Evaluating the Bioequivalence of Antibody–Drug Conjugates - Pharmaceutical Technology

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Evaluating the Bioequivalence of Antibody–Drug Conjugates
The authors discuss the analytical methods and related testing for bioequivalence studies of ADCs. This article is part of a special issue on analytical technology.


Pharmaceutical Technology
pp. s22-s27

References

1. T.T. Hansel, et al., Nature Rev. Drug Discov. 9 (4), 325–338 (2010).

2. D.R. Mould and K.R.D. Sweeney, Curr. Opin. in Drug Discov. Devel. 10, (1), 84–96 (2007).

3. Genentech, "Herceptin (trastuzumab) Intravenous Infusion, Full Prescribing Information" (South San Francisco, CA), http://www.gene.com/gene/products/information/oncology/herceptin/, accessed Oct. 10, 2011.

4. G.D. Lewis Phillips et al., Cancer Res. 68 (22), 9280–9290 (2008).

5. A. Beck, Discov. Med. 10 (53), 329–339 (2010).

6. I.E. Krop et al., J. Clinical Oncology 28 (16), 2698–2704 (2010).

7. H.A. Buris et al., et al. J. Clinical Oncology 29 (4), 398–405 (2011).

8. FDA, "FDA: Pfizer Voluntarily Withdraws Cancer Treatment Mylotarg from US Market," Press Release (Rockville, MD, June 21, 2010, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm216448.htm, accessed Oct. 10, 2011.

9. EMA, Procedure No. EMEA/H/C/000705, EMEA/HMP/5130/2008 "Refusal Assessment Report for Mylotarg"(London, 2008).

10. P. Van Arnum, Pharm. Technol. 32 (6), 54–58 (2008).

11. A. Beck, T. Wurch, J.M. Reichert, Landes Biosci. 3 (2), 111–132 (2011).

12. A. Beck, P. Senter, and R. Chari, Landes Biosci. 3 (4) 331–337 (2011).

13. FDA, "Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use" (Rockville, MD, Feb. 1997).

14. F. Ehmann, presentation at the GCC Workshop on Similar Biological Medicinal Products (Riyadh, Saudi Arabia, Apr. 19–20, 2011).

15. EMA, EMA/CHMP/BMWP/86289/2010, Guideline on Immunogenicity Assessment of Monoclonal Antibodies Intended for In Vivo Clinical Use (London, 2010).

16. Biophoenix, "Biosimilars, Biogenerics and Follow-on Biologics (Informa, UK 2007), http://www.scripintelligence.com/multimedia/archive/00000/BS1342_117a.pdf accessed Oct. 10, 2011.

17. A.G. Polson et al., Blood 110 (2), 616–623 (2007).

18. K. Anderson, presentation at the National Biotechnology Conference (San Francisco, 2011).

19. R.P. Lyon et al., presentation at the 101st Annual American Association for Cancer Research Meeting (Washington DC, 2010).

20. FDA, Guidance for Industry Safety Testing of Drug Metabolites (Rockville, MD, Feb. 2008).


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