在预装注射器中注射治疗性蛋白质的不可见颗粒的控制策略,使用流量成像
Bin Zhang1, Katiria Flores1, Nathyn Horvath1
1Injectable Drug Product Development, Alexion, AstraZeneca Rare Disease, 101 College St, New Haven, Connecticut 06510, USA.
Journal of pharmaceutical sciences
|January 18, 2026
概括
预装注射器中的油颗粒可以被标准方法误算. 微流成像为准确的可见微粒特征提供解决方案,提高药物安全性.
科学领域:
- 制药科学 制药科学
- 分析化学 分析化学
- 生物技术是生物技术.
背景情况:
- 预填注射器 (PFS) 使用油 (SiO) 滑,这可能导致药物产品中可见微粒 (SVP) 污染.
- 较高的SVP水平对满足药物库标准 (例如,USP <788>) 构成挑战,并引发了对免疫性和毒性的担忧.
- 目前的综合方法,如光遮蔽 (LO),无法区分SiO SVP和蛋白质 SVP.
研究的目的:
- 建议和验证使用微流成像 (MFI) 的预填注射器 (PFS) 的可见微粒 (SVP) 控制策略.
- 为了证明MFI在区分油 (SiO) 颗粒与蛋白质颗粒方面的能力.
- 为提高药物质量和安全,建立一种用于加强PFS产品中SVP特征的方法.
主要方法:
- 使用微流成像 (MFI) 来测量SVP数量,尺寸分布和形态.
- 在MFI中使用了形态图比 (AR) 过器 (<0.85),以区分球状SiO SVPs和纤维状/半透明蛋白质 SVPs.
- 包括FlowCam (用于粒子计数) 和拉曼显微镜 (用于SiO识别) 在内的直角技术被用于补充分析.
主要成果:
- 国际货币基金组织在检测和表征SVP方面表现出敏感性,根据形态学区分SiO颗粒和蛋白质颗粒.
- 货币金融机构方法显示稳定性指示能力,对于药物产品稳定性测试至关重要.
- 对多批蛋白X的测试证实了MFI作为开发产品特定控制策略的表征工具的有效性.
结论:
- 微流成像 (MFI) 提供了一种全面的方法,用于预填注射器 (PFS) 中可见微粒 (SVP) 的表征.
- 建议使用MFI的SVP控制策略提高了评估和控制包括油 (SiO) 在内的颗粒污染的能力.
- 这种方法支持改善药物产品质量,安全性和注射治疗药物的监管合规性.
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