CLEAR
We excel at the highly specialized process of developing monoclonal antibodies, scaling up the optimal cell line in large-scale bioreactors, and checking and rechecking for batch-to-batch consistency.1,2
Our biologic medicines are manufactured using living cells engineered to produce therapeutic proteins in large quantities. These cells are very sensitive to conditions during their synthesis and handling, and a series of culturing and purification steps are required to produce a consistent, quality active ingredient.3
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/media/135612/download. 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.
