治疗性菌体的先进制造,配方和微封装
Danish J Malik1, Henrique Goncalves-Ribeiro1, Dirk GoldSchmitt2,3
1Chemical Engineering Department, Loughborough University, Loughborough, United Kingdom.
概括
制造菌体药物产品需要强大的过程控制和监测. 优化关键参数可确保稳定,高质量的产品,用于有效的菌体治疗.
科学领域:
- 生物技术是生物技术.
- 制药制造业 制药制造业 制药制造业
- 药物开发 药物开发
背景情况:
- 制造稳定,高剂量的菌体药物产品 (DPs) 用于临床使用需要改进的过程监测和控制.
- 确保产品质量需要将关键过程参数 (CPP) 对上游 (USP) 和下游 (DSP) 过程的关键质量属性 (CQA) 进行映射.
研究的目的:
- 突出过程分析技术 (PAT) 对于加强细菌制造中的监测和控制的重要性.
- 强调在菌体DPs的临床前发展中需要考虑早期的配方.
主要方法:
- 讨论一次性使用技术作为菌体生物工艺开发和药物制造 (DS) 的首选制造选项.
- 整合工艺分析技术 (PAT) 以提高工艺稳定性和生产力,从而提高菌体位.
主要成果:
- 实施PAT可以减少分批变异性,提高菌体制造中的生产率.
- 细菌体DPs在各种剂量形式的精确配方可以显著提高菌体治疗结果.
结论:
- 早期考虑配方,包括生理化学性质,辅助剂兼容性和存储稳定性,对于菌体DP的发展至关重要.
- 可扩展的制造,成本效益和监管合规性是成功开发和临床应用菌体药物产品的关键因素.
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