Antibody–Drug Conjugate Drug Development: Where are The Challenges?

Abstract

BioanalysisVol. 5, No. 12 EditorialAntibody–drug conjugate drug development: where are the challenges?Laura Wright, Sharon Baughman & Ashleigh WakeLaura Wright* Author for correspondenceIntertek Pharmaceutical Services, 3985 Sorrento Valley Blvd Suite C, San Diego, CA 92121, USA. Search for more papers by this authorEmail the corresponding author at laura.wright@intertek.com, Sharon BaughmanProPharma Services, LLC, 1050 Driftwood Lane, Ventura, CA 93001, USASearch for more papers by this author & Ashleigh WakeIntertek Pharmaceutical Services, Hexagon Tower, PO Box 42, Crumpsall Vale, BlackleyManchester, M9 8ZS, UKSearch for more papers by this authorPublished Online:24 Jun 2013https://doi.org/10.4155/bio.13.104AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail View articleKeywords: antibody–drug conjugatebiopharmaceuticalsdrug-to-antibody ratioPKReferences1 Shapiro M, Chen X. Regulatory considerations when developing assays for the characterization and quality control of antibody–drug conjugates. American Laboratory, 27 August (2012).Google Scholar2 US FDA. ICH Guideline Q11 on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities). US FDA, Washington, DC, USA (2012).Google Scholar3 European Medicines Agency. Guideline on Development, Production, Characterization and Specifications For Monoclonal Antibodies And Related Products, EMEA/CHMP/BWP/157653/2007. European Medicines Agency, London, UK (2008).Google Scholar4 Wakankar A, Chen Y, Gokarn Y, Jacobson FS. Analytical methods for physiochemical characterization of antibody drug conjugates. mAbs3(2),161–172 (2011).Crossref, Medline, Google Scholar5 Beck A, Wurch T, Bailly C, Corvaia N. Strategies and challenges for the next generation of therapeutic antibodies. Nat. Rev. Immunol.10(5),345–352 (2010).Crossref, Medline, CAS, Google Scholar6 Sanderson RJ, Hering MA, James SF et al.In vivo drug–linker stability of an anti-CD30 dipeptide-linked auristatin immunoconjugate. Clin. Cancer Res.11,843 (2005).Medline, CAS, Google Scholar7 Xiao Y, Halford A, Hayes R. Meeting challenges for analysis of antibody–drug conjugates. BioPharm Int.25(10),60–63 (2012).CAS, Google Scholar8 Kaur S, Xu K, Saad O, Dere R, Carrasco-Triguero M. Bioanalytical assay strategies for the development of antibody–drug conjugate biotherapuetics. Bioanalysis5(2),201–206 (2013).Link, CAS, Google Scholar101 Wyatt Technology. Technical note: antibody drug conjugate analysis (ADC). www.wyatt.com/files/literature/Antibody_Drug_Conjugate_(ADC)_Analysis.pdfGoogle ScholarFiguresReferencesRelatedDetails Vol. 5, No. 12 Follow us on social media for the latest updates Metrics Downloaded 641 times History Published online 24 June 2013 Published in print June 2013 Information© Future Science LtdKeywordsantibody–drug conjugatebiopharmaceuticalsdrug-to-antibody ratioPKFinancial & competing interests disclosureThe authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.No writing assistance was utilized in the production of this manuscript.PDF download