Upstream Development, Alexion Pharmaceuticals, Cheshire, CT, 06410, USA,
Adv Biochem Eng Biotechnol. 2014;139:1-9. doi: 10.1007/10_2013_255.
Biopharmaceuticals represent a growing sector of the pharmaceutical industry, and are used for a wide range of indications, including oncology and rheumatology. Cultured mammalian cells have become the predominant expression system for their production, partly due to their ability to complete the posttranslational modifications required for drug safety and efficacy. Over the past decade, the productivity of mammalian cell culture production processes has growth dramatically through improvements in both volumetric and specific productivities. This article presents an overview of the biologics market, including analysis of sales and approvals; as well as a review of industrial production cell lines and cell culture operations.
生物制药是医药行业不断发展的一个领域,广泛用于各种适应症,包括肿瘤学和风湿病学。由于能够完成药物安全性和疗效所需的翻译后修饰,因此培养的哺乳动物细胞已成为其生产的主要表达系统。在过去的十年中,通过提高体积产率和比产率,哺乳动物细胞培养生产工艺的生产力得到了显著提高。本文概述了生物制药市场,包括对销售额和批准情况的分析;以及对工业生产细胞系和细胞培养操作的回顾。