title: Quantification, microbial contamination, physico-chemical stability of repackaged bevacizumab stored under different conditions.
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.
authors: Leonarda
authors: L
authors: Signorello
authors: Stefania
authors: S
authors: Pucciarelli
authors: Giulia
authors: G
authors: Bonacucina
authors: Valeria
authors: V
authors: Polzonetti
authors: Marco
authors: M
authors: Cespi
authors: Diego R
authors: DR
authors: Perinelli
authors: Giovanni F
authors: GF
authors: Palmieri
authors: Riccardo
authors: R
authors: Pettinari
authors: Claudio
authors: C
authors: Pettinari
authors: Giovanni
authors: G
authors: Fiorentini
authors: School of School of Biosciences and Veterinary Medicine, University of Camerino, Via circonvallazione 93/95, 62024 Matelica (MC), Italy. silvia.vincenzetti@unicam.it.
authors: Silvia
authors: S
authors: Vincenzetti
mesh_terms: D020533:Angiogenesis Inhibitors / Q000032:analysis* / Q000737:chemistry; D061067:Antibodies, Monoclonal, Humanized / Q000032:analysis* / Q000737:chemistry; D000068258:Bevacizumab; D004340:Drug Contamination; D004349:Drug Packaging; D004355:Drug Stability; D004356:Drug Storage; D013696:Temperature
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab