Quality of bevacizumab (Avastin®) repacked in single-use glass vials for
            intravitreal administration

Sugimoto, Michelle A.; Toledo, Vicente de Paulo Coelho Peixoto de; Cunha, Mariem Rodrigues Ribeiro; Carregal, Virgínia Mendes; Jorge, Rodrigo; Leão, Pedro Puech; Fialho, Sílvia Ligório; Silva-Cunha, Armando

doi:10.5935/0004-2749.20170026

Cited by 2 publications

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“…Due to the clinical applicability of these drugs and high cost, the use of lower cost compounded single-use vials is important. Compounding is the subdivision of the packaging of a drug into individual parts to facilitate the availability of the amount established by the medical prescription [ 32 ] to reduce the treatment cost.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of aflibercept and ziv-aflibercept binding affinity to vascular endothelial growth factor, stability and sterility after compounding

et al. 2018

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PurposeTo investigate the binding affinity, stability, and sterility of aflibercept and ziv-aflibercept to vascular endothelial growth factor (Holash et al. in Proc Natl Acad Sci USA 99(17):11393–11398, 2002. 10.1073/pnas.172398299) after compounding and storage for up to 28 days at 4 °C and − 8 °C.MethodsTuberculin-type 1-mL syringes were prepared containing aflibercept (40 mg/mL) and ziv-aflibercept (25 mg/mL). Samples were stored at 4 °C and − 8 °C for 0, 14, and 28 days and evaluated for the binding affinity of anti-VEGF to VEGF and stability using enzyme-linked immunosorbent assays. The evaluation of sample sterility was performed.ResultsLaboratory trials with aflibercept and ziv-aflibercept showed preservation of the drug-binding capability to recombinant VEGF when stored in plastic syringes for up to 28 days at 4 °C and − 8 °C. No significant decrease in mass or concentration were observed. Microbiologic evaluations did not detect contamination in the syringes.ConclusionsThe current study corroborates that compounded anti-VEGF drugs aflibercept and ziv-aflibercept do not loose stability or binding affinity and do not become contaminated if prepared under sterile conditions and stored at 4 °C or − 8 °C for 14 or 28 days.

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Section: Introductionmentioning

confidence: 99%

Evaluation of aflibercept and ziv-aflibercept binding affinity to vascular endothelial growth factor, stability and sterility after compounding

et al. 2018

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Long-Term Physical Stability, Sterility, and Anti-Vegf Bioactivity of Repackaged Bevacizumab in 2-Ml Glass Vials

Peterson

Rockwell

et al. 2019

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Quality of bevacizumab (Avastin®) repacked in single-use glass vials for intravitreal administration

Abstract: The results showed that bevacizumab remained stable after compounding in ampoules and single-use glass vials; no significant aggregation, fragmentation, or loss of biological activity was observed.

Cited by 2 publications

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Evaluation of aflibercept and ziv-aflibercept binding affinity to vascular endothelial growth factor, stability and sterility after compounding

Evaluation of aflibercept and ziv-aflibercept binding affinity to vascular endothelial growth factor, stability and sterility after compounding

Long-Term Physical Stability, Sterility, and Anti-Vegf Bioactivity of Repackaged Bevacizumab in 2-Ml Glass Vials

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