Abstract
In this work, the stability of Bevacizumab (Avastin®) repackaged in individual 1 mL single-use syringes and stored at different conditions was assessed. Bevacizumab repackaged in single-use syringes results from the off-label use of the drug as an intravitreal agent in the treatment of retinal diseases. Bevacizumab stability was assessed by assaying the anti-VEGF activity using an indirect ELISA method and a Dynamic Light Scattering study. The thermal stability of the drug was also studied by calorimetric analysis, aimed to evaluate thermodynamic parameters associated to the thermal unfolding process. Furthermore, microbiological and fungal tests on the Bevacizumab syringes were performed. As a result, a significant decrease of the anti-VEGF activity was detected when syringes were exposed to UV light at a temperature of 37°C. Under these conditions, the Dynamic Light Scattering study showed an increase of the average size of Bevacizumab; probably due to aggregation. In conclusion, Bevacizumab stability, when stored under different conditions, was assessed considering three different aspects: anti-VEGF activity, microbial contamination and physico-chemical properties. Bevacizumab was found to be stable, under sterile conditions, for 3 months at 4°C and for 7 days at room temperature, exposed to indirect light sources, while a brief exposure of the drug to direct UV radiation proved detrimental to drug stability.
Keywords: Anti-VEGF activity, Bevacizumab, Bevacizumab stability, calorimetric studies, dynamic light scattering, repackaged Bevacizumab, microbiological assay, immunoassay.
Current Pharmaceutical Biotechnology
Title:Quantification, Microbial Contamination, Physico-chemical Stability of Repackaged Bevacizumab Stored Under Different Conditions
Volume: 15 Issue: 2
Author(s): Leonarda Signorello, Stefania Pucciarelli, Giulia Bonacucina, Valeria Polzonetti, Marco Cespi, Diego R. Perinelli, Giovanni F. Palmieri, Riccardo Pettinari, Claudio Pettinari, Giovanni Fiorentini and Silvia Vincenzetti
Affiliation:
Keywords: Anti-VEGF activity, Bevacizumab, Bevacizumab stability, calorimetric studies, dynamic light scattering, repackaged Bevacizumab, microbiological assay, immunoassay.
Abstract: In this work, the stability of Bevacizumab (Avastin®) repackaged in individual 1 mL single-use syringes and stored at different conditions was assessed. Bevacizumab repackaged in single-use syringes results from the off-label use of the drug as an intravitreal agent in the treatment of retinal diseases. Bevacizumab stability was assessed by assaying the anti-VEGF activity using an indirect ELISA method and a Dynamic Light Scattering study. The thermal stability of the drug was also studied by calorimetric analysis, aimed to evaluate thermodynamic parameters associated to the thermal unfolding process. Furthermore, microbiological and fungal tests on the Bevacizumab syringes were performed. As a result, a significant decrease of the anti-VEGF activity was detected when syringes were exposed to UV light at a temperature of 37°C. Under these conditions, the Dynamic Light Scattering study showed an increase of the average size of Bevacizumab; probably due to aggregation. In conclusion, Bevacizumab stability, when stored under different conditions, was assessed considering three different aspects: anti-VEGF activity, microbial contamination and physico-chemical properties. Bevacizumab was found to be stable, under sterile conditions, for 3 months at 4°C and for 7 days at room temperature, exposed to indirect light sources, while a brief exposure of the drug to direct UV radiation proved detrimental to drug stability.
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Signorello Leonarda, Pucciarelli Stefania, Bonacucina Giulia, Polzonetti Valeria, Cespi Marco, Perinelli R. Diego, Palmieri F. Giovanni, Pettinari Riccardo, Pettinari Claudio, Fiorentini Giovanni and Vincenzetti Silvia, Quantification, Microbial Contamination, Physico-chemical Stability of Repackaged Bevacizumab Stored Under Different Conditions, Current Pharmaceutical Biotechnology 2014; 15 (2) . https://dx.doi.org/10.2174/1389201015666140619120834
DOI https://dx.doi.org/10.2174/1389201015666140619120834 |
Print ISSN 1389-2010 |
Publisher Name Bentham Science Publisher |
Online ISSN 1873-4316 |
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