Qualification of NISTmAb charge heterogeneity control assays

The NISTmAb Reference Material 8671 lifecycle management and quality plan

(2018) John E. Schiel et al.   ANALYTICAL AND BIOANALYTICAL CHEMISTRY

The NISTmAb Reference Material 8671 value assignment, homogeneity, and stability

(2018) John E. Schiel et al.   ANALYTICAL AND BIOANALYTICAL CHEMISTRY

Isolation and Characterization of Monoclonal Antibody Charge Variants by Free Flow Isoelectric Focusing

(2016) Brian D. Hosken et al.   ANALYTICAL CHEMISTRY

Cutting-edge capillary electrophoresis characterization of monoclonal antibodies and related products

(2016) Rabah Gahoual et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

In-Depth Characterization and Spectral Library Building of Glycopeptides in the Tryptic Digest of a Monoclonal Antibody Using 1D and 2D LC–MS/MS

(2016) Qian Dong et al.   JOURNAL OF PROTEOME RESEARCH

Enhanced Detection of Low-Abundance Host Cell Protein Impurities in High-Purity Monoclonal Antibodies Down to 1 ppm Using Ion Mobility Mass Spectrometry Coupled with Multidimensional Liquid Chromatography

(2015) Catalin E. Doneanu et al.   ANALYTICAL CHEMISTRY

Capillary ion-exchange chromatography with nanogram sensitivity for the analysis of monoclonal antibodies

(2015) Jennifer C. Rea et al.   JOURNAL OF CHROMATOGRAPHY A

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

(2015) Bernd Moritz et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Method development for the separation of monoclonal antibody charge variants in cation exchange chromatography, Part I: Salt gradient approach

(2015) Szabolcs Fekete et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Capillary isoelectric focusing method development and validation for investigation of recombinant therapeutic monoclonal antibody

(2015) Dávid Suba et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Method development for the separation of monoclonal antibody charge variants in cation exchange chromatography, Part II: pH gradient approach

(2015) Szabolcs Fekete et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

2D 1HN, 15N Correlated NMR Methods at Natural Abundance for Obtaining Structural Maps and Statistical Comparability of Monoclonal Antibodies

(2015) Luke W. Arbogast et al.   PHARMACEUTICAL RESEARCH

Characterization of Therapeutic Antibodies and Related Products

(2012) Alain Beck et al.   ANALYTICAL CHEMISTRY

Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars

(2012) Steven A. Berkowitz et al.   NATURE REVIEWS DRUG DISCOVERY

Capillary electrophoresis and isoelectric focusing in peptide and protein analysis

(2012) Pier Giorgio Righetti et al.   PROTEOMICS

Rapid analysis of charge variants of monoclonal antibodies with capillary zone electrophoresis in dynamically coated fused-silica capillary

(2011) Yan He et al.   JOURNAL OF SEPARATION SCIENCE

Worldwide experience with biosimilar development

(2011) Mark McCamish et al.   mAbs

A systematic study in CIEF: Defining and optimizing experimental parameters critical to method reproducibility and robustness

(2009) Scott Mack et al.   ELECTROPHORESIS

Application of imaging capillary IEF for characterization and quantitative analysis of recombinant protein charge heterogeneity

(2008) Zoran Sosic et al.   ELECTROPHORESIS