Last update :
18/04/2024
References   References 4754  
Type : Journal
Web link : https://doi.org/10.1177/1078155222107464

Research teams : Andover - Pharmaceutical Research and Development, Pfizer Inc
Authors : Weiser S, Burns C, Zartler E
Title : Physicochemical stability of PF-05280014 (trastuzumab-qyyp; TrazimeraTM), a trastuzumab biosimilar, under extended in-use conditions.
Reference : J Oncol Pharm Practice ;29,3: 2023

Level of Evidence : 
Level of evidence A+
Physical stability : 
Visual examination Turbidimetry Protein: Size Exclusion Chromatography 
Chemical stability : 
Protein: Peptide mapping
Protein: ionic chromatography
Capillary electrophoresis
Other methods : 
PH measurement 
Comments : 
Proteins: biological activity by cell culture

List of drugs
InjectionTrastuzumab Anticancer drug
Stability in solutions Polyvinyl chloride Sodium chloride 0,9% 0,2 & 4 mg/ml 2-8°C Not specified
42 Day
Biosimilar
Stability in solutions Polyolefine Sodium chloride 0,9% 0,2 & 4 mg/ml 2-8°C Not specified
42 Day
Biosimilar
Stability in solutions Ethylene vinyl acetate Sodium chloride 0,9% 0,2 & 4 mg/ml 2-8°C Not specified
42 Day
Biosimilar

  Mentions Légales