Publications by authors named "James Bourdage"

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Immunogenicity of avelumab in patients with metastatic Merkel cell carcinoma or advanced urothelial carcinoma.
Ping Hu, Haiqing Isaac Dai, James Bourdage, Dongli Zhou, Ky Trang

Clin Transl Sci· March 2024

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12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity.
Chad Briscoe, Nicola Hughes, Roger Hayes, Rafiq Islam, Patrick Bennett, James Bourdage

Bioanalysis· June 2019

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Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis.
Rafiq Islam, Sumit Kar, Hanna Ritzén, Amanda Hays, Rabab Tayyem, James Bourdage

Bioanalysis· April 2019

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11th GCC Closed Forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation.
Rafiq Islam, Chad Briscoe, Joseph Bower, Stephanie Cape, Mark Arnold, James Bourdage

Bioanalysis· April 2018

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The 10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud.
Stephanie Cape, Rafiq Islam, Corey Nehls, John Allinson, Afshin Safavi, James Bourdage

Bioanalysis· April 2017

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9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks.
Roger Hayes, Richard LeLacheur, Isabelle Dumont, Philippe Couerbe, Afshin Safavi, James Bourdage

Bioanalysis· March 2016

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Recombinant protective antigen anthrax vaccine improves survival when administered as a postexposure prophylaxis countermeasure with antibiotic in the New Zealand white rabbit model of inhalation anthrax.
Elizabeth K Leffel, James S Bourdage, E Diane Williamson, Matthew Duchars, Thomas R Fuerst

Clin Vaccine Immunol· August 2012

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A novel method for quantitative measurement of a biomarker in the presence of a therapeutic monoclonal antibody directed against the biomarker.
R Aleks Davis, Anthony M Butterfield, Robert J Konrad, James S Bourdage

J Pharm Biomed Anal· November 2008

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An Affinity Capture Elution (ACE) assay for detection of anti-drug antibody to monoclonal antibody therapeutics in the presence of high levels of drug.
James S Bourdage, Carolyn A Cook, Daphne L Farrington, Jana S Chain, Robert J Konrad

J Immunol Methods· October 2007

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Effect of double antigen bridging immunoassay format on antigen coating concentration dependence and implications for designing immunogenicity assays for monoclonal antibodies.
James S Bourdage, Thomas N Lee, J Michael Taylor, Mark B Willey, John T Brandt

J Pharm Biomed Anal· September 2005

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Differential reactivity of anti-primate and anti-human secondary antibodies against human and monkey immunoglobulins: implications for determining the sensitivity of immunogenicity assays.
James S Bourdage, John T Brandt, Thomas N Lee, Robert J Konrad

J Immunol Methods· August 2005

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