Anouk Donners

40 Chapter 2 REFERENCES 1. European Medicines Agency. European public assessment reports. Table of all EPARs for human and veterinary medicines. https://www.ema.europa.eu/en/medicines/download-medicine-data#europeanpublic-assessment-reports-(epar)-section. Accessed on 25-08-2018. 2. Elvin JG, Couston RG, van der Walle CF. Therapeutic antibodies: market considerations, disease targets and bioprocessing. Int J Pharm. 2013; 440: 83-98. 3. Imai K, Takaoka A. Comparing antibody and small-molecule therapies for cancer. Nat Rev Cancer. 2006; 6: 714-727. 4. Ryman JT, Meibohm B. Pharmacokinetics of Monoclonal Antibodies. CPT Pharmacometrics Syst Pharmacol. 2017; 6: 576-588. 5. Kohler G, Milstein C. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature. 1975; 256: 495-497. 6. Taylor LD, Carmack CE, Huszar D, Higgins KM, Mashayekh R, Sequar G, Schramm SR, Kuo CC, Odonnell SL, Kay RM, Woodhouse CS, Lonberg N. Human-Immunoglobulin Transgenes Undergo Rearrangement, Somatic Mutation and Class Switching in Mice That Lack Endogenous Igm. Int Immunol. 1994; 6: 579-591. 7. Green LL, Hardy MC, Maynardcurrie CE, Tsuda H, Louie DM, Mendez MJ, Abderrahim H, Noguchi M, Smith DH, Zeng Y, David NE, Sasai H, Garza D, Brenner DG, Hales JF, Mcguinness RP, Capon DJ, Klapholz S, Jakobovits A. Antigen-Specific Human Monoclonal-Antibodies from Mice Engineered with Human Ig Heavy and Light-Chain Yacs. Nat Genet. 1994; 7: 13-21. 8. Morrison SL, Johnson MJ, Herzenberg LA, Oi VT. Chimeric human antibody molecules: mouse antigenbinding domains with human constant region domains. Proc Natl Acad Sci U S A. 1984; 81: 6851-6855. 9. Riechmann L, Clark M, Waldmann H, Winter G. Reshaping human antibodies for therapy. Nature. 1988; 332: 323-327. 10. Pineda C, Castaneda Hernandez G, Jacobs IA, Alvarez DF, Carini C. Assessing the Immunogenicity of Biopharmaceuticals. BioDrugs. 2016; 30: 195-206. 11. Warnke C, Hermanrud C, Lundkvist M, Fogdell-Hahn A. Anti-drug antibodies. Drugs and Therapy Studies. 2012; 2: 11. 12. Schellekens H. The immunogenicity of therapeutic proteins. Discov Med. 2010; 9: 560-564. 13. European Medicines Agency. Development pharmaceutics - Scientific guideline. (CPMP/BWP/328/99). Annex to note for guidance on development of pharmaceutics (CPMP/QWP/155/96), 1998. http:// www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003603. pdf. Accessed on 22-11-2017. 14. US Food and Drug Administration. Immunogenicity Assessment for Therapeutic Protein Products, Guidance for Industry, 2014. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/ guidances/ucm338856.pdf. Accessed on 28-03-2017. 15. World Health Organization. Guidelines on the quality, safety, and efficacy of biotherapeutic protein products prepared by recombinant DNA technology, 2013. http://www.who.int/biologicals/ biotherapeutics/rDNA_DB_final_19_Nov_2013.pdf. Accessed on 28-03-2017. 16. Nowatzke WL, Rogers K, Wells E, Bowsher RR, Ray C, Unger S. Unique challenges of providing bioanalytical support for biological therapeutic pharmacokinetic programs. Bioanalysis. 2011; 3: 509-521.

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