泊洛沙姆188复验后再使用研究

Study on retest period of poloxamer 188

目的:研究泊洛沙姆188复验期后放置时间对其品质和细胞培养的影响,为泊洛沙姆188复验期的确定提供依据。方法:分别对复验期后6个月、24个月和36个月的泊洛沙姆188进行pH、内毒素含量测定、拉曼鉴别和细胞培养测试,评估其作为培养基组分对细胞生长和重组蛋白表达的影响。结果:泊洛沙姆188在复验期后36个月以内的pH、内毒素含量和拉曼鉴别符合标准,使用复验期后24个月以内的泊洛沙姆188对细胞生长、活率和表达量与复验期内的无显著差异,但使用复验期后36个月的泊洛沙姆188细胞生长和活率及重组蛋白表达量均降低。结论:泊洛沙姆188用于无血清培养基组分时,复验期建议为24个月。

Objective:To study the effect of Poloxamer 188 after the retest period on its quality and cell culture.Methods:The determination of pH,endotoxin content and cell culture and the identification of Raman spectra to poloxamer 188 at 6,24 and 36 months after the retest period were performed to evaluate its effects on cell growth and recombinant protein expression as a medium component.Results:The pH,endotoxin content and Raman identification of poloxamer 188 within 36 months after the retest period met the related standards.Poloxamer 188 within 24 months after retest date showed no differences in cell growth and viability and the protein expression compared with one within retest date,however,those indicators were all decreased when poloxamer 188 stored for 36 months after retest date was used.Conclusion:The retest period of poloxamer 188 is suggested to be 24 months after retest date as a component for serum free medium.