The SCIEX clinical diagnostic portfolio is For In Vitro Diagnostic Use. Rx Only. Product(s) not available in all countries. For information on availability, please contact your local sales representative or refer to https://sciex.com/diagnostics. All other products are For Research Use Only. Not for use in Diagnostic Procedures.
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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.
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.
“…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.
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.
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.
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.
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.
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.
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
Confidently identify low abundance protein isoforms with this high-sensitivity accurate mass system with wide linear dynamic range of detection
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.
All reagents, capillaries and protocols necessary to perform intact biotherapeutic analysis are available in these validated chemistry kits
Achieve maximal reproducibility in biotherapeutic assays with this industry and regulatory proven technology with temperature controlled capillary technology
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.
Delivers high-accuracy, reliability and repeatability across thousands of injections, with maximum uptime
Accurate mass analysis with the compact and streamlined QTOF System and the renowned Turbo V™ ionization source
Intuitive point-and-click acquisition software makes it easier than ever to set-up and run your methods
Automated biotherapeutic data processing for accurate mass determination and automated calculation of glycoprotein ratios
Solutions Guide: Biotherapeutic Intact Mass Analysis
Method Flyer: Intact Biotherapeutic Mass Analysis
Solutions Guide: Biotherapeutic Comparability
Tech Note: Intact Analysis of Antibody Drug Conjugates
Tech Note: Routine Workflow for Comparability assessment of Protein Biopharmaceuticals
Tech Note: Comparative Multi-Supplier Lot Analysis of Trastuzumab using Subunit Analysis on the X500B QTOF System
Tech Note: A New Approach to The Analysis of Intact Mups (Major Urinary Proteins) From Mice By CESI-MS
Tech Note: Structural Characterization of Antibody Drug Conjugates (ADCs) By a Combination of Intact, Middle-up and Bottom-up Approaches Using CESI-MS
Product Bulletin: BioPharmaView™ Software 2.0
Webinar: Enabling the Use of Mass Spectrometry throughout Biopharmaceutical Development
Video: X500B QTOF System
Video: BioPharmaView™ Software Overview
Video: Intact Proteoform Characterization using CESI-MS
Video: CESI-MS for Multilevel Characterization of Protein Therapeutics
Method Flyer: Intact Antibody Drug Conjugate (ADC) Analysis
Method Flyer: Biotherapeutic Subunit Mass Analysis
A Series of Collaborations Between Various Pharmaceutical Companies and Regulatory Authorities Concerning the Analysis of Biomolecules Using Capillary Electrophoresis
For research use only. Not for use in diagnostic procedures.
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