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Key Quality Attributes of Parenteral Grade Excipients

Quantitative Characterization of Sucrose, Trehalose, and Mannitol The complexity of large molecule and cell-based therapeutics continues to increase. This trend, coupled with an evolving regulatory landscape across the globe, has driven requirements for enhanced characterization of critical formulation components, especially for injectables. As a US-based cGMP manufacturer of critical stabilization technologies such as trehalose, sucrose, maltose, and mannitol, Pfanstiehl has performed quantitative characterization for several key quality attributes, down to levels well beyond those required by the pharmacopeia. The intent is to share quantitative (rather than qualitative) data with formulators, not only for peace of mind in terms of long term regulatory compliance, but to remove unknowns from experimental design and enable scientists to build more robust formulation platforms. Quantitative data for multi-compendial release testing, total and elemental impurities (down to low ppb levels), endotoxins, glucans, and sub-visible particles are disclosed herein.

 


分析在注射级蛋白质稳定剂中的金属含量
Jason Forbes、Larry Lonski 和 Chris Wilcox

在药物制剂配方中,蔗糖、海藻糖、甘露醇、麦芽糖是用于蛋白质稳定化的 4 个最常用糖类。 随着注射辅料的需求不断攀升,生物制药产业开始考虑要求具有更多关于种类繁多的微小成分(包括金属)更大范围分析方面的指导。 尽管许多这些辅料纯度都很高,但对于制造商来说了解非糖部分表达谱以及它们在原材料和处理过程中如何变化也很重要。 在此,我们呈现了关于经验证后 Pfanstiehl 可注射级平台辅料的分析结果。 具体而言,对于每个批次的海藻糖、蔗糖、甘露醇和麦芽糖都要测试钒、铬、锰、铁、镍、铜、锌、丙烯腈、钼、铑、钯、镉、锇、铱、铂、汞和铅的水平。 讨论观察数据所得结论并拟定下一步骤。

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