实验设计在ADC药物处方筛选中的应用  

Application of design of experiment in the formulation screening of antibody drug conjugate

作　　者：杜翊 章燕珍 谭小钉[1] 

机构地区：[1]上海医药集团股份有限公司中央研究院,上海200237

出　　处：《上海医药》2018年第1期71-75,共5页Shanghai Medical & Pharmaceutical Journal

摘　　要：目的:运用实验设计(DOE)方法优化抗体偶联药物(ADC)处方筛选,以得到适用于该ADC药物的较优处方。方法:利用JMP 10软件进行DOE,考察蛋白浓度、pH、蔗糖和吐温20浓度等因素对ADC药物稳定性的影响。结果:经过DOE方法的优化,得到了蛋白浓度(10 mg/ml)、pH(5.0)、蔗糖浓度[6%(w/v)]和吐温20浓度[0.02%(w/v)]的优选组合。结论:DOE方法能优化处方,提高ADC药物的稳定性,为其他ADC药物的处方筛选提供了借鉴。Objective： To optimize the formulation screening of antibody drug conjugate （ADC） by a method of design of experiment （DOE） so as to obtain a superior formulation for the ADC drug. Methods： DOE was performed by a software JMP 10 to investigate the efects of the concentrations of protein, sucrose and polysorbate 20 and pH value on the stability of ADC drug. Results： A preferred combination including 10 mg/ml protein, 6% （w/v） sucrose and 0.02% （w/v） polysorbate 20 and pH 5.0 was obtained by optimization of DOE method. Conclusion： DOE can optimize the formulation and improve the stability of ADC drug. This study can also provide a reference for the screening of other ADC drugs.

关 键 词：实验设计 ADC药物 处方筛选 

分 类 号：R927.11[医药卫生—药学] R979.19