Last update :
26/03/2025
References   References 4891  
Type : Journal
Web link : https://doi.org/10.1007/s40123-022-00645-1

Research teams : Incheon - Quality Evaluation Team, Samsung Bioepis Co
Authors : Kaiser P.K, Yun J, Kim S, Kim J, Park S.J.
Title : Physicochemical and Biological Stability Assessment of SB11 (Ranibizumab Biosimilar) Under Ambient and In-Use Storage for Intravitreal Administration.
Reference : Ophtalmol Ther ; 12:985–998. 2023

Level of Evidence : 
Level of evidence C
Physical stability : 
Turbidimetry Protein: Size Exclusion Chromatography Protein: Dynamic Light Scattering Visual examination 
Chemical stability : 
Capillary electrophoresis
Other methods : 
PH measurement 
Comments : 
Proteins: biological activity by cell culture
Proteins: biological activity by enzymatic technique

List of drugs
injectionRanibizumab Various
Stability in solutions Glass None 10 mg/ml 28-32°C Protect from light
60 Day
Biosimilar
Stability in solutions Polypropylen Syringe None 10 mg/ml 2-8°C Protect from light
98 Day
Biosimilar
Stability in solutions Polypropylen Syringe None 10 mg/ml 23-27°C Protect from light
24 Hour
Biosimilar
Stability in solutions syringe polycarbonate None 10 mg/ml 2-8°C Protect from light
98 Day
Biosimilar
Stability in solutions syringe polycarbonate None 10 mg/ml 23-27°C Protect from light
24 Hour
Biosimilar

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