Last update :
19/11/2024
References   References 4271  
Type : Journal
Web link : https://www.ncbi.nlm.nih.gov/pubmed/31102205

Research teams : Incheon - Quality Evaluation Team, Samsung Bioepis Co
Authors : Yun J, Kim J, Chung J, Hwang S-J, Park S-J.
Title : Extended Stability of Reconstituted and Diluted SB3 (Trastuzumab Biosimilar) Assessed by Physicochemical and Biological Properties
Reference : Adv Ther 2019

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

List of drugs
injectionTrastuzumab Anticancer drug
Stability in solutions Glass Water for Injection 21 mg/ml 23-27°C Protect from light
3 Day
Biosimilar
Stability in solutions Polyethylene Sodium chloride 0,9% 0,32 mg/ml 2-8°C Protect from light
28 Day
Biosimilar
Stability in solutions Polyethylene Sodium chloride 0,9% 0,32 mg/ml 23-27°C Protect from light
28 Day
Biosimilar
Stability in solutions Polyethylene Sodium chloride 0,9% 0,56 mg/ml 2-8°C Protect from light
28 Day
Biosimilar
Stability in solutions Polyethylene Sodium chloride 0,9% 0,56 mg/ml 23-27°C Protect from light
28 Day
Biosimilar
Stability in solutions Polyethylene Sodium chloride 0,9% 4 mg/ml 2-8°C Protect from light
28 Day
Biosimilar
Stability in solutions Polyethylene Sodium chloride 0,9% 4 mg/ml 23-27°C Protect from light
28 Day
Biosimilar

  Mentions Légales