Characterization of critical reagents in ligand-binding assays: enabling robust bioanalytical methods and lifecycle management

Rapid comparison of a candidate biosimilar to an innovator monoclonal antibody with advanced liquid chromatography and mass spectrometry technologies

(2014) Hongwei Xie et al.   mAbs

Ligand Binding Assays in the 21st Century Laboratory: Recommendations for Characterization and Supply of Critical Reagents

(2012) Denise M. O’Hara et al.   AAPS Journal

Immunogenicity to Therapeutic Proteins: Impact on PK/PD and Efficacy

(2012) Narendra Chirmule et al.   AAPS Journal

General LC-MS/MS Method Approach to Quantify Therapeutic Monoclonal Antibodies Using a Common Whole Antibody Internal Standard with Application to Preclinical Studies

(2012) Hongyan Li et al.   ANALYTICAL CHEMISTRY

The impact of glycosylation on monoclonal antibody conformation and stability

(2012) Kai Zheng et al.   mAbs

Disulfide bond structures of IgG molecules

(2012) Hongcheng Liu et al.   mAbs

Effect of pH and Light on Aggregation and Conformation of an IgG1 mAb

(2012) Bruce D. Mason et al.   MOLECULAR PHARMACEUTICS

Structure and Function of Purified Monoclonal Antibody Dimers Induced by Different Stress Conditions

(2012) Rajsekhar Paul et al.   PHARMACEUTICAL RESEARCH

Bioanalytical Approaches to Quantify “Total” and “Free” Therapeutic Antibodies and Their Targets: Technical Challenges and PK/PD Applications Over the Course of Drug Development

(2011) Jean W. Lee et al.   AAPS Journal

Advances and challenges in analytical characterization of biotechnology products: Mass spectrometry-based approaches to study properties and behavior of protein therapeutics

(2011) Igor A. Kaltashov et al.   BIOTECHNOLOGY ADVANCES

Rates and impact of human antibody glycation in vivo

(2011) A. M. Goetze et al.   GLYCOBIOLOGY

Chemical Modifications in Therapeutic Protein Aggregates Generated under Different Stress Conditions

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

Intact protein analysis in the biopharmaceutical field

(2011) Aline Staub et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Quality requirements for critical assay reagents used in bioanalysis of therapeutic proteins: what bioanalysts should know about their reagents

(2011) Roland F Staack et al.   Bioanalysis

Unique challenges of providing bioanalytical support for biological therapeutic pharmacokinetic programs

(2011) William L Nowatzke et al.   Bioanalysis

Protein aggregation—Pathways and influencing factors

(2010) Wei Wang et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

Comparative Effects of pH and Ionic Strength on Protein–Protein Interactions, Unfolding, and Aggregation for IgG1 Antibodies

(2010) Erinc Sahin et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Post-translational Modifications Differentially Affect IgG1 Conformation and Receptor Binding

(2010) Damian Houde et al.   MOLECULAR & CELLULAR PROTEOMICS

Stability of Protein Pharmaceuticals: An Update

(2010) Mark Cornell Manning et al.   PHARMACEUTICAL RESEARCH

Strategies for the Assessment of Protein Aggregates in Pharmaceutical Biotech Product Development

(2010) John den Engelsman et al.   PHARMACEUTICAL RESEARCH

Increased aggregation propensity of IgG2 subclass over IgG1: Role of conformational changes and covalent character in isolated aggregates

(2010) Heather Franey et al.   PROTEIN SCIENCE

Identification and characterization of asparagine deamidation in the light chain CDR1 of a humanized IgG1 antibody

(2009) Josef Vlasak et al.   ANALYTICAL BIOCHEMISTRY

Development of Different Analysis Platforms with LC−MS for Pharmacokinetic Studies of Protein Drugs

(2009) Qiaozhen Lu et al.   ANALYTICAL CHEMISTRY

Evaluation of an immunoassay for human-specific quantitation of therapeutic antibodies in serum samples from non-human primates

(2009) Kay Stubenrauch et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

The effect of sucrose hydrolysis on the stability of protein therapeutics during accelerated formulation studies

(2009) Douglas D. Banks et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Electrospray ionization quadrupole ion-mobility time-of-flight mass spectrometry as a tool to distinguish the lot-to-lot heterogeneity in N-glycosylation profile of the therapeutic monoclonal antibody trastuzumab

(2009) Carola W. N. Damen et al.   JOURNAL OF THE AMERICAN SOCIETY FOR MASS SPECTROMETRY

Impact of methionine oxidation on the binding of human IgG1 to FcRn and Fcγ receptors

(2009) Andrea Bertolotti-Ciarlet et al.   MOLECULAR IMMUNOLOGY

Immunopurification and Mass Spectrometric Quantification of the Active Form of a Chimeric Therapeutic Antibody in Human Serum

(2008) Mathieu Dubois et al.   ANALYTICAL CHEMISTRY

Isomerization of a Single Aspartyl Residue of Anti-Epidermal Growth Factor Receptor Immunoglobulin γ2 Antibody Highlights the Role Avidity Plays in Antibody Activity

(2008) Douglas S. Rehder et al.   BIOCHEMISTRY

Heterogeneity of Monoclonal Antibodies Revealed by Charge-Sensitive Methods

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

Effect of methionine oxidation of a recombinant monoclonal antibody on the binding affinity to protein A and protein G

(2008) Georgeen Gaza-Bulseco et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products

(2008) Gopi Shankar et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Effects of glycosylation on the stability of protein pharmaceuticals

(2008) Ricardo J. Solá et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Mass spectrometry for structural characterization of therapeutic antibodies

(2008) Zhongqi Zhang et al.   MASS SPECTROMETRY REVIEWS

Fragmentation of a Recombinant Monoclonal Antibody at Various pH

(2008) Georgeen Gaza-Bulseco et al.   PHARMACEUTICAL RESEARCH

Heterogeneity of Monoclonal Antibodies

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

Proteolysis of purified IgGs by human and bacterial enzymes in vitro and the detection of specific proteolytic fragments of endogenous IgG in rheumatoid synovial fluid

(2007) Mary H. Ryan et al.   MOLECULAR IMMUNOLOGY