The measurement and control of high-risk host cell proteins for polysorbate degradation in biologics formulation.
The measurement and control of high-risk host cell proteins for polysorbate degradation in biologics formulation.
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DOI：
10.1093/abt/tbac002
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发表时间：
2022-01
影响因子：
--
通讯作者：
Roush DJ
中科院分区：
文献类型：
--
作者：
Li X;Wang F;Li H;Richardson DD;Roush DJ
非离子表面活性剂聚山梨酯，包括PS-80和PS-20，通常用于生物治疗产品的配方中，既可以防止表面吸附，又可以作为蛋白质聚集的稳定剂。具有脂肪酶或酯酶活性的微量残留宿主细胞蛋白（HCPs）已被证明可降解生物制剂中的聚山梨酯。测量和控制这些低丰度、高风险的HCPs对聚山梨酸酯的降解是整个行业的挑战，以实现液体制剂中生物制药的预期保质期，特别是对于高浓度制剂产品的开发。在这里，我们回顾了在配方开发过程中聚山梨酯降解的分析方法开发、风险评估和控制策略的挑战、最新进展和未来机遇，重点是酶降解。继续努力提高我们对生物制剂中聚山梨酸酯降解的理解将有助于为患者开发高质量的药物。
Nonionic surfactant polysorbates, including PS-80 and PS-20, are commonly used in the formulation of biotherapeutic products for both preventing surface adsorption and acting as stabilizer against protein aggregation. Trace levels of residual host cell proteins (HCPs) with lipase or esterase enzymatic activity have been shown to degrade polysorbates in biologics formulation. The measurement and control of these low abundance, high-risk HCPs for polysorbate degradation are an industry-wide challenge to achieve desired shelf life of biopharmaceuticals in liquid formulation, especially for high-concentration formulation product development. Here, we reviewed the challenges, recent advances, and future opportunities of analytical method development, risk assessment, and control strategies for polysorbate degradation during formulation development with a focus on enzymatic degradation. Continued efforts to advance our understanding of polysorbate degradation in biologics formulation will help develop high-quality medicines for patients.
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