Stability study over time of clinical solutions of ziv-aflibercept prepared in infusion bags using a proper combination of physicochemical and functional strategies

Journal of Pharmaceutical and Biomedical Analysis(2021)

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摘要
•Ziv-AFL clinical solutions long-term stability evaluated by validated analytical strategies.•The 4 and 0.6 mg/mL Ziv-AFL in 0.9 % NaCl stored in polyolefin infusion bags showed great stability over two weeks.•Ziv-AFL no degradation products and no aggregation were demonstrated.•Ziv-AFL ability to specifically binds to VEGF was proved by ELISA.
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关键词
Ziv-Aflibercept,Fc-fusion protein,Infusion bags,Stability study
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