大规模结晶作为胰岛素下游过程中的中间加工步骤:探索了优势,并确定了工艺强化工具.
Partha Hazra1, Madhavan Buddha2, Chinnappa Reddy2
1Biocon Biologics Limited (BBL), Biocon Research Center (BRC), Biocon Park, Plot No. 2 & 3, Bommasandra Industrial Estate, IV Phase, Bommasandra Jigani Link Road, Bangalore, 560 099, India. Partha.Hazra@biocon.com.
Bioprocess and biosystems engineering
|November 8, 2023
概括
提高胰岛素生产效率至关重要,因为糖尿病率不断上升. 这项研究探讨了化沉以提高纯度和降低胰岛素制造成本,为昂贵的染色学提供了可行的替代方案.
科学领域:
- 生物制药制造业 生物制药制造业
- 化学工程是化学工程的重要组成部分.
- 过程强化 过程强化
背景情况:
- 全球糖尿病患病率需要增加胰岛素的可获得性和可负担性.
- 下游加工是大批量生物制药制造中常见的瓶.
- 过程集成和强化是提高效率和降低生产成本的关键.
研究的目的:
- 探索依赖pH值的-胰岛素复合体形成,以改善制造.
- 评估化沉/结晶作为一种具有成本效益的净化方法.
- 为了证明这种方法在取代昂贵的捕获色谱步骤方面的潜力.
主要方法:
- 研究了胰岛素在形成pH依赖的-胰岛素复合物的特性.
- 使用化沉/结晶作为一个单元操作.
- 评估了对产品纯度和杂质减少的影响.
- 评估了工艺量,缓冲器消耗和设备足迹的变化.
主要成果:
- 化沉/结晶显著提高了工艺中的产品纯度.
- 观察到产品和工艺相关杂质的减少.
- 该方法显示了替代高成本捕获色谱的潜力.
- 在运营量,缓冲区使用量和设备足迹上有明显的减少.
结论:
- 化沉是一种高效且具有成本效益的单元操作,用于胰岛素净化.
- 这种方法提供了显著的制造灵活性和成本节省.
- 这些发现支持胰岛素和生物类似药制造商寻求具有成本效益的生产更广泛采用.
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