Research ArticleANTI-DRUG ANTIBODIES

Post hoc assessment of the immunogenicity of bioengineered factor VIIa demonstrates the use of preclinical tools

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Science Translational Medicine  11 Jan 2017:
Vol. 9, Issue 372, eaag1286
DOI: 10.1126/scitranslmed.aag1286

Article Information

vol. 9 no. 372

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History: 
  • Received for publication January 4, 2016
  • Resubmitted May 12, 2016
  • Accepted for publication December 5, 2016
  • .

Author Information

  1. Kasper Lamberth1,*,
  2. Stine Louise Reedtz-Runge1,
  3. Jonathan Simon2,
  4. Ksenia Klementyeva2,
  5. Gouri Shankar Pandey2,
  6. Søren Berg Padkjær1,
  7. Véronique Pascal1,
  8. Ileana R. León1,
  9. Charlotte Nini Gudme1,
  10. Søren Buus3 and
  11. Zuben E. Sauna2,*
  1. 1Global Research, Novo Nordisk A/S, Novo Nordisk Park, DK-2760 Måløv, Denmark.
  2. 2Hemostasis Branch, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapeutics, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.
  3. 3Laboratory of Experimental Immunology, Faculty of Health Sciences, University of Copenhagen, DK-2200 Copenhagen, Denmark.
  1. *Corresponding author. Email: zuben.sauna{at}fda.hhs.gov (Z.E.S.); kplm{at}novonordisk.com (K.L.)

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