Anti-Drug Antibodies

Anti-Drug Antibodies

Industry Publications from BioAgilytix’s Expert Scientists

Explore the extensive list of ADA publications to which BioAgilytix’s scientists have contributed:

Recommendations for the Development and Validation of Neutralizing Antibody Assays in Support of Biosimilar Assessment.
Gouty D, Cai CC, Cai XY, Kasinath A, Kumar V, Alvandkouhi S, Yang J, Pederson S, Babbitt B, Peritt D, Rudy A, Koppenburg V, Dasilva A, Ullmann M, Liu S, Satterwhite C. AAPS J. 2017 Dec 28;20(1):25. doi: 10.1208/s12248-017-0181-6.
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Immunogenicity considerations for antibody-drug conjugates: a focus on neutralizing antibody assays.
Fiorotti CK. Bioanalysis. 2018 Jan;10(2):65-70
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The quintessence of immunogenicity reporting for Biotherapeutics.
Shankar G, Arkin S, Devanarayan V, Kromminga A, Quarmby V, Richards S, Subramanyam M, Swanson S. Nat Biotechnol. 2015 Apr;33(4):334-6. doi: 10.1038/nbt.3181. 
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Recommendations for the development and validation of confirmatory anti-drug antibody assays.
Jani D, Marsden R, Mikulskis A, Gleason C, Klem T, Krinos Fiorotti C, Myler H, Yang L, Fiscella M. Bioanalysis. 2015;7(13):1619-31.
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Managing unwanted immunogenicity of biologicals.
Deehan M, Garcês S, Kramer D, Baker MP, Rat D, Roettger Y, Kromminga A. Autoimmun Rev. 2015 Jul; 14(7):569-74. doi: 10.1016/j.autrev.2015.02.007. Epub 2015 Mar 2. Review.
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Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations.
Shankar G, Arkin S, Cocea L, Devanarayan V, Kirshner S, Kromminga A, Quarmby V, Richards S, Schneider CK, Subramanyam M, Swanson S, Verthelyi D, Yim S; American Association of Pharmaceutical Scientists. AAPS J. 2014 Jul;16(4):658-73. doi: 10.1208/s12248-014-9599-2. Epub 2014 Apr 24.
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eBook: Bioanalysis for Biosimilars Development
Gouty, 2015. Bioanalysis Zone
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2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 – LBA and immunogenicity).
Stevenson L, Gouty D, Yang TY et al. Bioanalysis. 2014; 6(24):3355-68. doi: 10.4155/bio.14.283.
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Challenges of developing and validating immunogenicity assays to support comparability studies for biosimilar drug development.
Cai XY, Thomas J, Cullen C, Gouty D.Bioanalysis. 2012 Sep; 4(17):2169-77. Review.
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