Enhanced product understanding in the QbD paradigm: linkage between charge heterogeneity and stability of monoclonal antibody therapeutic products

Multivariate Analysis and Statistics in Pharmaceutical Process Research and Development

(2017) José E. Tabora et al.   Annual Review of Chemical and Biomolecular Engineering

Mechanistic Modeling Based PAT Implementation for Ion-Exchange Process Chromatography of Charge Variants of Monoclonal Antibody Products

(2017) Vijesh Kumar et al.   Biotechnology Journal

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

(2017) Nikhil Kateja et al.   Biotechnology Journal

Microheterogeneity of therapeutic monoclonal antibodies is governed by changes in the surface charge of the protein

(2016) Beate Hintersteiner et al.   Biotechnology Journal

Evaluation of the potential for QTc prolongation in patients with solid tumors receiving nivolumab

(2016) Shruti Agrawal et al.   CANCER CHEMOTHERAPY AND PHARMACOLOGY

Should charge variants of monoclonal antibody therapeutics be considered critical quality attributes?

(2016) Sumit Kumar Singh et al.   ELECTROPHORESIS

Reversible NaCl-induced aggregation of a monoclonal antibody at low pH: Characterization of aggregates and factors affecting aggregation

(2016) Fabian Bickel et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Charge heterogeneity: Basic antibody charge variants with increased binding to Fc receptors

(2016) Beate Hintersteiner et al.   mAbs

Microheterogeneity of therapeutic monoclonal antibodies is governed by changes in the surface charge of the protein

(2016) Beate Hintersteiner et al.   Biotechnology Journal

Investigating the Degradation Behaviors of a Therapeutic Monoclonal Antibody Associated with pH and Buffer Species

(2015) Songyan Zheng et al.   AAPS PHARMSCITECH

Rapid analysis of charge variants of monoclonal antibodies using non-linear salt gradient in cation-exchange high performance liquid chromatography

(2015) Varsha Joshi et al.   JOURNAL OF CHROMATOGRAPHY A

Monoclonal Antibodies Follow Distinct Aggregation Pathways During Production-Relevant Acidic Incubation and Neutralization

(2015) Thomas Skamris et al.   PHARMACEUTICAL RESEARCH

Avoiding antibody aggregation during processing: Establishing hold times

(2014) Varsha Joshi et al.   Biotechnology Journal

Guidance for performing multivariate data analysis of bioprocessing data: Pitfalls and recommendations

(2014) Anurag S. Rathore et al.   BIOTECHNOLOGY PROGRESS

Immunogenicity of therapeutic proteins: Influence of aggregation

(2013) Kirsty D. Ratanji et al.   Journal of Immunotoxicology

A Consensus Method for the Prediction of ‘Aggregation-Prone’ Peptides in Globular Proteins

(2013) Antonios C. Tsolis et al.   PLoS One

Chromatographic analysis of the acidic and basic species of recombinant monoclonal antibodies

(2012) Yi Du et al.   mAbs

Aggregates in monoclonal antibody manufacturing processes

(2011) María Vázquez-Rey et al.   BIOTECHNOLOGY AND BIOENGINEERING

Chemical Modifications in Therapeutic Protein Aggregates Generated under Different Stress Conditions

(2011) Quanzhou Luo et al.   JOURNAL OF BIOLOGICAL CHEMISTRY

Aggregation in Protein-Based Biotherapeutics: Computational Studies and Tools to Identify Aggregation-Prone Regions

(2011) Neeraj J. Agrawal et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Charge variants in IgG1

(2010) Leslie A. Khawli et al.   mAbs

Development trends for human monoclonal antibody therapeutics

(2010) Aaron L. Nelson et al.   NATURE REVIEWS DRUG DISCOVERY

Stability of Protein Pharmaceuticals: An Update

(2010) Mark Cornell Manning et al.   PHARMACEUTICAL RESEARCH

Monoclonal antibody interactions with micro- and nanoparticles: Adsorption, aggregation, and accelerated stress studies

(2009) Jared S. Bee et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Structure and Stability Changes of Human IgG1 Fc as a Consequence of Methionine Oxidation

(2008) Dingjiang Liu et al.   BIOCHEMISTRY

Application of Multivariate Data Analysis for Identification and Successful Resolution of a Root Cause for a Bioprocessing Application

(2008) A.O. Kirdar et al.   BIOTECHNOLOGY PROGRESS

Effect of Ions on Agitation- and Temperature-Induced Aggregation Reactions of Antibodies

(2008) R. Matthew Fesinmeyer et al.   PHARMACEUTICAL RESEARCH

Removal of Cysteinylation from an Unpaired Sulfhydryl in the Variable Region of a Recombinant Monoclonal IgG1 Antibody Improves Homogeneity, Stability, and Biological Activity

(2007) Douglas D. Banks et al.   JOURNAL OF PHARMACEUTICAL SCIENCES