进一步加速生物制剂的开发从DNA到IND:从COVID-19到非COVID-19计划的旅程
Kee Wee Tan1, Pengfei Ji1, Hang Zhou2
1Cell Line Development, WuXi Biologics, 288 Fute Zhong Road, Waigaoqiao Free Trade Zone, Shanghai 200131, China.
Antibody therapeutics
|February 19, 2024
概括
随着COVID-19的流行,治疗性抗体的开发加速了,化学,制造和控制 (CMC) 的时间从12-15个月缩短到3个月. 这些创新方法可以加速所有疾病领域的临床试验.
科学领域:
- 生物学的发展 生物学的发展
- 制药制造业 制药制造业 制药制造业
- 监管科学是一种监管科学.
背景情况:
- 由于COVID-19的流行,需要快速开发治疗性抗体.
- 化学,制造和控制 (CMC) 的传统时间表很长,通常为12-15个月.
- 加快开发对于患者及时获得新疗法至关重要.
研究的目的:
- 审查治疗性COVID-19抗体的加速方法.
- 讨论这些方法的适用性,以实现≤10个月的研究新药 (IND) 时间表.
- 评估这些加速方法在非COVID-19项目中更广泛应用的潜力.
主要方法:
- 对COVID-19抗体开发的已公布加速策略的审查.
- 对CMC工艺开发和制造活动的分析.
- 在WuXi Biologics对60多个COVID-19和非COVID-19计划的案例研究评估.
主要成果:
- 在使用非克隆材料的情况下,CMC时间表从12-15个月大幅缩短到大约3个月.
- 在实现加速研究新药 (IND) 时间表方面取得了成功.
- 在COVID-19和非COVID-19项目中成功应用加速方法.
结论:
- 在COVID-19大流行期间开发的创新方法可以大幅缩短药物开发时间表.
- 加快的CMC流程确保产品质量和一致性.
- 这些策略有望加速跨不同治疗领域的临床试验,从而使患者更快地获得药物.
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