A novel method for continuous chromatographic separation of monoclonal antibody charge variants by combining displacement mode chromatography and step elution

Complete or periodic continuity in continuous manufacturing platforms for production of monoclonal antibodies?

(2021) Nikhil Kateja et al.   Biotechnology Journal

A novel twin‐column continuous chromatography approach for separation and enrichment of monoclonal antibody charge variants

(2021) Shu‐Ying Jing et al.   ENGINEERING IN LIFE SCIENCES

Using continuous chromatography methodology to achieve high-productivity and high-purity enrichment of charge variants for analytical characterization

(2021) Elizabeth Bigelow et al.   JOURNAL OF CHROMATOGRAPHY A

Identification of monoclonal antibody variants involved in aggregate formation – Part 1: Charge variants

(2020) Robina M. Meyer et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Separation of monoclonal antibody charge variants using cation exchange chromatography: Resins and separation conditions optimization

(2019) Shu-Ying Jing et al.   SEPARATION AND PURIFICATION TECHNOLOGY

Evaluation of differences between dual salt-pH gradient elution and mono gradient elution using a thermodynamic model: Simultaneous separation of six monoclonal antibody charge and size variants on preparative-scale ion exchange chromatographic resin

(2018) Yi Feng Lee et al.   BIOTECHNOLOGY PROGRESS

Rapid preparative separation of monoclonal antibody charge variants using laterally-fed membrane chromatography

(2018) Rahul Sadavarte et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

How Similar Is Biosimilar? A Comparison of Infliximab Therapeutics in Regard to Charge Variant Profile and Antigen Binding Affinity

(2018) Beate Beyer et al.   Biotechnology Journal

Biosimilarity assessment of biosimilar therapeutic monoclonal antibodies

(2018) Akiko Ishii-Watabe et al.   Drug Metabolism and Pharmacokinetics

Multi-column displacement chromatography for separation of charge variants of monoclonal antibodies

(2018) Ohnmar Khanal et al.   JOURNAL OF CHROMATOGRAPHY A

Non-protein A purification platform for continuous processing of monoclonal antibody therapeutics

(2018) Nikhil Kateja et al.   JOURNAL OF CHROMATOGRAPHY A

Determination of isoelectric points and relative charge variants of 23 therapeutic monoclonal antibodies

(2017) Alexandre Goyon et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Integrated Chromatographic Platform for Simultaneous Separation of Charge Variants and Aggregates from Monoclonal Antibody Therapeutic Products

(2017) Nikhil Kateja et al.   Biotechnology Journal

Advanced control strategies for the multicolumn countercurrent solvent gradient purification process

(2016) Maria M. Papathanasiou et al.   AICHE JOURNAL

Solvent modulated linear pH gradient elution for the purification of conventional and bispecific antibodies: Modeling and application

(2015) Simon Kluters et al.   JOURNAL OF CHROMATOGRAPHY A

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

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

Design of experiments applications in bioprocessing: Concepts and approach

(2013) Vijesh Kumar et al.   BIOTECHNOLOGY PROGRESS

Development of at-line assay to monitor charge variants of MAbs during production

(2013) M. M. St. Amand et al.   BIOTECHNOLOGY PROGRESS

Highly linear pH gradients for analyzing monoclonal antibody charge heterogeneity in the alkaline range

(2013) Nico Lingg et al.   JOURNAL OF CHROMATOGRAPHY A

Charge heterogeneity profiling of monoclonal antibodies using low ionic strength ion-exchange chromatography and well-controlled pH gradients on monolithic columns

(2013) Mohammad Talebi et al.   JOURNAL OF CHROMATOGRAPHY A

Periodic counter-current chromatography - design and operational considerations for integrated and continuous purification of proteins

(2012) Rahul Godawat et al.   Biotechnology Journal

Sample displacement chromatography as a method for purification of proteins and peptides from complex mixtures

(2012) Martina Srajer Gajdosik et al.   JOURNAL OF CHROMATOGRAPHY A

Managing uncertainty: A perspective on risk pertaining to product quality attributes as they bear on immunogenicity of therapeutic proteins

(2012) Amy S. Rosenberg et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Effects of Charge on Antibody Tissue Distribution and Pharmacokinetics

(2010) C. Andrew Boswell et al.   BIOCONJUGATE CHEMISTRY

Pharmacokinetic, pharmacodynamic and immunogenicity comparability assessment strategies for monoclonal antibodies

(2010) Wendy S. Putnam et al.   TRENDS IN BIOTECHNOLOGY

Multiproduct High-Resolution Monoclonal Antibody Charge Variant Separations by pH Gradient Ion-Exchange Chromatography

(2009) Dell Farnan et al.   ANALYTICAL CHEMISTRY

Separation of protein charge variants with induced pH gradients using anion exchange chromatographic columns

(2008) Timothy M. Pabst et al.   BIOTECHNOLOGY PROGRESS

Heterogeneity of Monoclonal Antibodies Revealed by Charge-Sensitive Methods

(2008) J. Vlasak et al.   CURRENT PHARMACEUTICAL BIOTECHNOLOGY

Heterogeneity of Monoclonal Antibodies

(2007) Hongcheng Liu et al.   JOURNAL OF PHARMACEUTICAL SCIENCES