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合同开发和制造组织的选择:关键考虑因素,可以使或破坏您的细胞和基因疗法开发
Maryam A Pasdar1, Mitchel M Sivilotti2, Peter S Jaehn3
1Children's National Hospital, Washington, DC, USA.
Cytotherapy
|March 26, 2024
概括
选择合适的合同开发和制造组织 (CDMO) 对细胞和基因疗法 (CGT) 公司至关重要. 本分析强调了在CGT产品开发中成功建立CDMO合作伙伴关系的关键因素.
科学领域:
- 生物技术是生物技术.
- 制药科学 制药科学
- 监管事务 监管事务
背景情况:
- 细胞和基因疗法 (CGT) 临床试验的不断扩大,导致合同开发和制造组织 (CDMO) 的增加.
- 由于有限的内部专业知识,小型生物技术公司在选择和将流程转移到CDMO时经常遇到挑战.
- 产品的成功商业化在很大程度上取决于选择合适的CDMO.
研究的目的:
- 分析在CGT开发中选择和与CDMO合作的关键考虑因素.
- 为CGT公司提供有关技术专业知识,风险共享和合作伙伴关系时间的见解.
- 详细介绍使用CDMO导航CGT产品开发所必需的因素.
主要方法:
- 在巴黎举行的2023年国际细胞和基因治疗学会会议上,CGT开发人员和CDMO代表参加了圆桌讨论.
- 讨论了产品开发的关键方面,包括技术能力,风险分配和合作的战略时间.
- 专家小组的见解作为进一步分析的基础.
主要成果:
- 讨论确定了技术专业知识是选择CDMO的主要因素.
- 风险共享模式和与CDMO接触的时机成为了关键的讨论点.
- 专家小组强调了调整CGT开发商和CDMO之间的期望的重要性.
结论:
- 对于CGT产品从开发到商业化成功过渡,CDMO的战略选择至关重要.
- 在CDMO伙伴关系中,应对与专业知识,风险和时间相关的挑战对CGT公司至关重要.
- 对这些因素的进一步阐述将有助于CGT开发商优化其外包战略.
关键词:
细胞制造业 细胞制造业在商业化,商业化.发展过程发展过程.技术转让技术转让技术转让技术转让技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移技术转移
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