September 2012 Subscribe Go to Application Note Library Analysis of Monoclonal Antibody Charge Variants by Capillary Zone Electrophoresis Marcia R. Santos, Beckman Coulter Life Sciences A high-speed strategy to assess charge heterogeneity of IgG molecules by CE. Described here are sample preparation, separation method set-up, and a detailed analysis of separation data.   Separation of Recombinant Human Erythropoietin (rhEPO) Using the European Pharmacopoeia Method on the PA 800 plus Pharmaceutical Analysis System Marcia R. Santos, Beckman Coulter Life Sciences Described here is the separation of erythropoietin (EPO) using an existing European Pharmacopeia CE method. Sample preparation and system configuration are described in detail. Additionally, representative data is presented for both sample analysis and system suitability.   High-Resolution cIEF of Therapeutic Monoclonal Antibodies: A Platform Method Covering pH 4–10 Scott Mack, Ingrid D. Cruzado-Park, and Chitra K. Ratnayake, Beckman Coulter Life Sciences This bulletin describes the development of a platform cIEF method for characterization of IgG charge heterogeneity. Detailed system set-up and data analysis illustrating assay robustness are included.   Separation of Fucosylated, Non-Fucosylated, and Complex Carbohydrates Associated with mAB Using CE Sushma Rampal, Beckman Coulter Life Sciences, Lynn Gennaro, Genentech - Roche in San Francisco, CA, and Mark Lies, Beckman Coulter Life Sciences Described is the application of CE for separation of N-linked oligosaccharides commonly associated with monoclonal antibodies. The high resolution, automated, quantitative nature of CE allows for easy separation of these complex glycan populations.   Assay of IgG Purity and Heterogeneity Using High-Resolution Sodium Dodecyl Sulfate Capillary Gel Electrophoresis Lucy Y. Liu, Chitra Ratnayake, Jeff Chapman, Narasaiah Dontha, Sae Choo, and M. P. Reddy, Beckman Coulter Life Sciences Described here is the application of CE technology as a replacement for SDS-PAGE in purity assessment of IgG molecules. Also included is a discussion on key assay characteristics including reproducibility and precision.   Capillary Electrophoresis in Quality Control, Part II: CE-SDS: Method Development and Robustness Chantal Felten, Alpine Analytical in Whistler, British Columbia, and Oscar Salas Solano, Seattle Genetics, Bothell, WA This document illustrates the application of CE-SDS for quality control processes. Included is a discussion on method purpose, method preparation, and critical robustness of the CE-SDS assay as it pertains to quality control of biologics. Automated Cord Blood Cell Viability and Concentration Measurements Using the Vi-CELL™ XR Stephen E. Szabo and Sarah Monroe, Beckman Coulter Life Sciences This bulletin describes preparation techniques and special considerations for performing viability measurements on umbilical cord blood.   Use of Beckman Coulter Reagents for Automated, Whole Blood, White Blood Cell Viability Measurements Stephen E. Szabo and Sarah Monroe, Beckman Coulter Life Sciences Described here is the measurement of red and white blood cell concentration and viability.   Stem Cell Analyses Using the Vi-CELL XR Stephen E. Szabo and Sarah Monroe, Beckman Coulter Life Sciences Special considerations for analyzing larger populations of stem cells are presented here. Key Factors for Detecting Particles in Protein Formulations Using the Coulter Principle Detailed in AAPS Journal Matthew N. Rhyner, Beckman Coulter Life Sciences Here we describe the best techniques for counting and sizing protein aggregates below one micron in size. Techniques are also applicable to very small particles.