通过液体染色学和质谱学识别生物制剂的综合战略,用于在受监管的环境中进行释放测试
Anna Morales1, Jason Candreva1, Thilina Jayarathne1
1Biologics Development, Bristol Myers Squibb, New Brunswick, NJ, United States.
Journal of pharmaceutical and biomedical analysis
|July 21, 2023
概括
这项研究提出了一个强大的液体染色学-质谱学 (LC-MS) 策略,用于生物制药识别测试. 开发的工作流提供高特异性和快速的结果,用于各种生物制品在良好的生产规范设置.
科学领域:
- 分析化学 分析化学
- 生物制药制造业 生物制药制造业
- 质量控制 质量控制 质量控制
背景情况:
- 监管识别测试对于生物制药制造至关重要.
- 液态染色学-质谱学 (LC-MS) 是一种强大的生物特征分析工具.
- 在质量控制 (QC) 中,LC-MS 由于其复杂性和人员专业知识有限而未得到充分利用.
研究的目的:
- 开发和实施基于LC-MS的生物释放测试的全面识别策略.
- 解决 LC-MS 在 QC 中所感知的复杂性和人员限制.
- 展示LC-MS在传统识别技术上的优势.
主要方法:
- 开发用于LC-MS识别的两个主要工作流 (WF1和WF2).
- WF1:以子单位为基础的测定测量轻链 (LC) 和重链 (HC) 分子重量在减少后.
- WF2:使用PNGase F.使用N-deglycosylation后完整质量测量.
主要成果:
- 该LC-MS策略在40多种不同的生物药物中显示出适用性,包括单克隆抗体 (mAbs),生物改善剂,融合蛋白和大型.
- 实现了极好的质量准确度 (通常<20 ppm) 和精度.
- 建立了单步样本准备和一键数据处理,以促进良好生产规范的实施.
结论:
- 开发的LC-MS策略对于生物释放试验是强大的,具体的和高效的.
- 这些方法对QC友好,并在GMP实验室中成功实施.
- 该策略可适应识别复杂的生物治疗药物,包括固定剂量组合和联合配方产品.
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