Kurinomaru Takaaki, Maruyama Takuya, Izaki Shunsuke, Handa Kenji, Kimoto Tomoaki, Shiraki Kentaro
Faculty of Pure and Applied Sciences, University of Tsukuba, Tsukuba, Ibaraki, 305-8573, Japan.
J Pharm Sci. 2014 Aug;103(8):2248-54. doi: 10.1002/jps.24025. Epub 2014 Jun 13.
A method for concentration of protein solutions is required for high-dosage protein formulation. Here, we present a precipitation-redissolution method by poly(amino acid) for proteins, including therapeutic enzymes, antibodies, and hormones. The proteins were fully precipitated by the addition of poly-L-lysine or poly-L-glutamic acid at low ionic strength, after which precipitate was dissolved at physiological ionic strength. The activities and secondary structures of redissolved proteins, especially antibodies, were almost identical to the native state. The precipitation-redissolution method is a simple and rapid technique for concentration of protein formulations.
高剂量蛋白质制剂需要一种蛋白质溶液浓缩方法。在此，我们提出一种通过聚氨基酸对蛋白质进行沉淀 - 再溶解的方法，该方法适用于包括治疗性酶、抗体和激素在内的各种蛋白质。在低离子强度下加入聚 - L - 赖氨酸或聚 - L - 谷氨酸可使蛋白质完全沉淀，然后在生理离子强度下将沉淀溶解。再溶解后的蛋白质，尤其是抗体的活性和二级结构几乎与天然状态相同。沉淀 - 再溶解方法是一种用于蛋白质制剂浓缩的简单快速技术。
