生產程序
CLEAR

生產程序

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嚴謹的生產程序

我們精於應用製造生物製劑的專業化程序,包括研發單克隆抗體、在生物反應器中大量生產細胞,以及反覆檢查,確保每個批次的一致性。1,2

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以活細胞製造藥物

我們的生物製劑是由經過基因工程處理的活細胞所製造,能夠大量生產治療性蛋白。這些細胞在合成的過程中對環境非常敏感,並且需要進行一系列培養和純化步驟,才能製造出穩定而優質的有效成份。3

cell group cell group

References: 1. Desanvicente-Celis Z, Gomez-Lopez A, Anaya JM. Similar biotherapeutic products: overview and reflections. Immunotherapy. 2012;4:1841-1857. 2. Ramanan S, Grampp G. Drift, evolution, and divergence in biologics and biosimilars manufacturing. BioDrugs. 2014;28:363-372. 3. Lybecker KM. The biologics revolution in the production of drugs. Fraser Institute. www.fraserinstitute.org/studies/biologics-revolution-in-the-production-of-drugs. Accessed April 8, 2020. 4. Dranitsaris G, Amir E, Dorward K. Biosimilars of biological drug therapies. Drugs. 2011;71:1527-1536. 5. Kozlowski S. US FDA perspectives on biosimilar biological products. Presented at: 2014 Biotechnology Technology Summit; June 13, 2014; Rockville, MD. www.ibbr.umd.edu/sites/default/files/public_page/Kozlowski%20-%20Biomanufacturing%20Summit.pdf. Accessed April 8, 2019. 6. US Food and Drug Administration. Guidance for industry: quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product. www.fda.gov/downloads/drugs/guidances/ucm291134.pdf. Accessed April 8, 2020. 7. Liu HF, Ma J, Winter C, Bayer R. Recovery and purification process development for monoclonal antibody production. mAbs. 2010;2:480-499. 8. Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol. 2008;19:411-419. 9. Roger SD. Biosimilars: how similar or dissimilar are they? Nephrology. 2006;11:341-346. 10. Hesse F, Wagner R. Developments and improvements in the manufacturing of human therapeutics with mammalian cell cultures. Trends Biotechnol. 2000;18:173-180. 11. Bee JS, Randolph TW, Carpenter JF, Bishop SM, Dimitrova MN. Effects of surfaces and leachables on the stability of biopharmaceuticals. J Pharma Sci. 2011;100:4158-4170.

HK-09630-AMGEN-2022-Dec
Date of approval: 2022年12月