Novel strategies for the purification of monoclonal antibodies

A. Azevedo, M. Aires-Barros
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引用次数: 1

Abstract

Following the success of therapeutic recombinant proteins, monoclonal antibodies (mAbs) represent the second outbreak of innovation created by the biotechnology industry. With more than 25 products in clinical use worldwide, including eight blockbuster drugs, mAbs remain one of the most exciting and promising areas within the world pharmaceutical market, with a global share worth $55 billion in 2010. The greatest capacity constraints in current manufacturing platforms are no longer found in the upstream production processes, where cell culture productivity has dramatically increased over the past decade, but in the downstream purification area. Challenges in the purification of mAbs include reducing production costs, developing robust purification processes and integrating upstream and downstream processes. Although packed-bed chromatography is the workhorse in the downstream processing of therapeutic mAbs, limitations are observed at the very large-scale and therefore additional options are needed to increase the manufacturing capacity and decrease the cost of goods.
单克隆抗体纯化的新策略
继治疗性重组蛋白的成功之后,单克隆抗体(mab)代表了生物技术行业创造的第二次创新爆发。在全球范围内,有超过25种产品在临床使用,其中包括8种重磅药物,单克隆抗体仍然是世界制药市场中最令人兴奋和最有前途的领域之一,2010年全球市场份额为550亿美元。当前制造平台最大的产能限制不再出现在上游生产过程中,在过去十年中,细胞培养生产率大幅提高,而是出现在下游净化领域。mab纯化的挑战包括降低生产成本,开发强大的纯化工艺以及整合上游和下游工艺。虽然填充床色谱是治疗性单克隆抗体下游加工的主力,但在非常大规模的情况下观察到局限性,因此需要额外的选择来提高生产能力并降低商品成本。
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