研究制造方法对基于蛋白质的长效注射配方的影响:微流体与微流体的比较评估. 传统方法 传统方法
Nihan Yonet-Tanyeri1, Robert S Parker1,2,3, Louis D Falo2,4,5,6
1Department of Chemical Engineering, University of Pittsburgh, 940 Benedum Hall, 3700 O'Hara Street, Pittsburgh, PA 15213, USA.
Pharmaceutics
|October 26, 2024
概括
微流体制造与传统方法相比,可以更好地控制含蛋白质的微粒质量属性和批量一致性,这对于有效的药物输送至关重要.
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:
- 微粒子药物输送系统增强了基于蛋白质的配方,以改善患者的服药性和治疗结果.
- 通过微流体的连续制造越来越多地用于药物封装微粒,但蛋白质药物的比较数据有限.
- 这项研究解决了对带有蛋白质的微粒进行批量对微流体学方法比较评估的需要.
研究的目的:
- 通过使用传统批量和微流体方法生成免疫调节蛋白药物载荷的注射配方.
- 通过每种方法比较评估每种方法产生的微粒的关键质量属性.
- 为了评估蛋白质载荷微粒制造中的批量变化.
主要方法:
- 准备复合的人类C-C基因化学基因连接体22 (rhCCL22) 载荷的聚乳-同-甘油酸 (PLGA) 微粒.
- 利用传统的同质化和微流体制造技术.
- 对微粒子大小,大小分布,形态,封装效率和释放动力学的比较分析.
主要成果:
- 与传统方法相比,微流体学方法产生了尺寸分布较窄的微粒,表面孔径较小的微粒.
- 在两种制造方法之间观察到药物释放动力学的显著差异.
- 微流体学方法表明,对含蛋白质的微粒的批量变化最小.
结论:
- 制造方法显著影响蛋白质载荷微粒的关键质量属性.
- 微流体技术为生产高质量的含蛋白质的微粒提供了更好的控制和一致性.
- 对比评估对于确保药物配方制造的有效性,监管合规性和质量控制至关重要.
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