| 1 | [1] Walsh, G. (2018). Biopharmaceuticals: Biochemistry and Biotechnology (3rd ed.). Wiley. |
| 2 | [2] Reichert, J. M. (2020). Trends in the development and approval of new biopharmaceuticals. Nature Reviews Drug Discovery, 19(3), 163–164. |
| 3 | [3] Ecker, D. M., Jones, S. D., & Levine, H. L. (2015). The therapeutic monoclonal antibody market. mAbs, 7(1), 9–14. |
| 4 | [4] Plotkin, S. A., Orenstein, W. A., Offit, P. A., & Edwards, K. M. (2018). Plotkin's Vaccines (7th ed.). Elsevier. |
| 5 | [5] Dunbar, C. E., et al. (2018). Gene therapy comes of age. Science, 359(6372) |
| 6 | [6] Trounson, A., & McDonald, C. (2015). Stem cell therapies in clinical trials: Progress and challenges. Cell Stem Cell, 17(1), 11–22 |
| 7 | [7] Ozturk, S. S., & Hu, W. S. (2014). Cell Culture Technology for Pharmaceutical and Cell-Based Therapies. CRC Press. |
| 8 | [8] Shukla, A. A., & Gottschalk, U. (2013). Single-use disposable technologies for biopharmaceutical manufacturing. Trends in Biotechnology, 31(3), 147–154. |
| 9 | [9] Rathore, A. S., & Winkle, H. (2009). Quality by design for biopharmaceuticals. Nature Biotechnology, 27(1), 26–34. |
| 10 | [10] European Medicines Agency (EMA). (2023). Guidelines on Biosimilars. EMA Publications. |