设计中的可持续性用于重组蛋白疗法
Renato Mastrangeli1, Maria Concetta Audino1, Steve Marquis Fernandes2
1Global CMC Development, CMC Science & Intelligence, Merck Serono S.p.A. (an affiliate of Merck KGaA, Darmstadt, Germany), Guidonia Montecelio, Rome, Italy.
Drug discovery today
|June 6, 2025
概括
开发可持续的重组蛋白疗法需要将化合物设计与过程优化整合起来. 这种方法尽量减少浪费,降低成本,并扩大获得创新药物的机会,这对于未来的生物治疗竞争力至关重要.
科学领域:
- 药理学和生物治疗学
- 可持续制造 可持续制造 可持续制造
- 药物开发 药物开发
背景情况:
- 重组蛋白疗法在现代医学中至关重要,但面临着重大可持续性挑战.
- 高消耗率,资源密集型生产和复杂的供应链导致浪费,排放和成本上升.
- 对可持续性和基于价值的医疗保健的监管重视越来越大,加剧了这些发展障碍.
研究的目的:
- 提出一项全面的战略,以提高重组蛋白治疗开发的可持续性.
- 强调将复合设计原则纳入可持续发展努力的重要性.
- 确定最大限度地提高生物治疗药物的可持续性概况的关键标准.
主要方法:
- 分析生物治疗开发当前的可持续性挑战.
- 关键化合物设计特征的识别 (例如分子格式,半衰期,稳定性).
- 对表达主机效率和可开发性评估的评估.
主要成果:
- 仅仅优化流程是不够的;整合复合设计是可持续性的关键.
- 简单的分子格式,延长半衰期和增强的稳定性减少环境影响和成本.
- 提高表达主机效率和严格的开发能力评估进一步促进了可持续性.
结论:
- 结合过程优化和智能化合物设计的整体方法对于可持续的生物治疗发展至关重要.
- 增强的可持续性概况将提高未来生物治疗药物的竞争力.
- 可持续实践与全球卫生目标保持一致,包括联合国可持续发展目标,通过改善医药的可访问性.
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