Last update :
19/09/2022
References   References 4649  
Type : Journal
Web link : http://gabi-journal.net/extended-stability-of-the-trastuzumab-biosimilar-abp-980-kanjinti-in-polyolefin-bags-and-elastomeric-devices.html

Research teams : Liverpool - Quality Control North West– Liverpool, Pharmacy Practice Unit
Authors : Davies L, Milligan K, Corris M, Clarke I, Dwyer P, Lee S-E, Teraoka J, Crouse-Zeineddini J, Hippenmeyer J.
Title : Extended stability of the trastuzumab biosimilar ABP 980 (KANJINTI™) in polyolefin bags and elastomeric devices.
Reference : GaBI Journal ; 10, 4 2021

Level of Evidence : 
Level of evidence A+
Physical stability : 
Visual examination Particle counting Protein: Size Exclusion Chromatography 
Chemical stability : 
Capillary electrophoresis
Protein: intrared spectrometry and second derivative
Other methods : 
PH measurement Protein: biological activity 
Comments : 

List of drugs
InjectionTrastuzumab Anticancer drug
Stability in solutions Polyolefine Water for Injection 21 mg/ml 2-8°C Protect from light
63 Day
Stability in solutions Polyolefine Sodium chloride 0,9% 0,3 mg/ml 2-8°C Protect from light
21 Day
Stability in solutions Polyolefine Sodium chloride 0,9% 0,8>>4 mg/ml 2-8°C Protect from light
76 Day
Stability in solutions Polyisoprene elastomer Sodium chloride 0,9% 0,3 mg/ml 2-8°C Protect from light
21 Day
Stability in solutions Polyisoprene elastomer Sodium chloride 0,9% 0,8>>4 mg/ml 2-8°C Protect from light
76 Day

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