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导航生物制药释放和稳定性监测蛋白质聚合物的非典型平衡动态
Yiting Zhang1, Ruojia Li2, Hangtian Song2
1Biologics Development, Global Product Development and Supply, Bristol Myers Squibb, MA, USA.
概括
开发一种强大的尺寸排除色谱 (SEC) 方法来量化生物制药中的高分子量 (HMW) 物种至关重要. 这项研究解决了由于缓慢,可逆动力学的HMW量化方面的挑战,确保了准确的质量控制.
科学领域:
- 生物制药的发展.
- 分析化学是一种分析化学.
- 蛋白质聚合蛋白质的聚合.
背景情况:
- 高分子量 (HMW) 物种是生物制药的关键质量属性,影响有效性和安全性.
- 准确量化HMW对于药物开发和制造质量控制至关重要.
- 由于复杂的HMW动力学,现有的方法面临挑战.
研究的目的:
- 开发一种强大的尺寸排除色谱 (SEC) 方法,用于在Fc融合蛋白治疗中量化HMW物种 (FC1).
- 研究和建模HMW形成和解离的"部分可逆"动力学.
- 为了确保准确的HMW量化质量控制释放和稳定性测试.
主要方法:
- 开发和验证一个尺寸排除色谱 (SEC) 方法.
- 对HMW平衡动力学的数学建模.
- 分析受时间,温度,度和配方影响的HMW动力学.
主要成果:
- 观察到独特的"部分可逆"HMW动力学与缓慢解离 (天).
- 在HMW量化中鉴定出由于动态行为的显著变化 (高达数量级).
- 成功开发和验证了一种强大的SEC方法,用于计算HMW动力学.
结论:
- 对HMW动力学的数学建模使得可靠的SEC量化方法的开发成为可能.
- 经过验证的方法在药物释放和稳定性质量控制中实施.
- 控制蛋白质聚合动态对于生物制药过程优化和产品释放至关重要.
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