CE-SDS

CE-SDS (Capillary Electrophoresis-Sodium Dodecyl Sulfate) is an automated laboratory method used for the precise size-based separation of large biological products like monoclonal antibodies. By coating molecules with SDS detergent and passing them through a capillary tube via electric current, it generates a digital profile of intact molecules, fragments, and aggregates.

CE-SDS verifies safety and regulatory compliance

CE-SDS is a vital component of lab reports used to verify safety and ensure regulatory compliance for biological products. It is particularly important for detecting high aggregate levels that could trigger adverse immune reactions. Laboratories usually perform this test in two ways: non-reduced to keep molecules intact, or reduced to break bonds and check individual protein chains.

CE-SDS is distinct from SDS-PAGE and HPLC methods

• SDS-PAGE: CE-SDS serves as the modern, automated successor to this older manual gel testing method.
• SE-HPLC: Compared to SE-HPLC, which relies on physical filters, CE-SDS uses detergents to achieve more precise fragment quantification.
• RP-HPLC: While RP-HPLC separates by chemical properties, CE-SDS separates by size and is generally preferred for large molecules rather than small synthetic peptides.

Sources

1. Interlaboratory method validation of capillary electrophoresis sodium dodecyl sulfate (CE-SDS) methodology for analysis of mAbs - PubMed
2. Specific and high-resolution identification of monoclonal antibody fragments detected by capillary electrophoresis–sodium dodecyl sulfate using reversed-phase HPLC with top-down mass spectrometry analysis - PMC
3. HPLC Analysis and Purification of Peptides - PMC
4. Characterization and elimination of artificial non-covalent light Chain dimers in reduced CE-SDS analysis of pertuzumab - PubMed
5. ICH Q6B Specifications: test procedures and acceptance criteria for biotechnological/biological products - Scientific guideline | European Medicines Agency (EMA)
6. Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products | FDA
7. Guidance for Industry Q6B Specifications: Test Procedures
8. Identification of a CE-SDS shoulder peak as disulfide-linked ... - PMC
9. Monitoring of low-molecular-weight protein aggregation by CE-SDS as a complementary method to SE-HPLC - PubMed
10. A comparative study of CE-SDS, SDS-PAGE, and Simple Western: Influences of sample preparation on molecular weight determination of proteins - PubMed
11. Recent Trends of Capillary Electrophoresis-Mass Spectrometry in Proteomics Research
12. A Comprehensive Review on Capillary Electrophoresis–Mass Spectrometry in Advancing Biomolecular Research
13. Protein Separation by Capillary Gel Electrophoresis: A Review
14. Using capillary electrophoresis sodium dodecyl sulfate (CE-SDS) and liquid chromatograph mass spectrometry (LC-MS) to identify glycosylated heavy chain heterogeneity in the anti-VEGFR-2 monoclonal antibody - PubMed
15. [PDF] Capillary Electrophoresis in Quality Control PART II: CE-SDS - SCIEX
16. Capillary Electrophoresis in Quality Control: Part I
17. Comparing SDS-PAGE and CE-SDS for Antibody Purity Analysis
18. What Is the Principle of Capillary Electrophoresis Purity Analysis (CE-SDS)? What Are the Functions of the Reagents Used | MtoZ Biolabs