化-曼尼托尔-蛋白质基产品的配方和冷化过程的策略
Chenying Lin1, Xiaozhang Zhang1, Chunsheng Yang1
1Drug Product Development, WuXi Biologics (Shanghai) Co., Ltd., Shanghai, China.
Journal of pharmaceutical sciences
|February 28, 2025
概括
本研究探讨了含有化 (NaCl) 和曼尼托的蛋白质配方的最佳冷凍化策略. 研究结果揭示了改善蛋糕外观和稳定性的方法,这对于生物制药发展至关重要.
科学领域:
- 制药科学 制药科学
- 生物技术是生物技术.
- 材料科学 材料科学 材料科学
背景情况:
- 化 (NaCl) 稳定蛋白质,但具有较低的溶解点,有可能使冷解产品崩.
- 曼尼托尔是一种充填剂,具有高温点,提供机械支,但可以与NaCl产生不利的相互作用.
- 结合NaCl和曼尼托尔的配方在冷化过程中经常因不适当的比例或过程而崩.
研究的目的:
- 研究用于改善含有NaCl和曼尼托尔的蛋白质配方的冷解蛋糕外观的策略.
- 确定合适的配方成分和冷化过程参数,以提高稳定性和外观.
- 了解NaCl-曼尼托尔蛋白系统的结晶行为.
主要方法:
- 探索配方成分和冷化过程参数.
- 对冷解蛋糕外观和蛋白质稳定性的分析.
- 用X射线衍射 (XRD) 研究结晶行为和曼尼托尔晶体形式.
主要成果:
- 提出了合适的冷化配方成分和工艺参数,产生可接受的蛋白质稳定性和改善蛋糕外观.
- 观察到NaCl和曼尼托结晶的相互抑制,通过XRD识别了各种曼尼托结晶形式.
- 发现蛋白质度和冷化参数显著影响曼尼托尔晶体形式.
结论:
- 确定了改善NaCl-曼尼托尔蛋白配方中的冷解生物制药外观的策略.
- 对结晶行为的洞察力为优化冷化过程提供了基础.
- 这些发现有助于在药物开发中更广泛地应用这些配方.
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