Recommendations for Validation of LC-MS/MS Bioanalytical Methods for Protein Biotherapeutics

Ligand Binding Assay Critical Reagents and Their Stability: Recommendations and Best Practices from the Global Bioanalysis Consortium Harmonization Team

(2014) Lindsay E. King et al.   AAPS Journal

A multiplexed hybrid LC–MS/MS pharmacokinetic assay to measure two co-administered monoclonal antibodies in a clinical study

(2014) Keyang Xu et al.   Bioanalysis

High-Sensitivity LC-MS/MS Quantification of Peptides and Proteins in Complex Biological Samples: The Impact of Enzymatic Digestion and Internal Standard Selection on Method Performance

(2013) Kees J. Bronsema et al.   ANALYTICAL CHEMISTRY

Fully Validated LC-MS/MS Assay for the Simultaneous Quantitation of Coadministered Therapeutic Antibodies in Cynomolgus Monkey Serum

(2013) Hao Jiang et al.   ANALYTICAL CHEMISTRY

Development of a validated liquid chromatography tandem mass spectrometry assay for a PEGylated adnectin in cynomolgus monkey plasma using protein precipitation and trypsin digestion

(2013) Michelle L. Dawes et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Bioanalytical LC–MS/MS of protein-based biopharmaceuticals

(2013) Irene van den Broek et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Bioanalysis of antibody–drug conjugates: American Association of Pharmaceutical Scientists Antibody–Drug Conjugate Working Group position paper

(2013) Boris Gorovits et al.   Bioanalysis

LC–MS/MS of large molecules in a regulated bioanalytical environment – which acceptance criteria to apply?

(2013) Magnus Knutsson et al.   Bioanalysis

Bioanalytical assay strategies for the development of antibody–drug conjugate biotherapeutics

(2013) Surinder Kaur et al.   Bioanalysis

Simultaneous Analysis of Multiple Monoclonal Antibody Biotherapeutics by LC-MS/MS Method in Rat Plasma Following Cassette-Dosing

(2012) Hongyan Li 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

Internal standards in the quantitative determination of protein biopharmaceuticals using liquid chromatography coupled to mass spectrometry

(2012) Kees J. Bronsema et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Differentiation and quantification of endogenous and recombinant-methionyl human leptin in clinical plasma samples by immunocapture/mass spectrometry

(2012) Yan Wang et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Pitfalls in Protein Quantitation Using Acid-Catalyzed O18Labeling: Hydrolysis-Driven Deamidation

(2011) Shunhai Wang et al.   ANALYTICAL CHEMISTRY

Comparability analysis of protein therapeutics by bottom-up LC-MS with stable isotope-tagged reference standards

(2011) Anton V. Manuilov et al.   mAbs

Online immunoaffinity LC/MS/MS. A general method to increase sensitivity and specificity: How do you do it and what do you need?

(2011) Dawn R. Dufield et al.   METHODS

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

Ligand-Binding Mass Spectrometry to Study Biotransformation of Fusion Protein Drugs and Guide Immunoassay Development: Strategic Approach and Application to Peptibodies Targeting the Thrombopoietin Receptor

(2010) Michael P. Hall et al.   AAPS Journal

A Universal Strategy for Development of a Method for Absolute Quantification of Therapeutic Monoclonal Antibodies in Biological Matrices Using Differential Dimethyl Labeling Coupled with Ultra Performance Liquid Chromatography-Tandem Mass Spectrometry

(2009) Chengjie Ji et al.   ANALYTICAL CHEMISTRY

Towards Absolute Quantification of Therapeutic Monoclonal Antibody in Serum by LC−MS/MS Using Isotope-Labeled Antibody Standard and Protein Cleavage Isotope Dilution Mass Spectrometry

(2008) Olivier Heudi et al.   ANALYTICAL CHEMISTRY