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PLoS ONE, ISSN 1932-6203, 06/2014, Volume 9, Issue 6, p. e100736
Journal Article
PLoS ONE, ISSN 1932-6203, 07/2012, Volume 7, Issue 7, p. e40328
Sequence variants in recombinant biopharmaceuticals may have a relevant and unpredictable impact on clinical safety and efficacy. Hence, their sensitive... 
HETEROGENEITY | THERAPEUTICS | MONOCLONAL-ANTIBODIES | MISINCORPORATION | MULTIDISCIPLINARY SCIENCES | Immunoglobulin G - isolation & purification | Sequence Analysis, Protein - methods | Humans | Molecular Sequence Data | Recombinant Proteins - isolation & purification | Reference Standards | Proteolysis | Base Sequence | Antibodies, Monoclonal - chemistry | CHO Cells | Amino Acid Sequence | Cricetinae | Tandem Mass Spectrometry - standards | Immunoglobulin G - chemistry | Recombinant Proteins - chemistry | Recombinant Proteins - genetics | Antibodies, Monoclonal - isolation & purification | Sequence Analysis, DNA | Antibodies, Monoclonal - genetics | Point Mutation | Peptide Fragments - chemistry | Animals | Immunoglobulin G - genetics | Phenylalanine - genetics | High-Throughput Nucleotide Sequencing | Software | Chromatography, Gel | Trypsin - chemistry | Amino Acid Substitution | Case studies | Purines | Pyrimidines | Biological products | Peptides | Amino acids | Comparative analysis | Fermentation | Recombinant proteins | Product quality | Cytotoxicity | Quantitation | Isomers | Amino acid substitution | Substitutes | Proteins | Epidermal growth factor | E coli | Developmental stages | Cytosine | Elongation | Deoxyribonucleic acid--DNA | Recombinant | Data analysis | Immunoglobulins | Adenine | Low level | Chromatography | Acids | Cell lines | Proteomics | Scientific imaging | Mutation | Aberration | Glycopeptides | Mass spectrometry | Deoxyribonucleic acid | DNA
Journal Article
mAbs, ISSN 1942-0862, 09/2014, Volume 6, Issue 5, pp. 1229 - 1242
Journal Article
mAbs, ISSN 1942-0862, 07/2013, Volume 5, Issue 4, pp. 576 - 586
The neonatal Fc receptor (FcRn) is important for the metabolic fate of IgG antibodies in vivo. Analysis of the interaction between FcRn and IgG in vitro might... 
neonatal Fc receptor | methionine oxidation | affinity chromatography | antibody | pH gradient | FcRn | pharmacokinetics | column | degradation | PK | Degradation | Affinity chromatography | Antibody | Column | Neonatal fc receptor | Pharmacokinetics | Methionine oxidation | HALF-LIFE | THERAPEUTICS | MEDICINE, RESEARCH & EXPERIMENTAL | COMPLEX | STOICHIOMETRY | GAMMA RECEPTORS | HUMAN IGG1 | LIGAND | IMMUNOGLOBULIN-G | BINDING | Surface Plasmon Resonance | Immunoglobulin G - isolation & purification | Humans | Immunoglobulin Fc Fragments - immunology | Immunoglobulin G - immunology | Chromatography, Affinity - methods | Receptors, Fc - chemistry | Antibodies, Monoclonal, Murine-Derived - immunology | Immunoglobulin G - chemistry | Histocompatibility Antigens Class I - immunology | Immunoglobulin Fc Fragments - chemistry | Mice, Transgenic | Histocompatibility Antigens Class I - genetics | Antibodies, Monoclonal, Murine-Derived - analysis | Histocompatibility Antigens Class I - chemistry | Immunoglobulin Fc Fragments - isolation & purification | Animals | Immunoglobulin G - genetics | Receptors, Fc - immunology | Receptors, Fc - genetics | Mutation | Antibodies, Monoclonal, Murine-Derived - genetics | Immunoglobulin Fc Fragments - genetics | Antibodies, Monoclonal, Murine-Derived - isolation & purification | Hydrogen-Ion Concentration | Report
Journal Article
Bioanalysis, ISSN 1757-6180, 12/2015, Volume 7, Issue 24, pp. 3097 - 3106
Aim: During development of biologics, safety and efficacy assessments are often hampered by immune responses to the treatment. The raised antidrug antibodies... 
antidrug antibody | ligand-binding assay | quantification | cell-based assay | drug exposure | active drug | immunogenicity | free drug | ANTIBODIES | CHEMISTRY, ANALYTICAL | BIOCHEMICAL RESEARCH METHODS | LC-MS/MS | IMPACT | THERAPEUTIC PROTEINS | BIOANALYSIS | ELISA
Journal Article
Bioanalysis, ISSN 1757-6180, 12/2016, Volume 8, Issue 24, pp. 2537 - 2549
Aim: Active drug assays are becoming increasingly important in protein drug development. We describe the validation of a ligand-binding assay for active... 
specific matrix effect | ligand-binding assay | active drug | surrogate matrix | ELISA | free analyte QC concept | CHEMISTRY, ANALYTICAL | EFFICACY | BIOCHEMICAL RESEARCH METHODS | LARGE-MOLECULE BIOANALYSIS | SERUM SAMPLES | LC-MS/MS | IMMUNOGENICITY | IMMUNOTOXIN | IMMUNOASSAY | RG7787 | THERAPEUTIC MONOCLONAL-ANTIBODY
Journal Article
Bioanalysis, ISSN 1757-6180, 12/2016, Volume 8, Issue 23, pp. 2475 - 2496
The 2016 10th Workshop on Recent Issues in Bioanalysis (10th WRIB) took place in Orlando, Florida with participation of close to 700 professionals from... 
BISPECIFIC ANTIBODIES | CHEMISTRY, ANALYTICAL | PRACTICE GUIDELINES | FULL IMMERSION | BIOCHEMICAL RESEARCH METHODS | DRUG DEVELOPMENT | RECEPTOR OCCUPANCY ASSAYS | FLOW-CYTOMETRY | REGULATED BIOANALYSIS | 2-HYBRID LBA/LCMS | GROUP WORKSHOP | 1-SMALL MOLECULES
Journal Article
Bioanalysis, ISSN 1757-6180, 03/2011, Volume 3, Issue 5, pp. 523 - 534
Ligand-binding assays are the standard technology used for bioanalysis of therapeutic proteins, for example, for drug quantification (pharmacokinetics assays)... 
IMMUNOGENICITY | CHEMISTRY, MEDICINAL | MACROMOLECULES | LIGAND-BINDING ASSAYS | RECOMMENDATIONS | METHOD VALIDATION | BIOTECHNOLOGY PRODUCTS | HUMAN SERA | BIOCHEMICAL RESEARCH METHODS | IMMUNOASSAYS | MONOCLONAL-ANTIBODIES | HOST ANTIBODIES
Journal Article
Bioanalysis, ISSN 1757-6180, 12/2015, Volume 7, Issue 24, pp. 3063 - 3072
Background: During development of biologics, safety and efficacy assessments are often hampered by immune responses to the treatment. To assess active exposure... 
CHEMISTRY, ANALYTICAL | RECOMMENDATIONS | BIOTECHNOLOGY PRODUCTS | QUANTITATION | BIOCHEMICAL RESEARCH METHODS | VALIDATION | SERUM | PROTEINS | HOST ANTIBODIES | BIOANALYSIS | Index Medicus
Journal Article
Journal Article
Bioanalysis, ISSN 1757-6180, 12/2017, Volume 9, Issue 24, pp. 1967 - 1996
The 2017 11th Workshop on Recent Issues in Bioanalysis took place in Los Angeles/Universal City, California, on 3-7 April 2017 with participation of close to... 
REGULATORY AGENCIES | ANTIBODIES | CHEMISTRY, ANALYTICAL | RECOMMENDATIONS | FULL IMMERSION | FOCUS | BIOCHEMICAL RESEARCH METHODS | DRUG QUANTIFICATION | VALIDATION GROUP WORKSHOP | 2-HYBRID LBA/LCMS | LCMS | 1-SMALL MOLECULES
Journal Article