Abstract
Macular edema due to neovascular age-related macular degeneration, diabetes or retinal vein occlusion can cause central vision loss. Intravitreal treatment with antibody-based biopharmaceutical compounds designed to neutralize vascular endothelial growth factor (VEGF) has proven to be an efficient strategy to ameliorate macular edema and restore visual acuity. At the same time, the use of anti-VEGF drugs places an economic burden on the health care system; the drugs are expensive, and repeated injections are usually required to maintain the therapeutic effect. Thus, there is an unmet need for more cost-effective procedures. We here describe how the most recently approved anti-VEGF drug, aflibercept, can be compounded into prefilled sterile syringes and stored for up to 4 weeks without compromising its quality, stability or functional properties, including VEGF and neonatal Fc receptor (FcRn) binding. The novel compounding method for repackaging of aflibercept in sterile plastic syringes can greatly reduce both cost and time spent per patient in the injection room.
Highlights
Over the last decade, antibody-based biopharmaceutical compounds designed to target vascular endothelial growth factor (VEGF) have revolutionized treatment and prognosis for several retinal diseases, including wet age-related macular degeneration[1,2], diabetic macular edema[3] and macular edema secondary to retinal vein occlusion[4]
It is a recombinant fragment crystallizable (Fc) fusion protein consisting of parts of the extracellular domains of human VEGF receptors 1 and 2 that are genetically fused to the Fc portion of human IgG1
Compounded preparations of bevacizumab are commercially available in many countries; pharmacies split vials into injection-ready syringes that are sold to ophthalmological clinics
Summary
Antibody-based biopharmaceutical compounds designed to target vascular endothelial growth factor (VEGF) have revolutionized treatment and prognosis for several retinal diseases, including wet age-related macular degeneration[1,2], diabetic macular edema[3] and macular edema secondary to retinal vein occlusion[4]. A thorough investigation shows that aflibercept fully maintains its structural stability, VEGF and Fc binding properties after up to 28 days of storage. To investigate whether aflibercept can be compounded and stored in sterile plastic syringes without affecting protein integrity or VEGF and Fc binding properties, commercially obtained aflibercept was drawn into insulin plastic syringes in an isolator unit and transfer chamber following aseptic production procedures.
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