Department of Pharmacy, Pharmaceutical Technology & Biopharmaceutics, Ludwig-Maximillians-University Munich, Butenandtstr. 5-8, 81377 Munich, Germany.
Innovation Centre Complex Formulations, Fresenius Kabi Deutschland GmbH, Pfingstweide 53, 61169 Friedberg, Germany.
Int J Pharm. 2015 Nov 10;495(1):608-611. doi: 10.1016/j.ijpharm.2015.09.031. Epub 2015 Sep 24.
A comparison of lyophilized PEGylated and HESylated IFNα was carried out to investigate the influence of protein conjugation, lyoprotectants as well as storage temperature on protein stability. Results show that PEG tends to crystallize during freeze-drying, reducing protein stability upon storage. In contrast, HESylation(®) drastically improved the stability over PEGylation by remaining totally amorphous during lyophilization, with and without lyoprotectants while providing a high glass transition temperature of the freeze-dried cakes.
进行了冻干的聚乙二醇化和 HES 化 IFNα 的比较，以研究蛋白质结合、冷冻保护剂以及储存温度对蛋白质稳定性的影响。结果表明，PEG 在冷冻干燥过程中倾向于结晶，从而降低了储存时的蛋白质稳定性。相比之下，HES 化（®）通过在有和没有冷冻保护剂的情况下在冷冻干燥过程中保持完全无定形，极大地提高了 PEG 化的稳定性，同时提供了冷冻干燥蛋糕的高玻璃化转变温度。
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