sample analysis to decision-making with waters_connect for biopharmaceuticals that incorporates dedicated apps and workflows for intact mass analysis, sequence confirmation, multiple attribute monitoring, and more.

  • Identity and Post-Translational Modification Analysis
  • Aggregation and Stability

Achieve high efficiency separations for the analysis and purification of proteins including size-exclusion chromatography for aggregation, reversed-phase for intact and subunit, ion exchange for charge variants, and hydrophilic chromatography for glycoprotein analysis.

Achieve high efficiency separations for the analysis and purification of proteins including size-exclusion chromatography for aggregation, reversed-phase for intact and subunit, ion exchange for charge variants, and hydrophilic chromatography for glycoprotein analysis.

More confident biological compound separations start here

More confident biological compound separations start here
ACQUITY and XBridge Premier Protein SEC 250 Å Columns

Minimize secondary ionic or hydrophobic interactions in size-based separations with ACQUITY and XBridge Premier Protein SEC 250 Å Columns with MaxPeak High Performance Surface (HPS) Technology for reliable protein aggregate, monomer, and fragment analyses using a “platform” type method with 30% increase in resolution.

  • Identity and Post-Translational Modification Analysis
  • Aggregation and Stability
  • Real-Time Process Monitoring
  • Candidate Screening

Innovative solutions for mAb characterizations for charge variant and intact and subunit analyses

Innovative solutions for mAb characterizations for charge variant and intact and subunit analyses
BioResolve Columns and Consumables

BioResolve RP mAb Polyphenyl  Columns provide improved peak capacity and minimal carry-over for intact and subunit analysis of proteins and mAbs specifically QC-tested with a NIST-based, mAb subunit standard. BioResolve SCX mAb Columns and Buffers reliably separate charge variants for a wide range of mAbs using optical or LC-MS compatible mobile phases.

  • Identity and Post-Translational Modification Analysis
  • Aggregation and Stability
  • Real-Time Process Monitoring
  • Candidate Screening

Uniquely selective for optimal glycosylation profile analysis

Uniquely selective for optimal glycosylation profile analysis
ACQUITY Premier Glycan Columns

Obtain glycan occupancy and glycoprotein profiles from intact proteins with a wide-pore, HILIC stationary phase for unique selectivity with the ACQUITY Premier Glycoprotein BEH Amide 300 Å Column. 

  • Identity and Post-Translational Modification Analysis
  • Real-Time Process Monitoring
  • Candidate Screening

Fast, reproducible results for bioprocessing, drug discovery, and drug development applications

Fast, reproducible results for bioprocessing, drug discovery, and drug development applications
High Throughput Columns

Accelerate your drug development with short, high throughput columns and obtain size-exclusion chromatography in less than 2 minutes, glycoforms in 3 minutes, charge variants and subunit analysis in less than 4 minutes. In addition to faster analyses, high throughput columns can reduce solvent consumption up to 80% (for BioResolve Premier RP mAb Polyphenyl Column). 

  • Identity and Post-Translational Modification Analysis
  • Real-Time Process Monitoring
  • Candidate Screening

Benchmark and validate intact and subunit LC analysis 

Benchmark and validate intact and subunit LC analysis 
Protein Standards and Kits

Gain efficiency and quality with Waters variety of ISO certified, manufactured, and QC-tested standards for recommended columns to help confirm desired batch to batch, column to column, and instrument performance prior to testing valuable samples.

  • Identity and Post-Translational Modification Analysis
  • Aggregation and Stability
  • Real-Time Process Monitoring
  • Candidate Screening

Gain efficiency and walk away time with verified lab automation solutions.

Gain efficiency and walk away time with verified lab automation solutions.

Enhance sample prep efficiency and throughput.

Enhance sample prep efficiency and throughput.
Laboratory Automation and Equipment

Streamline sample preparation for quantitative LC-MS analyses with verified workflows that help minimize variability, improve traceability, and simplify method transfer.

  • Identity and Post-Translational Modification Analysis
  • Aggregation and Stability
  • Candidate Screening
  • Real-Time Process Monitoring

Your success is just a click away

Your success is just a click away
Waters Global Services

Optimize your laboratory's productivity and success with Waters Global Services to maintain peak system performance, minimize down time, address application challenges, and support stringent compliance requirements.

  • Identity and Post-Translational Modification Analysis
  • Aggregation and Stability
  • Candidate Screening
  • Real-Time Process Monitoring

Make science more accessible with Waters Capital

Make science more accessible with Waters Capital
Payment Solutions

Maximize resources and minimize risk with payment options from Waters Capital, including upgrading aging equipment, getting customized support, and bundling services into one monthly payment.

  • Identity and Post-Translational Modification Analysis
  • Aggregation and Stability
  • Candidate Screening
  • Real-Time Process Monitoring

The data speaks for itself

The data speaks for itself
Analysis of NISTmAb reference material 8671 on the XBridge Premier Protein SEC 250 Å and the competitive silica dSEC-2 column Isocratic separation performed using a mobile phase of 2x PBS in water, flow rate of 0.57 mL/min, and UV detection at 280 nm.
Using the UPLC Intact Mass Analysis Kit, rapid gradient cycles were applied to regenerate the column to pre-injection conditions as part of the analysis of an intact antibody. The total ion chromatogram (TIC) shows no detectable carryover following a 0.5 µg injection. Thus, the need to use inter-run blank injections with difficult samples is eliminated. 
Peptide mapping analysis of trastuzumab fractions. (A) Trastuzumab fractions collected from a BioResolve SCX mAb, 4.6 × 100 mm Column. (B) Mirror image of peptide maps for Fractions 5 and 7. A peak at a retention time of 30.24 min increased significantly in Fraction 5, compared to that in Fraction 7 (indicated by the blue arrow). (C) Extracted ion chromatograms (XIC) for identified peptides. The peak at 30.26 min has been identified as deamidation of the peptide ASQDVNTAVAWYQQKPGK. The un-modified peak has a retention time of 29.63 min. (D) MS-MS fragment comparison of the deamidated and un-modified peptide ASQDVNTAVAWYQQKPGK. The fragments that do not contain asparagine have the same mass value, while the fragments that do contain asparagine differ in 1 Da in mass.
Combined MS spectra, zoom, and corresponding MaxEnt1 deconvoluted masses of trastuzumab using different IDC counts.
Separation of mAb Subunit Standard using 1-minute and 4-minute gradient on a 20 mm column, as well as 20-min gradient on a 100 mm column. Comparable combined spectra of the three main peaks and the deconvoluted mass (insert) were obtained.
Comparison of LC-MS separation of the mAb Subunit Standard on a 2.1 x 20 mm BioResolve Premier RP mAb Polyphenyl 450 Å 2.7 µm Column (4-minute gradient) and a 2.1 x 100 mm BioResolve RP mAb Polyphenyl 450 Å 2.7 µm Column (20-minute gradient).

Webinars and Resources

  • Application Notebook

A Focus on Protein Therapeutics

A Focus on Protein Therapeutics
Download
  • eBook

Improving Chromatographic Separations of Biopharmaceuticals with MaxPeak High Performance Surfaces (HPS) Technology

Improving Chromatographic Separations of Biopharmaceuticals with MaxPeak High Performance Surfaces (HPS) Technology
Download

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Learn more about Intact and Subunit Protein Analysis Solutions.

Learn more about Intact and Subunit Protein Analysis Solutions.
Intact Protein Analysis
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