Abstract
Animal cell culture bioprocesses based on mammalian expression systems have given the pharmaceutical industry a means to produce complex glycosylated therapeutic proteins that is projected to be at least a US$500 billion dollar market by 2020. Medicinal products produced by mammalian cell cultures include hormones, enzymes, cytokines, bone morphogenic proteins, clotting factors, antibodies, and fusion protein therapeutics. Activase®, a recombinant thrombolytic enzyme, was the first approved mammalian cell culture drug to be produced from Chinese hamster ovary cell culture and marketed to the public. Over time, other mammalian derived products followed and have evolved from simple replicas of endogenous proteins to complex engineered bio-molecules. Among the existing mammalian expressed biological drugs discussed, that have been produced in the USA and EU till early 2014, monoclonal antibody therapeutics have become the top earning products being over 40 % of products produced. The development of chimeric, humanized and eventually fully human antibodies has also decreased immunogenic reactions in human patients to below 10 % for the majority of engineered monoclonals with some even reaching below 1 %. Enbrel®, the first Fc-fusion protein introduced onto the market has also led to engineered therapeutic proteins with a longer half-life and multiple functions as with the introduction of bispecific antibody therapeutics. The introduction of the first biosimilars, starting in 2007, can further lower the cost of access to mammalian produced biologics and has also meant a further increase in the overall mammalian cell culture capacity around the globe.
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Kuystermans, D., Al-Rubeai, M. (2015). Biopharmaceutical Products from Animal Cell Culture. In: Al-Rubeai, M. (eds) Animal Cell Culture. Cell Engineering, vol 9. Springer, Cham. https://doi.org/10.1007/978-3-319-10320-4_23
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