差示扫描量热法
结晶
化学
蛋白质聚集
低温保护剂
粒子聚集
生物物理学
色谱法
化学工程
粒径
粒子(生态学)
材料科学
纳米技术
低温保存
生物化学
热力学
有机化学
物理
地质学
工程类
海洋学
物理化学
纳米颗粒
细胞生物学
胚胎
生物
作者
Astrid Hauptmann,Katja Podgoršek,Drago Kuzman,Stane Srčič,Georg Hoelzl,Thomas Loerting
标识
DOI:10.1007/s11095-018-2378-5
摘要
This study addresses the effect of freezing and thawing on a therapeutic monoclonal antibody (mAb) solution and the corresponding buffer formulation. Particle formation, crystallization behaviour, morphology changes and cryo-concentration effects were studied after varying the freezing and thawing rates, buffer formulation and protein concentration. The impact of undergoing multiple freeze/thaw (FT)-cycles at controlled and uncontrolled temperature rates on mAb solutions was investigated in terms of particle formation.Physicochemical characteristics were analysed by Differential Scanning Calorimetry whereas morphology changes are visualized by cryomicroscopy measurements. Micro Flow Imaging, Archimedes and Dynamic Light Scattering were used to investigate particle formation.Data retrieved in the present study emphasizes the damage caused by multiple FT-cyles and the need for sucrose as a cryoprotectant preventing cold-crystallization specifically at high protein concentrations. Low protein concentrations cause an increase of micron particle formation. Low freezing rates lead to a decreased particle number with increased particle diameter.The overall goal of this research is to gain a better understanding of the freezing and thawing behaviour of mAb solutions with the ultimate aim to optimize this process step by reducing the unwanted particle formation, which also includes protein aggregates.
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