原始集装箱关闭系统在组合产品开发中的经济优势:经过专家验证的场景和行业量化的成本和时间节省
Mehul Desai1, Daniel Waites2, William Rich3
1Enable Injections, Inc., Cincinnati, OH mdesai@enableinjections.com.
PDA journal of pharmaceutical science and technology
|June 16, 2025
概括
使用原始容器关闭系统 (CCS) 进行机身配送系统 (OBDS) 显著减少了开发时间,成本和风险. 这样可以避免漫长的兼容性和稳定性测试,加速组合产品的推出.
科学领域:
- 制药发展 制药发展
- 药物输送系统 药物输送系统
- 产品组合 产品组合
背景情况:
- 用于皮下 (SC) 输送的体内输送系统 (OBDS) 通常需要对初级容器关闭系统 (CCS) 进行更改.
- 修改CCS需要进行广泛的兼容性和稳定性测试,增加开发时间表和成本.
- 探索新的CCS引入了风险,可能会推迟产品发布.
研究的目的:
- 评估在车载配送系统 (OBDS) 开发中使用原始和新型初级容器封闭系统 (CCS) 的影响.
- 量化新型CCS的兼容性和稳定性测试所需的时间,成本和风险.
主要方法:
- 对21名美国联合产品专家进行了一项双盲在线调查.
- 该调查收集了有关兼容性问题,稳定性测试挑战的数据,并估计了与使用原始CCS相关的时间和成本节省.
主要成果:
- 11.9%的产品在新的CCS和药物之间遇到了兼容性问题,颗粒物问题是最常见的 (55.6%).
- 76.2%的专家发现,使用原始CCS可以节省12-24个月的开发时间.
- 80.9%的人报告说,CCS资格延迟了临床试验或商业推出,平均9.7个月.
结论:
- 在车体内配送系统 (OBDS) 开发中使用原始容器关闭系统 (CCS) 提供了巨大的经济效益.
- 坚持原来的CCS简化了开发过程,减轻了风险,加快了组合产品的进入市场.
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