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单基脂替代多酸盐作为介面稳定剂在亲肠道单克隆抗体配方中的单基脂

Eleni Papadopoulos¹, Imke Leitner¹, Wolfgang Friess¹

¹Ludwig-Maximilians-Universität München, Department of Pharmacy, Pharmaceutical Technology and Biopharmaceutics, Butenandtstraße 5-13 B 81377 Munich, Germany.

European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences

|July 5, 2025

概括

单酸脂 (MAPLs) 提供优越的蛋白质稳定性和化学耐药性,相比于亲肠配方中的多酸80 . 这些新型表面活性剂显示出增强单克隆抗体 (mAbs) 稳定性的前景.

科学领域:

生物制药配方生物制药配方
蛋白质稳定蛋白质稳定
表面活性剂的化学成分

背景情况:

基于蛋白质的药物在水溶液中面临物理和化学不稳定性.
聚酸盐 (PS),常见的表面活性剂,可以通过水解和氧化降解,导致蛋白质聚合和氧化.
聚酸盐的降解产物可能会导致颗粒的形成,并损害对肠道配方中的蛋白质稳定性.

研究的目的:

研究单基脂 (MAPL) 作为单克隆抗体 (mAb) 配方中聚酸盐80 (PS80) 的潜在替代品.
为了比较MAPLs与PS80在预防蛋白质聚合和评估化学稳定性方面的疗效.
评估MAPLs在血液溶解活性方面的安全概况.

主要方法:

测试了不同脂肪酸链的各种MAPL,以在动和冷解周期期间稳定mAb.
评估了表面活性剂对酶性水解 (猪肝雌激酶) 和强制氧化的稳定性.
在长期储存和冷化后,在液体配方中评估了mAb的稳定性.
将MAPL性能与PS80进行比较,包括界面张力测量和预装注射器中的化保存.

主要成果:

在低于溶血值的度下,MAPLs有效地防止了mAb颗粒的形成.
与PS80.0相比,MAPL对酶性水解和氧化具有更强的抗性.
在长期液体储存中,lysomyristoyl-phosphatidylcholine (LPC 14:0) 提供了比PS80更好的mAb稳定性.
在冷化后,MAPLs表现出与PS80相似或优于mAb的稳定性,并且预填注射器化后保存得更好.

结论:

单酸脂 (MAPLs) 是单克隆抗体配方的有效界面稳定剂.
与聚酸80相比,MAPL具有更好的化学稳定性和耐降解性.
MAPLs代表了亲肠道蛋白质配方的有希望的替代品,需要进一步研究.

关键词:

莱索酸胆是一种酸胆.单基脂类的基脂.聚酸盐的降解降解预装注射器注射器预装注射器蛋白质稳定蛋白质稳定稳定性研究研究.治疗性蛋白质是一种治疗性蛋白质.

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