Last update :
16/07/2021
References   References 4525  
Type : Journal
Web link : https://doi.org/10.1007/s12325-020-01465-0

Research teams : Incheon - Quality Evaluation Team, Samsung Bioepis Co
Authors : Park D, Kim J, Yun J, Park S.J.
Title : Evaluation of the Physico-Chemical and Biological Stability of SB8 (Aybintio), a Proposed Biosimilar to Bevacizumab, Under Ambient and In-Use Conditions.
Reference : Adv Ther 2020

Level of Evidence : 
Level of evidence A+
Physical stability : 
Size Exclusion Chromatography Protein: Dynamic Light Scattering Visual examination Particle counting 
Chemical stability : 
Capillary electrophoresis
Other methods : 
Protein: biological activity Measurement of osmolality 
Comments : 

List of drugs
InjectionBevacizumab Anticancer drug
Stability in solutions Glass Sodium chloride 0,9% 25 mg/ml 28-32°C Protect from light
30 Day
Biosimilar
Stability in solutions Polyolefine Sodium chloride 0,9% 1,4 mg/ml 2-8°C Protect from light
45 Day
Biosimilar
Stability in solutions Polyolefine Sodium chloride 0,9% 16,5 mg/ml 28-32°C Protect from light
3 Day
Biosimilar

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