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Editorial

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

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Pages 1467-1469 | Published online: 24 Jun 2013

References

  • Shapiro M , ChenX. Regulatory considerations when developing assays for the characterization and quality control of antibody–drug conjugates. American Laboratory, 27 August (2012).
  • US FDA . ICH Guideline Q11 on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities). US FDA, Washington, DC, USA (2012).
  • 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).
  • Wakankar A , ChenY, GokarnY, JacobsonFS. Analytical methods for physiochemical characterization of antibody drug conjugates. mAbs3(2), 161–172 (2011).
  • Beck A , WurchT, BaillyC, CorvaiaN. Strategies and challenges for the next generation of therapeutic antibodies. Nat. Rev. Immunol. 10(5), 345–352 (2010).
  • Sanderson RJ , HeringMA, JamesSFet al. In vivo drug–linker stability of an anti-CD30 dipeptide-linked auristatin immunoconjugate. Clin. Cancer Res. 11, 843 (2005).
  • Xiao Y , HalfordA, HayesR. Meeting challenges for analysis of antibody–drug conjugates. BioPharm Int. 25(10), 60–63 (2012).
  • Kaur S , XuK, SaadO, DereR, Carrasco-TrigueroM. Bioanalytical assay strategies for the development of antibody–drug conjugate biotherapuetics. Bioanalysis5(2), 201–206 (2013).

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