用加速稳定性评估程序建模预测口服输送抗体药物产品的长期稳定性
Lulu Dai1, Jeff Davis1, Karthik Nagapudi1
1Synthetic Molecule Pharmaceutical Science, Early Research and Development, Genentech, South San Francisco, California 94080, United States.
这项研究评估了口服蛋白质疗法的稳定性,特别是重链抗体 (VHH抗体) 药物产品的可变域. ASAPprime软件准确预测了蛋白质的稳定性,突出了口服生物药物开发的新方法.
科学领域:
- 制药科学 制药科学
- 生物技术是生物技术.
- 药物运输 药物运输 药物运输
背景情况:
- 口服蛋白疗法提供了患者的好处,但面临着发展挑战.
- 关于口服蛋白质药物的稳定性和保质期的数据有限.
- 评估固态蛋白质配方的稳定性对于药物开发至关重要.
研究的目的:
- 综合评估口服固体剂量的VHH抗体药物产品的稳定性.
- 应用和验证一种加速稳定性方法来预测蛋白质药物稳定性.
- 解决有关口服蛋白质治疗药物的保质期的知识差距.
主要方法:
- 确定了对热和湿度压力敏感的四个关键质量属性.
- 采用ASAPprime软件来加速VHH抗体药物产品的稳定性建模.
- 与观察到的稳定性数据对比验证的模型预测.
主要成果:
- 在储存期间实现了良好的模型质量和准确的蛋白质稳定性预测.
- 观察到蛋白质聚合需要对建模方法进行特定的调整.
- 证明了ASAP方法对复杂的固态蛋白质配方的有希望的实用性.
结论:
- ASAP方法显示了预测口服VHH抗体药物产品的稳定性的潜力.
- 这项研究为口服蛋白质治疗药物的稳定性和保质期提供了宝贵的见解.
- 这些发现有助于推进口服生物药物配方的开发.
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