Last update :
29/10/2024
References   References 4194  
Type : Journal

Research teams : Incheon - R&D Division, Biotechnology Research Institute, Celltrion
Authors : Kim S.J, Lee J.W, Kang H.Y, Kim S.Y, Shin Y.K, Kim K.W, Oh J.S, Lim K.J, Kim J.Y.
Title : In-Use Physichochemical and Biological Stability of the Trastuzumab Biosimilar CT-P6 Upon Preparation for Intravenous Infusion.
Reference : Bio Drugs 32;619-625 2018

Level of Evidence : 
Level of evidence A+
Physical stability : 
Turbidimetry Protein: Size Exclusion Chromatography 
Chemical stability : 
Protein: Peptide mapping
Capillary electrophoresis
Other methods : 
Protein: biological activity 
Comments : 

List of drugs
injectionTrastuzumab Anticancer drug
Stability in solutions Polyvinyl chloride Sodium chloride 0,9% 0,4 mg/ml 2-8°C Not specified
28 Day
Biosimilar
Stability in solutions Polyvinyl chloride Sodium chloride 0,9% 1 mg/ml 2-8°C Not specified
28 Day
Biosimilar
Stability in solutions Polyvinyl chloride Sodium chloride 0,9% 4 mg/ml 2-8°C Not specified
28 Day
Biosimilar
Stability in solutions Polypropylene Sodium chloride 0,9% 0,4 mg/ml 2-8°C Not specified
28 Day
Biosimilar
Stability in solutions Polypropylene Sodium chloride 0,9% 1 mg/ml 2-8°C Not specified
28 Day
Biosimilar
Stability in solutions Polypropylene Sodium chloride 0,9% 4 mg/ml 2-8°C Not specified
28 Day
Biosimilar

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