4.3 Article

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

Related references

Note: Only part of the references are listed.
Review Pharmacology & Pharmacy

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

Narendra Chirmule et al.

AAPS JOURNAL (2012)

Article Biochemistry & Molecular Biology

Rates and impact of human antibody glycation in vivo

Andrew M. Goetze et al.

GLYCOBIOLOGY (2012)

Article Medicine, Research & Experimental

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

Bruce I. Mason et al.

MOLECULAR PHARMACEUTICS (2012)

Article Chemistry, Multidisciplinary

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

Rajsekhar Paul et al.

PHARMACEUTICAL RESEARCH (2012)

Article Biochemistry & Molecular Biology

Chemical Modifications in Therapeutic Protein Aggregates Generated under Different Stress Conditions

Quanzhou Luo et al.

JOURNAL OF BIOLOGICAL CHEMISTRY (2011)

Review Chemistry, Analytical

Intact protein analysis in the biopharmaceutical field

Aline Staub et al.

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS (2011)

Article Medicine, Research & Experimental

The impact of glycosylation on monoclonal antibody conformation and stability

Kai Zheng et al.

Editorial Material Chemistry, Multidisciplinary

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

John den Engelsman et al.

PHARMACEUTICAL RESEARCH (2011)

Article Biochemical Research Methods

Unique challenges of providing bioanalytical support for biological therapeutic pharmacokinetic programs

William L. Nowatzke et al.

BIOANALYSIS (2011)

Review Pharmacology & Pharmacy

Quality assessment of bioanalytical quantification of monoclonal antibody drugs

Jean W. Lee et al.

THERAPEUTIC DELIVERY (2011)

Review Pharmacology & Pharmacy

Protein aggregation-Pathways and influencing factors

Wei Wang et al.

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2010)

Article Biochemical Research Methods

Post-translational Modifications Differentially Affect IgG1 Conformation and Receptor Binding

Damian Houde et al.

MOLECULAR & CELLULAR PROTEOMICS (2010)

Review Chemistry, Multidisciplinary

Stability of Protein Pharmaceuticals: An Update

Mark Cornell Manning et al.

PHARMACEUTICAL RESEARCH (2010)

Article Biochemical Research Methods

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

Josef Vlasak et al.

ANALYTICAL BIOCHEMISTRY (2009)

Article Chemistry, Analytical

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

Kay Stubenrauch et al.

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS (2009)

Article Chemistry, Medicinal

The Effect of Sucrose Hydrolysis on the Stability of Protein Therapeutics during Accelerated Formulation Studies

Douglas D. Banks et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2009)

Review Chemistry, Medicinal

Effects of Glycosylation on the Stability of Protein Pharmaceuticals

Ricardo J. Sola et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2009)

Article Biochemistry & Molecular Biology

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

Andrea Bertolotti-Ciarlet et al.

MOLECULAR IMMUNOLOGY (2009)

Review Spectroscopy

MASS SPECTROMETRY FOR STRUCTURAL CHARACTERIZATION OF THERAPEUTIC ANTIBODIES

Zhongqi Zhang et al.

MASS SPECTROMETRY REVIEWS (2009)

Review Biochemistry & Molecular Biology

Heterogeneity of Monoclonal Antibodies Revealed by Charge-Sensitive Methods

J. Vlasak et al.

CURRENT PHARMACEUTICAL BIOTECHNOLOGY (2008)

Article Biochemical Research Methods

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

Georgeen Gaza-Bulseco et al.

JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES (2008)

Review Chemistry, Analytical

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

Gopi Shankar et al.

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS (2008)

Review Chemistry, Medicinal

Heterogeneity of monoclonal antibodies

Hongcheng Liu et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2008)

Article Chemistry, Multidisciplinary

Fragmentation of a recombinant monoclonal antibody at various pH

Georgeen Gaza-Bulseco et al.

PHARMACEUTICAL RESEARCH (2008)

Article Biochemistry & Molecular Biology

Effects of acid exposure on the conformation, stability, and aggregation of monoclonal antibodies

Daisuke Ejima et al.

PROTEINS-STRUCTURE FUNCTION AND BIOINFORMATICS (2007)

Article Biochemistry & Molecular Biology

Aspartate isomerization in the complementarity-determining regions of two closely related monoclonal antibodies

Aditya A. Wakankar et al.

BIOCHEMISTRY (2007)

Review Pharmacology & Pharmacy

Current and future issues in the manufacturing and development of monoclonal antibodies

Steven Kozlowski et al.

ADVANCED DRUG DELIVERY REVIEWS (2006)

Article Chemistry, Analytical

Formation of pyroglutamic acid from N-terminal glutamic acid in immunoglobulin gamma antibodies

D Chelius et al.

ANALYTICAL CHEMISTRY (2006)

Review Biotechnology & Applied Microbiology

Scientific and regulatory considerations on the immunogenicity of biologics

Gopi Shankar et al.

TRENDS IN BIOTECHNOLOGY (2006)

Article Biochemical Research Methods

Characterization by liquid chromatography combined with mass spectrometry of monoclonal anti-IGF-1 receptor antibodies produced in CHO and NSO cells

A Beck et al.

JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES (2005)

Article Biochemical Research Methods

Non-enzymatic hinge region fragmentation of antibodies in solution

AJ Cordoba et al.

JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES (2005)

Article Biotechnology & Applied Microbiology

Characterizing biological products and assessing comparability following manufacturing changes

AJ Chirino et al.

NATURE BIOTECHNOLOGY (2004)

Article Multidisciplinary Sciences

Protein deamidation

NE Robinson

PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA (2002)