Storage stability of bevacizumab in polycarbonate and polypropylene syringes

Article


Khalili, H., Sharma, Garima, Froome, Andrew, Khaw, Peng Tee and Brocchini, Steve 2015. Storage stability of bevacizumab in polycarbonate and polypropylene syringes. Eye. 29 (6), pp. 820-827.
AuthorsKhalili, H., Sharma, Garima, Froome, Andrew, Khaw, Peng Tee and Brocchini, Steve
Abstract

Purpose To compare and examine the storage stability of compounded bevacizumab in polycarbonate (PC) and polypropylene (PP) syringes over a 6-month period. PC syringes have been used in a recent clinical study and bevacizumab stability has not been reported for this type of syringe.
Methods Repackaged bevacizumab was obtained from Moorfields Pharmaceuticals in polycarbonate (PC) and polypropylene (PP) syringes. Bevacizumab from the stored syringes was analysed at monthly time points for a 6-month period and compared with bevacizumab from a freshly opened vial at each time point. SDS-PAGE electrophoresis and size-exclusion chromatography (SEC) was used to observe aggregation and degradation. Dynamic light scattering (DLS) provided information about the hydrodynamic size and particle size distribution of bevacizumab in solution. VEGF binding and the active concentration of bevacizumab was determined by surface plasmon resonance (SPR) using Biacore.
Results SDS-PAGE and SEC analysis did not show any changes in the presence of higher molecular species (HMWS) or degradation products in PC and PP syringes from T0 to T6 compared to bevacizumab sampled from a freshly opened vial. The hydrodynamic diameter of bevacizumab in the PC syringe after six months of storage was not significantly different to bevacizumab taken from a freshly opened vial. Using SPR, the VEGF binding activity of bevacizumab in the PC syringe was comparable with bevacizumab taken from a freshly opened vial.
Conclusion No significant difference over a 6-month period was observed in the quality of bevacizumab repackaged into prefilled PC polycarbonate and PP polypropylene syringes when compared to bevacizumab that is supplied from the vial.

Keywordsbevacizumab; compounded bevacizumab; storage stability
JournalEye
Journal citation29 (6), pp. 820-827
ISSN0950-222X
1476-5454
Year2015
PublisherNature Publishing Group
Accepted author manuscript
License
CC BY
Web address (URL)http://dx.doi.org/10.1038/eye.2015.28
Publication dates
Print27 Mar 2015
Publication process dates
Deposited13 Oct 2016
Accepted27 Jan 2015
FunderNational Institute for Health Research
Moorfields Special Trustees
The Helen Hamlyn Trust
Fight For Sight
Freemasons Grand Charity
Michael and Ilsa Katz Charity
Engineering & Physical Sciences Research Council Centre for Innovative Manufacturing in Emergent Macromolecular Therapies
Copyright information© 2015 The authors
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