Extended stability of the trastuzumab biosimilar ABP 980 (KANJINTI®) in polyolefin bags and elastomeric devices
Category: Original Research
96 total, 3 today
Keywords: biosimilar, elastomeric device, KANJINTI® ABP 980, stability, trastuzumab
Author byline as per print journal:
Lyndsay Davies1, PhD; Katie Milligan1, BSc; Mark Corris1, BSc; Ian Clarke1; Paul Dwyer1, MSc; Sarah Elizabeth Lee2, PhD; Jolene Teraoka3, BSc; Jill Crouse-Zeineddini3, PhD; Jane Hippenmeyer4, PharmD
Study Objectives: To investigate the quality and in-use stability of the trastuzumab biosimilar, ABP 980 (KANJINTI®) product in both concentrated multi-dose bags and following dilution and extended storage in intravenous bags and elastomeric devices, to address the stability requirements of different global pharmacy practices.
Methods: The effect of extended refrigerated storage plus exposure to in-use temperature conditions on ABP 980 solutions was assessed using a range of stability-indicating analytical methods, including appearance, pH, SEC, non-reducing CGE, reducing-CGE, CZE, sub-visible particle counting and potency by a cell-based proliferation inhibition assay. Stability of reconstituted 21 mg/mL solution stored in multi-dose bags and diluted samples at 0.3, 0.8 and 4 mg/mL in 0.9% w/v NaCl solutions stored in intravenous bags and elastomeric devices was determined. Forced degraded samples exposed to room temperature and natural daylight were used to demonstrate the stability-indicating abilities of the methods.
Results: No significant changes were observed in the appearance, pH, monomer concentration, purity, charge heterogeneity, sub-visible particle counts or bioactivity, regardless of initial concentration, container or storage duration.
Discussion: There was no indication of significant changes to the physicochemical stability or bioactivity of any of the solutions following extended storage when compared to the initial results acquired on the day of preparation.
Conclusion: The data presented has demonstrated the physicochemical stability and bioactivity of a range of trastuzumab (ABP 980) solutions when prepared using controlled and validated aseptic processes, stored protected from light for extended periods at 2°C–8°C and subjected to in-use temperatures. The stability demonstrated in multi-dose bags and elastomeric devices provides additional preparation options to address different global pharmacy practices and requirements.
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