药物配方专家调查的见解:高度皮下生物药物开发中的挑战和偏好
Mehul Desai1, Amitava Kundu2, Michael Hageman3
1Enable Injections, Inc., 2863 East Sharon Rd, Cincinnati, Ohio, 45241, USA. mdesai@enableinjections.com.
The AAPS journal
|September 11, 2025
概括
将静脉注射 (IV) 生物药物过渡到皮下 (SC) 输送是具有挑战性的. 专家们更喜欢使用诸如机身传递系统 (OBDS) 等设备来维持低度,而不是高度的SC配方,以减少风险和成本.
科学领域:
- 生物制药的发展.
- 药物配方科学 药物配方科学
- 皮下药物输送方式 皮下药物输送方式
背景情况:
- 从静脉注射 (IV) 对应物中开发高度皮下 (SC) 生物配方存在重大挑战.
- 这些挑战会影响配方体积,粘度和稳定性,影响药物输送和患者的治疗.
研究的目的:
- 收集药物配方专家对 IV 生物配方向 SC 输送过渡的挑战和首选方法的见解.
- 了解专家对高度SC生物制剂的配方量和开发策略的看法.
主要方法:
- 进行了一项在线调查,100名生物技术和制药行业专家熟悉高度 (≥100毫克/毫升) 的SC生物配方.
- 专家们对IV到SC配方过渡的七种方法进行了排名,重点关注度变化,容器修改和输送系统.
主要成果:
- 增加用于SC输送的药物度被认为比使用维持度的体内输送系统 (OBDS) 更有风险,更耗时,更昂贵.
- 主要的配方挑战包括溶解度 (75%),粘度 (72%) 和聚合 (68%).
- 69%的受访者报告说,由于高度SC配方问题,临床试验或产品推出延迟,加权平均延迟为11.3个月.
结论:
- 在将IV生物制剂转换为SC配方时,尽量减少度变化,可以减少开发风险,时间和成本.
- 需要在开发低度,大容量的SC配方方面进行进一步的教育,使用SC输注或OBDS等先进的输送系统.
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