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• W2989772047 abstract "Future Science Book SeriesBioanalysis of Biotherapeutics Bioanalysis of antibody–drug conjugatesBoris GorovitsBoris GorovitsBoris Gorovits is Director at the Pharmacokinetics, Pharmacodynamics and Metabolism Department of Pfizer Inc. (MA, USA). He earned his PhD in enzymology at Moscow State University (Russia) and then completed his postdoctoral studies in protein biophysics at the University of Texas at San Antonio Medical Center (USA). He later joined Wyeth Research (now Pfizer), where he currently leads a bioanalytical laboratory responsible for support of the research and development of protein-based pharmaceuticals. His research is focused on the development and utilization of pharmacokinetic assays, as well as assays designed to evaluate the development of immune responses to biotherapeutic compounds.Search for more papers by this authorPublished Online:11 Oct 2013https://doi.org/10.4155/ebo.13.285AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack Citations ShareShare onFacebookTwitterLinkedInReddit View chapterAbstract: Antibody–drug conjugates (ADCs) combine high-specificity antibody-based targeting with the potent cytotoxic activity of a small-molecular-weight drug (payload). By ensuring specific delivery of the cytotoxic drug to the targeted cell type, ADC compounds promise to improve the overall safety and reduce nonspecific off-target toxicity typically found for small-molecule therapeutics. Based on the nature of conjugation chemistries used to link small-molecule drug with the protein carrier, ADC compounds are generally complex heterogeneous mixtures. Bioanalytical evaluation of ADC compounds therefore presents unique challenges with a number of potential analytes to monitor. Concepts and considerations involved in creating a successful bioanalytical strategy for an ADC compound allowing for an improved understanding of the exposure–response relationship are discussed in this chapter. References1 Teicher BA , Chari RVJ Antibody conjugate therapeutics: challenges and potential . Clin. Cancer Res. 17 (20) , 6389 – 6397 (2011) . Crossref, Medline, CAS, Google Scholar2 Wu AM , Senter PD . Arming antibodies: prospects and challenges for immunoconjugates . Nat. Biotechnol. 23 (9) , 1137 – 1146 (2005) . Crossref, Medline, CAS, Google Scholar3 Gorovits B , Alley S , Bilic S et al. Considerations for the bioanalysis of antibody drug conjugates. 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Contribution of linker stability to the activities of anticancer immunoconjugates . Bioconjug. Chem. 19 (3) , 759 – 765 (2008) . Crossref, Medline, CAS, Google Scholar16 Buckwalter M , Dowell JA , Korth-Bradley J , Gorovits B , Mayer PR . Pharmacokinetics of gemtuzumab ozogamicin as a single-agent treatment of pediatric patients with refractory or relapsed acute myeloid leukemia . J. Clin. Pharmacol. 44 (8) , 873 – 880 (2004) . Crossref, Medline, CAS, Google Scholar17 Lin K , Tibbitts J . Pharmacokinetic considerations for antibody drug conjugates . Pharm. Res. 29 (9) , 2354 – 2366 (2012) . Crossref, Medline, CAS, Google Scholar18 Stephan JP , Kozak KR , Wong WLT Challenges in developing bioanalytical assays for characterization of antibody–drug conjugates . Bioanalysis 3 (6) , 677 – 700 (2011) . Crossref, Medline, CAS, Google Scholar19 US FDA. Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins. Draft Guideline. US FDA, DC, USA (2009) . 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Google ScholarFiguresReferencesRelatedDetails Bioanalysis of BiotherapeuticsMetrics Downloaded 42 times History Published online 11 October 2013 Published in print October 2013 Information© Future Science Ltd© Future Science LtdPDF download" @default.
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