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关于生物治疗药物的免疫性风险评估工具的调查结果:对药物开发中的方法,应用和实用性的共识的洞察

Jochem Gokemeijer¹, Yi Wen², Vibha Jawa³

¹Bristol Myers Squibb, 100 Binney Street, Cambridge, Massachusetts, 02143, USA. jochem.gokemeijer@bms.com.

The AAPS journal

|June 2, 2023

概括

制药科学家使用计算和实验室方法来预测和评估早期发展中的药物免疫性风险. 这些策略为临床决策提供了信息,并简化了制造过程.

科学领域:

制药科学制药科学
药物开发药物开发
免疫性评估的免疫性评估

背景情况:

治疗产品免疫性 (TPI) 社区调查了制药科学家关于免疫性风险评估策略.
该调查跨越了5年和两个阶段,收集了有关早期药物开发实践的数据.

研究的目的:

了解在临床开发之前使用的当前免疫性风险评估策略.
确定在风险评估中使用in silico和in vitro方法的趋势.
探索这些评估如何影响药物开发能力,制造和临床战略.

主要方法:

一个分为两个阶段的调查分发给制药科学家.
调查使用in silico算法和in vitro测试格式的使用情况.
收集有关应用免疫性风险评估结果的数据.

主要成果:

广泛采用高吞吐率的in silico算法和基于人类免疫细胞的测试.
使用蛋白质组学和专门测试,特别是当作用机制影响风险时.
工具还提供了关于化学,制造和控制 (CMC) 风险的见解,有助于过程开发.

结论:

免疫性风险评估是早期药物开发的组成部分,影响发现,CMC和非临床阶段.
这些评估超出了早期发展范围,以指导临床策略和生物分析.
这些发现突出了针对降低药物开发风险的综合战略的趋势.

关键词:

这是一种生物治疗药物.统一化和化统一化和化免疫性风险免疫性风险在体外测定试验.在临床前的发展.参考材料是参考材料的参考材料.

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