工艺质量强度 (PMI):对当前制造工艺的整体分析,为合成的可持续性提供信息
Ivy Kekessie1, Katarzyna Wegner2, Isamir Martinez3
1Early Discovery Biochemistry - Peptide Therapeutics, Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, California 94080, United States.
The Journal of organic chemistry
|March 20, 2024
概括
治疗性制造,主要使用固相合成 (SPPS),具有很高的环境影响,工艺质量强度 (PMI) 约为13,000. 这项研究评估了40个过程的PMI,揭示了对更绿色合成方法的需求.
科学领域:
- 制药化学 制药化学 制药化学
- 绿色化学 绿色化学
- 生物技术是生物技术.
背景情况:
- 小分子药物主导着FDA的批准,但许多目标需要替代疗法.
- 基于的治疗方法提供生物相容性和多功能性,最近的进展提高了它们的吸引力.
- 目前的酸制造严重依赖固相酸合成 (SPPS),由于大量使用溶剂和试剂,这引发了环境问题.
研究的目的:
- 通过编制工艺质量强度 (PMI) 指标来评估合成制造对环境的影响.
- 为了比较合成的可持续性与其他药物模式,如小分子和生物制药.
- 确定制造业需要改进的领域,以减少其环境足迹.
主要方法:
- 收集和分析了来自40个合成制造工艺的工艺质量强度 (PMI) 数据,跨越各种开发阶段.
- 根据制药产品的开发阶段分类PMI评估.
- 按制造阶段分类的PMI:合成,净化和隔离.
主要成果:
- 固相合成 (SPPS) 的高平均PMI约为13,000.
- 与小分子药物 (中位数PMI 168-308) 和生物制药 (PMI ≈ 8300) 相比,合成PMI显著更高.
- 这项综合性评估是迄今为止对合成制造业环境指标的最广泛评估.
结论:
- 与当前的制造方法相关的高PMI需要开发更环保的可持续工艺.
- 类疗法虽然有希望,但需要更绿色的制造策略,以符合可持续发展目标.
- 对合成技术的进一步研究和创新对于减少环境影响至关重要.
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