阴离子交换染色学从10%的静脉注射免疫球蛋白制剂中去除FXIa
Gil Bu Kang1, Alan Huber2, Jihye Lee1
1R&D Center, GC Biopharma Corp., Yongin-si, Republic of Korea.
Frontiers in cardiovascular medicine
|December 11, 2023
概括
静脉注射免疫球蛋白 (IVIG) 的新制造工艺有效地去除激活凝血因子XI (FXIa),防止潜在的血栓栓塞事件. 这确保了患者更安全的IVIG产品.
科学领域:
- 生物化学 生物化学
- 免疫学 免疫学 免疫学
- 过程化学 过程化学
背景情况:
- 一些静脉注射免疫球蛋白 (IVIG) 产品中的残留活性凝血因子XI (FXIa) 与血栓栓塞事件有关.
- 为了确保IVIG治疗的安全性,需要在制造过程中去除FXIa.
研究的目的:
- 设计和评估GC5107的制造工艺,10%的甘氨酸稳定IVIG产品,专门用于FXIa去除.
- 为了确认阴离子交换染色体 (CEX) 步骤在消除FXIa.Ia的有效性和稳定性.
主要方法:
- 使用西斑,ELISA,血栓生成试验,染色体FXIa试验和NaPTT试验来评估前凝性活性.
- 进行了高FXIa度的化研究,以测试CEX染色体的去除能力.
- 对9个连续的GC5107批量进行了分析,以检测残留的FXIa和前凝剂活性.
主要成果:
- 阴离子交换色谱 (CEX) 在加工后将FXIa降低到无法检测的水平.
- 在CEX步骤中,即使在高FXIa负载下,FXI蛋白和活性也被99%以上的去除.
- 所有9个分析的GC5107批量都显示FXIa水平低于检测极限和最小的促凝活性.
结论:
- 一个新的10%IVIG制造工艺,采用CEX染色学,可以有效地去除FXIa.
- 该工艺提供了一种可靠的方法,用于生产更安全的IVIG制剂,降低血栓栓塞的风险.
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