target="_blank" rel="nofollow" href="https://doi.org/10.1007/978-3-642-41199-1_1">https://doi.org/10.1007/978‐3‐642‐41199‐1_1. Heidelberg: Springer‐Verlag https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4513659 (accessed 24 September 2019).12 12 Bren, L. (2006). The road to the biotech revolution – highlights of 100 years of biologics regulation. FDA Consumer magazine, Centennial Edition (January–February). https://www.fda.gov/files/about%20fda/published/The‐Road‐to‐the‐Biotech‐Revolution‐‐Highlights‐of‐100‐Years‐of‐Biologics‐Regulation.pdf (accessed 24 September 2019).
13 13 Chiu, M. and Gilliland, G. (2016). Engineering antibody therapeutics. Current Opinion in Structural Biology 38: 163–173. https://www.sciencedirect.com/science/article/pii/S0959440X16300872?via%3Dihub (accessed 24 September 2019).
14 14 Safary, A., Akbarzadeh Khiavi, M., Mousavi, R. et al. (2018). Enzyme replacement therapies: what is the best option? BioImpacts: BI 8 (3): 153–157. https://doi.org/10.15171/bi.2018.17, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6128977 (accessed 24 September 2019).
15 15 Ozaki, K. and Leonard, W.J. (2002). Cytokine and cytokine receptor pleiotropy and redundancy. The Journal of Biological Chemistry 277: 29355–29358. http://www.jbc.org/content/277/33/29355.full.html#fn‐1 (accessed 24 September 2019).
16 16 Rider, P., Carmi, Y., and Cohen, I. (2016. https://doi.org/10.1155/2016/9259646). Biologics for targeting inflammatory cytokines, clinical uses, and limitations. International Journal of Cell Biology 2016: 9259646, 11 pp. https://www.hindawi.com/journals/ijcb/2016/9259646/cta (accessed 24 September 2019).
17 17 DailyMed [Internet] (2005). Bethesda, MD: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed (accessed 18 May 2018). Drug labeling on this Web site is as submitted to the Food and Drug Administration (FDA).
18 18 Gutterman, J.U. (1994). Cytokine therapeutics: lessons from interferon alpha. Proceedings of the National Academy of Sciences of the United States of America 91 (4): 1198–1205. https://doi.org/10.1073/pnas.91.4.1198, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC43124 (accessed 24 September 2019).
19 19 Saleem, S., Anwar, A., Fayyaz, M. et al. (2019). An overview of therapeutic options in relapsing‐remitting multiple sclerosis. Cureus 11 (7): e5246. https://doi.org/10.7759/cureus.5246, https://www.cureus.com/articles/21600‐an‐overview‐of‐therapeutic‐options‐in‐relapsing‐remitting‐multiple‐sclerosis (accessed 24 September 2019).
20 20 Akdis, M., Aab, A., Altunbulakli, C. et al. Interleukins (from IL‐1 to IL‐38), interferons, transforming growth factor β, and TNF‐α: receptors, functions, and roles in diseases. Journal of Allergy and Clinical Immunology 138 (4): 984–1010. https://www.jacionline.org/article/S0091‐6749(16)30715‐1/fulltext (accessed 24 September 2019).
21 21 Lis, K., Kuzawińska, O., and Bałkowiec‐Iskra, E. (2014). Tumor necrosis factor inhibitors – state of knowledge. Archives of Medical Science, AMS 10 (6): 1175–1185. https://doi.org/10.5114/aoms.2014.47827, https://www.ncbi.nlm.nih.gov/pubmed/25624856 (accessed 24 September 2019).
22 22 Diabetes.co.uk. History of insulin. Diabetes Digital Media Ltd. https://www.diabetes.co.uk/insulin/history‐of‐insulin.html (accessed 24 September 2019).
23 23 Swiech, K., Picanço‐Castro, V., and Covas, D.T. (2017). Production of recombinant coagulation factors: are humans the best host cells? Bioengineered 8 (5): 462–470. https://doi.org/10.1080/21655979.2017.1279767, https://www.tandfonline.com/doi/full/10.1080/21655979.2017.1279767 (accessed 24 September 2019).
24 24 Stryjewska, A., Kiepura, K., Librowski, T., and Lochynski, S. (2013). Biotechnology and genetic engineering in the new drug development. Part I. DNA technology and recombinant proteins. Pharmacological Reports 65 (5): 1075–1085. http://www.if‐pan.krakow.pl/pjp/pdf/2013/5_1075.pdf (accessed 24 September 2019).
25 25 Lodish, H., Berk, A., Zipursky, S.L. et al. (2000). Section 7.1, DNA cloning with plasmid vectors. In: Molecular Cell Biology, 4e. New York: W. H. Freeman https://www.ncbi.nlm.nih.gov/books/NBK21498 (accessed 24 September 2019).
26 26 Jayapal, K., Wlaschin, K., Hu, W., and Yap, M. Recombinant Protein Therapeutics from CHO Cells – 20 Years and Counting. CHO Consortium, SBE Special Section https://pdfs.semanticscholar.org/5f96/12ce9170571f296b75246e80cb671bbb886c.pdf (accessed 24 September 2019).
27 27 Lundstrom, K. (2018). Viral vectors in gene therapy. Diseases (Basel, Switzerland) 6 (2): 42. https://doi.org/10.3390/diseases6020042, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6023384 (accessed 24 September 2019).
28 28 Hersom, M. and Jorgensen, J.T. (2018). Companion and complementary diagnostics‐focus on PD‐L1 expression assays for PD‐1/PD‐L1 checkpoint inhibitors in non‐small cell lung cancer. Therapeutic Drug Monitoring 40 (1): 9–16. https://www.ncbi.nlm.nih.gov/pubmed/29084031. (accessed 24 September 2019).
29 29 Bernicker, E.H., Allen, T.C., and Cagle, P.T. (2019). Update on emerging biomarkers in lung cancer. Journal of Thoracic Disease 11 (Suppl 1): S81–S88. https://doi.org/10.21037/jtd.2019.01.46, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6353743/#r36 (accessed 24 September 2019).
30 30 Keytruda® [package insert] (September 2019). Whitehouse Station, NJ: Merck Sharp & Dohme Corp.. https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf (accessed 24 September 2019).
31 31 U.S. Food and Drug Administration (2018). Industry information
