抗体与药物合物的基本性质和重点领域 配方开发开发
Lili Wen1, Yuanyuan Zhang1, Chenxi Sun1
1Department of Bioconjugate Product Development and Manufacturing, WuXi XDC Co., Ltd., Wuxi, Jiangsu, P.R. China.
抗体-药物联合体 (ADC) 是先进的治疗药物,但它们的稳定性需要冷解制剂. 本综述全面分析了ADC配方策略,挑战和液体配方的未来方向.
科学领域:
- 生物制药配方 生物制药配方
- 药物输送系统是药物输送系统.
- 结合化学 结合化学
背景情况:
- 抗体-药物联合体 (ADC) 是一个不断增长的治疗类,以其特异性和有效性而闻名.
- 由于与未结合抗体相比,与固有的稳定性挑战相比,大多数批准的ADC使用冷化配方.
研究的目的:
- 提供商业ADC中配方策略的全面分析.
- 识别和解决ADCs,特别是液体配方的独特配方开发挑战.
- 为未来的ADC配方进步提供战略视角.
主要方法:
- 对商业ADC配方的综合文献综述.
- 从早期阶段到制造业的配方开发工作流程的分析.
- 对ADC与非结合抗体配方挑战的比较分析.
主要成果:
- 在16种批准的ADC中,有14种是冷化的,这凸显了稳定性问题.
- 详细检查ADC开发生命周期中的制定策略.
- 确定ADC液体配方开发中的特定技术障碍.
结论:
- ADC的配方对于治疗成功至关重要,具有独特的挑战,需要专门的策略.
- 解决稳定性和复杂性是推进液体ADC配方的关键.
- 未来的研究应该专注于创新的方法来克服目前ADC配方的局限性.
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