Characterization of Labeled Reagents in Ligand-Binding Assays by A Surface Plasmon Resonance Biosensor

References

• Wang YM , JawaV, MaM. Immunogenicity and PK/PD evaluation in biotherapeutic drug development: scientific considerations for bioanalytical methods and data analysis. Bioanalysis6 (1), 79–87 (2014).
   PubMed Web of Science ®Google Scholar
• Lee JW . Method validation and application of protein biomarkers: basic similarities and differences from biotherapeutics. Bioanalysis1 (8), 1461–1474 (2009).
   PubMed Web of Science ®Google Scholar
• Mu J , PinkstaffJ, LiZet al. FGF21 analogs of sustained action enabled by orthogonal biosynthesis demonstrate enhanced antidiabetic pharmacology in rodents. Diabetes61 (2), 505–512 (2012).
   PubMed Web of Science ®Google Scholar
• Cho H , DanielT, BuechlerYJet al. Optimized clinical performance of growth hormone with an expanded genetic code. Proc. Natl Acad. Sci. USA108 (22), 9060–9065 (2011).
   PubMed Web of Science ®Google Scholar
• Adumeau P , SharmaSK, BrentCet al. Site-specifically labeled immunoconjugates for molecular imaging-part 1: cysteine residues and glycans. Mol. Imaging Biol. 18 (1), 1–17 (2016).
   PubMed Web of Science ®Google Scholar
• Adumeau P , SharmaSK, BrentCet al. Site-specifically labeled immunoconjugates for molecular imaging-part 2: peptide tags and unnatural amino acids. Mol. Imaging Biol. 18 (2), 153–165 (2016).
   PubMed Web of Science ®Google Scholar
• Zhang WJ , LuoX, LiuYLet al. Site-specific DOTA/europium-labeling of recombinant human relaxin-3 for receptor-ligand interaction studies. Amino Acids43 (2), 983–992 (2012).
   PubMed Web of Science ®Google Scholar
• Kim EG , KimKM. Strategies and advancement in antibody-drug conjugate optimization for targeted cancer therapeutics. Biomol. Ther. 23 (6), 493–509 (2015).
   PubMed Web of Science ®Google Scholar
• Wang L , AmphlettG, BlättlerWAet al. Structural characterization of the maytansinoid–monoclonal antibody immunoconjugate, huN901-DM1, by mass spectrometry. Protein Sci. 14 (9), 2436–2446 (2005).
   PubMed Web of Science ®Google Scholar
• King LE , FarleyE, ImazatoMet al. Ligand binding assay critical reagents and their stability: recommendations and best practices from the Global Bioanalysis Consortium Harmonization Team. AAPS J. 16 (3), 504–515 (2014).
   PubMed Web of Science ®Google Scholar
• O’Hara DM , TheobaldV, EganACet al. Ligand binding assays in the 21st century laboratory: recommendations for characterization and supply of critical reagents. AAPS J. 14 (2), 316–328 (2012).
   PubMed Web of Science ®Google Scholar
• Rup B , O’HaraD. Critical ligand binding reagent preparation/selection: when specificity depends on reagents. AAPS J. 9 (2), E148–E155 (2007).
   PubMed Web of Science ®Google Scholar
• Staack RF , StrackeJO, StubenrauchKet al. Quality requirements for critical assay reagents used in bioanalysis of therapeutic proteins: what bioanalysts should know about their reagents. Bioanalysis3 (5), 523–534 (2011).
   PubMed Web of Science ®Google Scholar
• Myler HA , PhillipsKR, DongHet al. Validation and life-cycle management of a quantitative ligand-binding assay for the measurement of Nulojix®, a CTLA-4-Fc fusion protein, in renal and liver transplant patients. Bioanalysis4 (10), 1215–1226 (2012).
   PubMed Web of Science ®Google Scholar
• O’Hara DM , TheobaldV. Life cycle management of critical ligand-binding reagents. Bioanalysis5 (21), 2679–2696 (2013).
   PubMed Web of Science ®Google Scholar
• Geist BJ , EganAC, YangTYet al. Characterization of critical reagents in ligand-binding assays: enabling robust bioanalytical methods and lifecycle management. Bioanalysis5 (2), 227–244 (2013).
   PubMed Web of Science ®Google Scholar
• Haulenbeek J , PiccoliSP. Conjugated critical reagent characterization for ligand-binding assays: using MALDI-TOF-MS as an orthogonal tool to assess assay performance. Bioanalysis6 (7), 983–992 (2014).
   PubMed Web of Science ®Google Scholar
• Abdiche Y , MalashockD, PinkertonAet al. Determining kinetics and affinities of protein interactions using a parallel real-time label-free biosensor, the Octet. Anal. Biochem. 377 (2), 209–217 (2008).
   PubMed Web of Science ®Google Scholar
• Liang M , KlakampSL, FunelasCet al. Detection of high- and low-affinity antibodies against a human monoclonal antibody using various technology platforms. Assay Drug Dev. Technol. 5 (5), 655–662 (2007).
   PubMed Web of Science ®Google Scholar
• Lofgren JA , DhandapaniS, PennucciJJet al. Comparing ELISA and surface plasmon resonance for assessing clinical immunogenicity of panitumumab. J. Immunol. 178 (11), 7467–7472 (2007).
   PubMed Web of Science ®Google Scholar
• Riedel T , MajekP, Rodriguez-EmmeneggerCet al. Surface plasmon resonance: advances of label-free approaches in the analysis of biological samples. Bioanalysis6 (24), 3325–3336 (2014).
   PubMed Web of Science ®Google Scholar
• Mytych DT , LaS, BargerTet al. The development and validation of a sensitive, dual-flow cell, SPR-based biosensor immunoassay for the detection, semi-quantitation, and characterization of antibodies to darbepoetin alfa and epoetin alfa in human serum. J. Pharm. Biomed. Anal. 49 (2), 415–426 (2009).
   PubMed Web of Science ®Google Scholar
• Müller KM , ArndtKM, PlückthunA. Model and simulation of multivalent binding to fixed ligands. Anal. Biochem. 261 (2), 149–158 (1998).
   PubMed Web of Science ®Google Scholar
• Patel R , AndrienBAJr. Kinetic analysis of a monoclonal therapeutic antibody and its single-chain homolog by surface plasmon resonance. Anal. Biochem. 396 (1), 59–68 (2010).
   PubMed Web of Science ®Google Scholar
• Pabbisetty KB , YueX, LiCet al. Kinetic analysis of the binding of monomeric and dimeric ephrins to Eph receptors: correlation to function in a growth cone collapse assay. Protein Sci. 16 (3), 355–361 (2007).
   PubMed Web of Science ®Google Scholar
• Schuck P , ZhaoH. The role of mass transport limitation and surface heterogeneity in the biophysical characterization of macromolecular binding processes by SPR biosensing. Methods Mol. Biol. 627 (1), 15–54 (2010).
   PubMedGoogle Scholar
• EZ-Link®, Sulfo-NHS-LC-Biotin. Thermo Scientific Product 21327 Instructions, Thermo Scientific, Rockford, IL, USA.
   Google Scholar