Intact Protein Analysis Made Simple

Reproducible Intact Protein Analysis: The Right Technology for Your Lab

Intact biotherapeutic analysis is used throughout the product development life cycle to ensure both the proper selection of lead candidates and reproducible product quality. However intact protein characterization of diverse and complex biotherapeutics can be extremely challenging, presenting several analytical performance issues.

SCIEX offers a range of technology solutions specifically designed to address the analytical challenges of intact protein analysis, from candidate selection to post-commercialization. Our innovative LC-MS, CESI-MS and capillary electrophoresis (CE) technologies consistently deliver fast, accurate and reproducible assays and easy to interpret analysis for diverse and complex biotherapeutics.

Solving the Challenges

Your increasing workload means you need highly reproducible intact protein data at your fingertips. SCIEX offers multiple approaches that enable you to routinely analyze even the most complex biotherapeutics throughout the development life cycle. Our powerful LC-MS, CESI-MS and CE technologies provide you with high quality, highly reproducible intact protein characterization data, faster and more efficiently than you thought possible.

Simplified and Accelerated Accurate Mass Analysis by LC-MS

Intact mass and subunit analysis by LC-MS provides confirmation of therapeutic mass and high-level heterogeneity. You can accelerate your routine intact and subunit biologic protein workflows with the ultra-compact and user friendly X500B QTOF System, designed specifically for biologics and with LC-MS novices in mind. Its simple point-and-click interface makes data acquisition and processing within reach for every operator, regardless of their level of experience. High quality data with good reproducibility means you can confidently determine the accurate mass of your protein isoforms, faster and easier than before.

Enhance Your View With CESI-MS

CESI-MS provides orthogonal separation when compared to traditional LC approaches, delivering a more thorough characterization of complex intact biologic products. SCIEX CESI-MS solutions reduce the complexity of analysis compared to standalone LC, which requires fractionation and MS detection.

Fast, Confident Characterization by CE

Capillary electrophoresis (CE) intact protein assays provide information on purity, identity and charge heterogeneity of your intact biotherapeutics. SCIEX CE is the tried and tested platform with proven assay portability for routine intact protein analysis. Advanced temperature controlled capillary technology results in the most robust and reproducible analyses. The software interface is simple and visual and intuitive, not requiring expertise to run in routine fashion.

“…characterization of biomolecules by CE is a robust technology when the method is well described and controlled. This exercise supports and endorses the increased application of CE methodology within both development and QC laboratories within biopharmaceutical companies.” - Intercompany collaboration on CE-SDS: A Series of Collaborations Between Various Pharmaceutical Companies and Regulatory Authorities Concerning the Analysis of Biomolecules Using Capillary Electrophoresis, Chromatographia 2006, 64, 359–368, B. Nunnally et al.

See how easy the Intact Mass Analysis workflow is with this Interactive Demo

Robust and Reproducible Solutions for Intact Characterization

Intact protein analysis is required throughout the drug development pipeline from clone selection to post-commercialization. Whether you need to confirm your protein mass, analyze protein charge variants or execute routine standardized assays in a compliant environment, SCIEX has a tailored solution to meet your needs.

Simple and Streamlined LC-MS

For labs needing to do routine mass confirmation and molecular heterogeneity analysis, the X500B QTOF System offers an easy-to-use platform accessible to mass spec users with varying levels of experience.

ExionLC™ AD System

Delivers high-accuracy, reliability and repeatability across thousands of injections, with maximum uptime

X500B QTOF System

Accurate mass analysis with the compact and streamlined QTOF System and the renowned Turbo V™ ionization source

SCIEX OS Interface

Intuitive point-and-click acquisition software makes it easier than ever to set-up and run your methods

BioPharmaView™ Software

Automated biotherapeutic data processing for accurate mass determination and automated calculation of glycoprotein ratios

Biologics LC-MS Training

Get up and running quickly with access to our online training programs specifically for biotherapeutic characterization

Intact Biotherapeutic Mass Analysis

Intact Biotherapeutic Mass Analysis

Technical Note

Intact Analysis of Antibody Drug Conjugates

Method Flyer

Intact Biotherapeutic Mass Analysis

Technical Note

Routine Workflow for Comparability assessment of Protein Biopharmaceuticals

Method Flyer

Intact Antibody Drug Conjugate (ADC) Analysis

Product Bulletin

BioPharmaView™ Software 2.0

Video

X500B QTOF System Overview

Video

BioPharmaView™ Software Overview

Webinar

Enabling the Use of Mass Spectrometry throughout Biopharmaceutical Development

Method Flyer

Biotherapeutic Subunit Mass Analysis

Technical Note

Comparative Multi-Supplier Lot Analysis of Trastuzumab using Subunit Analysis on the X500B QTOF System

Solutions Guide

Innovation for Biotherapeutic Comparability with BioPharmaView™ Software

In-Depth Characterization by CESI-MS

For labs needing to gain accurate mass information on biotherapeutics, CESI-MS offers a highly sensitive workflow that streamlines orthogonal charge variant analyses. This is particularly important for samples with limited volumes, or if you are working with toxic molecules such as antibody drug conjugates.

CESI 8000 Plus

Achieve enhanced protein isoform separation and improve protein ionization with integrated capillary electrophoresis and electrospray ionization coupled with mass spectrometry (CESI-MS). The CESI 8000 Plus can also function as a standalone CE analyzer

TripleTOF® 6600

Confidently identify low abundance protein isoforms with this high-sensitivity accurate mass system with wide linear dynamic range of detection

BioPharmaView™ Software

Delivers automated biotherapeutic data processing for accurate mass determination and automated calculation of glycoprotein ratios

Video

Intact Proteoform Characterization using CESI-MS

Technical Note

A New Approach to The Analysis of Intact Mups (Major Urinary Proteins) From Mice By CESI-MS

Video

CESI-MS for Multilevel Characterization of Protein Therapeutics

Technical Note

Structural Characterization of Antibody Drug Conjugates (ADCs) By Intact, Middle-up and Bottom-up Approaches Using CESI-MS

Gold Standard Capillary Electrophoresis

For labs doing regulated, intact biotherapeutic characterization in analytical development or in a compliant QA/QC environment, SCIEX CE solutions offer the most complete end-to-end offering. Our solutions included comprehensive sample preparation chemistry kits, innovative hardware, powerful processing software and world-class support.

Validated Chemistry Kits

All reagents, capillaries and protocols necessary to perform intact biotherapeutic analysis are available in these validated chemistry kits

PA 800 Plus

Achieve maximal reproducibility in biotherapeutic assays with this industry and regulatory proven technology with temperature controlled capillary technology

PA 800 Plus Software

The intuitive and visual PA 800 Plus Software makes set-up fast and straightforward

Publication

Intercompany Study to Evaluate the Robustness of Capillary Isoelectric Focusing Technology for the Analysis of mAbs.

Publication

Evaluation of capillary zone electrophoresis for charge heterogeneity testing of monoclonal antibodies.

Learning Center  
Solutions Guide: Biotherapeutic Intact Mass Analysis Download
Method Flyer: Intact Biotherapeutic Mass Analysis Download
Solutions Guide: Biotherapeutic Comparability Download
Tech Note: Intact Analysis of Antibody Drug Conjugates Download
Tech Note: Routine Workflow for Comparability assessment of Protein Biopharmaceuticals Download
Tech Note: Comparative Multi-Supplier Lot Analysis of Trastuzumab using Subunit Analysis on the X500B QTOF System Download
Tech Note: A New Approach to The Analysis of Intact Mups (Major Urinary Proteins) From Mice By CESI-MS Download
Tech Note: Structural Characterization of Antibody Drug Conjugates (ADCs) By a Combination of Intact, Middle-up and Bottom-up Approaches Using CESI-MS Download
Product Bulletin: BioPharmaView™ Software 2.0 Download
Webinar: Enabling the Use of Mass Spectrometry throughout Biopharmaceutical Development Watch
Video: X500B QTOF System Watch
Video: BioPharmaView™ Software Overview Watch
Video: Intact Proteoform Characterization using CESI-MS Watch
Video: CESI-MS for Multilevel Characterization of Protein Therapeutics Watch
Method Flyer: Intact Antibody Drug Conjugate (ADC) Analysis Download
Method Flyer: Biotherapeutic Subunit Mass Analysis Download
A Series of Collaborations Between Various Pharmaceutical Companies and Regulatory Authorities Concerning the Analysis of Biomolecules Using Capillary Electrophoresis Download