Mizukami Amanda, Caron Angelo Luis, Picanço-Castro Virgínia, Swiech Kamilla
Center for Cell-based Therapy CTC, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.
School of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo, Ribeirão Preto, Brazil.
Methods Mol Biol. 2018;1674:1-14. doi: 10.1007/978-1-4939-7312-5_1.
The majority of FDA-approved biology-derived products are recombinant glycoproteins. These proteins have been used for the treatment of several diseases, with numerous products currently approved for clinical use. The choice of the expression system is a key step toward a successful functional protein production, since glycosylation influences yield, pharmacokinetics, biological activity, and immunogenicity. This chapter covers the general aspects of therapeutic recombinant glycoproteins and the platforms that are being employed for their production.
大多数获得美国食品药品监督管理局(FDA)批准的生物衍生产品都是重组糖蛋白。这些蛋白质已被用于治疗多种疾病,目前有众多产品获批用于临床。表达系统的选择是成功生产功能性蛋白质的关键步骤,因为糖基化会影响产量、药代动力学、生物活性和免疫原性。本章涵盖治疗性重组糖蛋白的一般方面以及用于其生产的平台。