高剂量生物制剂的皮下注射开发路线图 - 高度配方,分析可比性和患者偏好考虑大容量器件的考虑
Indrajit Ghosh1, Daniel Miranda1, Tanmay A Kulkarni2
1Sterile Product and Device Development, Bristol Myers Squibb, 1 Squibb Drive, 08901 NJ, United States.
Journal of pharmaceutical sciences
|July 24, 2025
概括
开发用于皮下输送的高剂量生物药物需要仔细的配方和设备选择. 该审查指导产品开发,解决诸如高度和患者耐受性等挑战,以成功治疗慢性疾病.
科学领域:
- 制药科学 制药科学
- 生物技术是生物技术.
- 药物运输 药物运输 药物运输
背景情况:
- 高剂量的生物制药 (DPs) 越来越多地用于慢性疾病.
- 皮下 (SC) 自治是首选的,但呈现出发育复杂性.
- 关键的挑战包括高度配方,大容量输送装置和药理动力学 (PK) 桥梁风险.
研究的目的:
- 审查高剂量生物DP的新型配方和加工技术.
- 讨论通过体外/活体研究来尽量减少临床桥梁风险的策略.
- 为选择合适的设备方法和开发路线图提供指导.
主要方法:
- 对新型配方和加工技术的审查.
- 分析用于风险评估的体外/体生研究.
- 检查关于用户和患者偏好的案例研究.
- 讨论质量目标产品配置文件 (QTPP) 的定义.
主要成果:
- 强大的配方策略和分析特征对于产品的可比性至关重要.
- 人为因素和患者偏好研究为选择患者友好的输送设备提供了信息.
- 案例研究说明了为设备选择,剂量和开发定义QTPP.
结论:
- 克服发展挑战需要制定,设备设计和临床评估的综合战略.
- 尽量减少PK桥接风险对于成功的产品开发和推出至关重要.
- 本综述为开发用于SC的高剂量生物DP提供了指导.
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