--- title: BioPharmaceutical Characterization Resource Center - Aggregate Analysis --- [Chromatography Forum](http://www.chromforum.org/) [Analytical Training Solutions](https://www.analytical-training-solutions.com) [日本語](https://www.sepscience.com/japan) [![Separation Science](https://learning.sepscience.com/hubfs/Sepscience_Dec2016/images/-resized-strch-SepSci_WebHeader_v3.png)](https://www.sepscience.com/) [Chromatography Forum](http://www.chromforum.org/) [Analytical Training Solutions](https://www.analytical-training-solutions.com) [日本語](https://blog.sepscience.com/japan) [Sign Up for Newsletter](https://www.sepscience.com/subscribe/) ![HeaderImage_v2](https://learning.sepscience.com/hs-fs/hubfs/HeaderImage_v2.png?width=1280&name=HeaderImage_v2.png)  [![Home](https://learning.sepscience.com/hs-fs/hubfs/Companies/Thermo%20Fisher%20Scientific/BioPMicrosite/Home.png?width=47&name=Home.png)](https://learning.sepscience.com/biopharmaceutical-characterization-resource-center-home)  [![PeptideMapping](https://learning.sepscience.com/hs-fs/hubfs/Companies/Thermo%20Fisher%20Scientific/BioPMicrosite/PeptideMapping.png?width=118&name=PeptideMapping.png)](https://learning.sepscience.com/biopharmaceutical-characterization-resource-center-peptide-mapping)  [![LabelledGlycan](https://learning.sepscience.com/hs-fs/hubfs/Companies/Thermo%20Fisher%20Scientific/BioPMicrosite/LabelledGlycan.png?width=158&name=LabelledGlycan.png)](https://learning.sepscience.com/biopharmaceutical-characterization-resource-center-labelled-glycans)  [![UnlabelledGlycan](https://learning.sepscience.com/hs-fs/hubfs/Companies/Thermo%20Fisher%20Scientific/BioPMicrosite/UnlabelledGlycan.png?width=189&name=UnlabelledGlycan.png)](https://learning.sepscience.com/biopharmaceutical-characterization-resource-center-unlabelled-glycan)  [![NativeMass](https://learning.sepscience.com/hs-fs/hubfs/Companies/Thermo%20Fisher%20Scientific/BioPMicrosite/NativeMass.png?width=142&name=NativeMass.png)](https://learning.sepscience.com/biopharmaceutical-characterization-resource-center-native-mass-analysis)  [![AggregateAnalysis](https://learning.sepscience.com/hs-fs/hubfs/Companies/Thermo%20Fisher%20Scientific/BioPMicrosite/AggregateAnalysis.png?width=126&name=AggregateAnalysis.png)](https://learning.sepscience.com/biopharmaceutical-characterization-resource-center-aggregate-analysis)  [![ChargeVariantAnalysis](https://learning.sepscience.com/hs-fs/hubfs/Companies/Thermo%20Fisher%20Scientific/BioPMicrosite/ChargeVariantAnalysis.png?width=158&name=ChargeVariantAnalysis.png)](https://learning.sepscience.com/biopharmaceutical-characterization-resource-center-charge-variant-analysis) ## Aggregate Analysis Aggregation of therapeutic proteins can result in an incorrect drug dosage, or an undesired and potentially fatal immune response. Consequently, monitoring protein aggregates is important for safety and quality assurance. Investigators routinely use size-exclusion chromatography (SEC), which separates particles according to hydrodynamic size. Recently the use of hydrophobic interaction chromatography (HIC) has also received great interest as an orthogonal technique to SEC. HIC separates proteins based on the hydrophobicity in the native state and can often detect changes in protein structure as well as aggregates. ### Improve Your Protein Aggregate Analysis   Therapeutic protein aggregate species can trigger dangerous immunotoxic responses in patients. Confident, fast detection of aggregates is critical for drug product quality. This can be delivered with the Thermo Scientific Protein Aggregate workflow.   ### The Importance of Correct UHPLC Instrument Setup for Protein Aggregate Analysis by Size-exclusion Chromatography   The goal of this study was to show the applicability of Thermo Scientific™ MabPac™ SEC-1 columns for monoclonal antibody aggregate analysis using the Thermo Scientific™ Vanquish™ Flex Quaternary UHPLC system. [![Read the application note >>](https://no-cache.hubspot.com/cta/default/2322077/7a8d9b42-0a6b-40a5-a97c-8f9dcae56447.png)](https://cta-redirect.hubspot.com/cta/redirect/2322077/7a8d9b42-0a6b-40a5-a97c-8f9dcae56447)     ### A Universal Chromatography Method for Aggregate Analysis of Monoclonal Antibodies   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 aims of this study were to produce a single globally applicable SEC chromatography method for the five mAb samples, show peak symmetry (implying limited secondary interaction with the column), and maintain the required monomer and dimer. resolution. [![Read the application note >>](https://no-cache.hubspot.com/cta/default/2322077/7ddf5f8e-cb1b-4368-b801-4a833149089e.png)](https://cta-redirect.hubspot.com/cta/redirect/2322077/7ddf5f8e-cb1b-4368-b801-4a833149089e)     ### \[eBook\] Methods & Applications in BioPharmaceutical Characterization ![Thermo_Biop_eBookCover_eDM](https://learning.sepscience.com/hs-fs/hubfs/Companies/Thermo%20Fisher%20Scientific/BioPMicrosite/eBook/Thermo_Biop_eBookCover_eDM.png?width=120&name=Thermo_Biop_eBookCover_eDM.png)Read about... - Intact Protein Analysis - Monoclonal Subunit Mass Analysis - Peptide Mapping Analysis - Peptide Mapping - Labeled Glycan Analysis - Unlabeled Glycan Analysis - Aggregate Analysis - Charge Variant Analysis [![Read >>](https://no-cache.hubspot.com/cta/default/2322077/18bbdd63-2155-44ff-875b-1203f6eab768.png)](https://cta-redirect.hubspot.com/cta/redirect/2322077/18bbdd63-2155-44ff-875b-1203f6eab768)     ### High-throughput protein aggregate analysis of monoclonal antibodies using a novel dual-channel UHPLC instrument ![High-throughput protein aggregate analysis of monoclonal antibodies using a novel dual-channel UHPLC instrument](https://learning.sepscience.com/hs-fs/hubfs/Companies/Thermo%20Fisher%20Scientific/BioPMicrosite/AppNote4_AG.png?width=100&name=AppNote4_AG.png)To demonstrate the high-throughput capabilities of the newly developed Thermo Scientific™ Vanquish™ Flex Duo UHPLC system for Dual LC. This study focused on data reproducibility and the quality of chromatography, while comparing technology performance to the standard Thermo Scientific™ Vanquish™ Flex Quaternary UHPLC system. [![Read >>](https://no-cache.hubspot.com/cta/default/2322077/4db4f3d9-3996-4344-a293-cf3ad607bd5c.png)](https://cta-redirect.hubspot.com/cta/redirect/2322077/4db4f3d9-3996-4344-a293-cf3ad607bd5c)     ### HIC as a Complementary, Confirmatory Tool to SEC for the Analysis of mAb Aggregates ![HIC as a Complementary, Confirmatory Tool to SEC for the Analysis of mAb Aggregates](https://learning.sepscience.com/hs-fs/hubfs/Companies/Thermo%20Fisher%20Scientific/BioPMicrosite/AppNote5_AG.png?width=100&name=AppNote5_AG.png)To demonstrate the analysis of monoclonal antibody (mAb) aggregates using the Thermo Scientific™ MAbPac™ SEC-1 and MAbPac™ HIC-10 columns. The MAbPac SEC-1 column provides fast and high-resolution separation of mAb aggregates from the monomer. The MAbPac HIC-10 column provides excellent separation of mAb aggregates from the monomer and the ability to resolve mAb variants. [![Read >>](https://no-cache.hubspot.com/cta/default/2322077/12e2c23e-8ff5-40b0-bd26-0bdcee71fc79.png)](https://cta-redirect.hubspot.com/cta/redirect/2322077/12e2c23e-8ff5-40b0-bd26-0bdcee71fc79)     ### Lifetime stability of size exclusion chromatography columns for protein aggregate analysis ![Lifetime stability of size exclusion chromatography columns for protein aggregate analysis](https://learning.sepscience.com/hs-fs/hubfs/Companies/Thermo%20Fisher%20Scientific/BioPMicrosite/AppNote3_AG.png?width=100&name=AppNote3_AG.png)The aim of this work was to demonstrate the long-term stability of the Thermo Scientific™ MAbPac™ SEC-1 column for monoclonal antibody aggregate analysis using the Thermo Scientific™ Vanquish™ Flex Quaternary UHPLC system. [![Read >>](https://no-cache.hubspot.com/cta/default/2322077/4e55f3de-ef95-4944-b87f-2b090474dbab.png)](https://cta-redirect.hubspot.com/cta/redirect/2322077/4e55f3de-ef95-4944-b87f-2b090474dbab)       [![CONTACT ME Would you like a demo, quote or to speak to a Thermo Fisher Scientific sales professional about the technologies on this page?](https://no-cache.hubspot.com/cta/default/2322077/66e68182-d00b-484f-9668-baecd75415ba.png)](https://cta-redirect.hubspot.com/cta/redirect/2322077/66e68182-d00b-484f-9668-baecd75415ba) Eclipse Business Media Ltd, Regd in England, No. 06513189, Woodview, Bull Lane Industrial Estate, Sudbury, CO10 0FD, United Kingdom, T +44 (0)161 818 7434, [info@sepscience.com](mailto:info@sepscience.com)   Eclipse Business Media Ltd needs the contact information you provide to us to contact you about our products and services. You may unsubscribe from these communications at any time. 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