中国药业2025，Vol.34Issue(21)：57-62,6.DOI:10.3969/j.issn.1006-4931.2025.21.012
抗体偶联药物注射用NCB001模拟临床使用过程的稳定性研究
Simulated Clinical In-Use Stability Study of One Antibody-Drug Conjugate NCB001 for Injection
摘要
Abstract
Objective To evaluate the clinical in-use stability of one antibody-drug conjugate NCB001 for Injection.Methods NCB001 for Injection were reconstituted with sterile water for injection and the required volume were withdrawn and transferred into 250 mL 0.9%Sodium Chloride Injection bag to produce low-dose and high-dose(0.072,1.800 mg/mL)solutions for intravenous infusion.Diluted solutions were stored at-20℃for 24 h,(5±3)℃/protected from light for 6 h or 24 h,or(25±2)℃/5 000 lx light for 6 h,and physicochemical and biological stability were evaluated.Microbial challenge test was used to evaluate the growth of target microorganisms in low-dose and high-dose(0.072,1.800 mg/mL)infusion bags at(5±3)℃and 20-25℃.Results No significant changes in physicochemical properties and biological activity were observed in the low-dose or high-dose solutions of NCB001 for Injection after 24 h of test at(5±3)℃/protect from light,or 6 h at(25±2)℃/5 000 lx light environment.However,numerous white visible particles were observed in both low-dose and high-dose infusion bags after 24 h at-20℃.Microbial challenge test results indicated that no microbial growth was observed within 48 h at(5±3)℃in low-dose or high-dose solutions.While at 20-25℃,increases were observed for Pseudomonas aeruginosa both at 16 h in high-dose solution and at 48 h in low-dose solution,and no increase in growth for the other five challenge microorganisms(Staphylococcus aureus,Escherichia coli,Staphylococcus aureus,Candida albicans,and Aspergillus brasiliensis)within 48 h.Conclusion Diluted NCB001 for Injection should not be frozen and it was suggested to be stored within 24 h at(5±3)℃or within 6 h at room temperature if not used immediately.关键词
抗体偶联药物/注射用NCB001/稀释稳定性/微生物挑战试验Key words
antibody-drug conjugates/NCB001 for Injection/dilution stability/microbial challenge分类
医药卫生引用本文复制引用
梁学军,郭箭,肖礼海..抗体偶联药物注射用NCB001模拟临床使用过程的稳定性研究[J].中国药业,2025,34(21):57-62,6.基金项目
国家科技重大新药创制专项项目[2019ZX09739-001]. （）
