生物制药
关键质量属性
设计质量
过程分析技术
生化工程
工艺工程
制造工艺
制造工程
质量(理念)
新兴技术
生物过程
医药制造业
过程(计算)
生产(经济)
资本投资
生物技术
计算机科学
风险分析(工程)
业务
工程类
下游(制造业)
运营管理
材料科学
医学
人工智能
复合材料
经济
宏观经济学
哲学
操作系统
认识论
药理学
生物
化学工程
财务
作者
Ashutosh Sharma,Dikshitkumar Khamar,Sean P. Cullen,Ambrose Hayden,Helen Hughes
标识
DOI:10.1016/j.ijpharm.2021.121115
摘要
In the past two decades, biopharmaceuticals have been a breakthrough in improving the quality of lives of patients with various cancers, autoimmune, genetic disorders etc. With the growing demand of biopharmaceuticals, the need for reducing manufacturing costs is essential without compromising on the safety, quality, and efficacy of products. Batch Freeze-drying is the primary commercial means of manufacturing solid biopharmaceuticals. However, Freeze-drying is an economically unfriendly means of production with long production cycles, high energy consumption and heavy capital investment, resulting in high overall costs. This review compiles some potential, innovative drying technologies that have not gained popularity for manufacturing parenteral biopharmaceuticals. Some of these technologies such as Spin-freeze-drying, Spray-drying, Lynfinity® Technology etc. offer a paradigm shift towards continuous manufacturing, whereas PRINT® Technology and MicroglassificationTM allow controlled dry particle characteristics. Also, some of these drying technologies can be easily scaled-up with reduced requirement for different validation processes. The inclusion of Process Analytical Technology (PAT) and offline characterization techniques in tandem can provide additional information on the Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) during biopharmaceutical processing. These processing technologies can be envisaged to increase the manufacturing capacity for biopharmaceutical products at reduced costs.
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