Revolutionary bevacizumab (Avastin®) injection from a 503B outsourcing facility.
The syringes being used in the industry today are flawed in every way with detrimental effects for practitioners, negative impact on clinical outcomes, and vision threatening serious adverse events potentially endangering patient safety.
Susan M. Dounce, Ph.D., Director of Commercial Technology Development for West Pharmaceutical Services, Inc. states,
“Ophthalmic injections represent one of the highest risk categories in all of injectable drug delivery. These are often repeat injections into the confined space of the eye, ultimately with the patient’s vision at stake. Historically, not enough has been done to manage these risks, especially as they relate to the syringe used to store or deliver the drug. We now have an option to reduce the risks that inadequate syringe systems can introduce.”
Groninger uses a Flexicon high-accuracy peristaltic pump providing 3% filling accuracy. The filling machine is installed inside a Restricted Access Barrier System (RABS) providing an Aseptic Processing environment reducing or eliminating interventions (human intervention) into critical zones of the filling process.
The processing suite is equipped with its own air handling unit (AHU), independent high-quality filtration and continuous environmental monitoring.The RABS system provides unidirectional airflow providing a Class A (ISO-5) environment pushing air though terminal Ultra-Low Particulate Air (ULPA) filters removing 99.9995% of particles down to 0.1 (µm) micrometers.
The Groninger filling machine and RABS system are fully validated per FDA 21 Code of Federal Regulations (CFR).
The CFR is a codification of the general and permanent rules published in the Federal register by the Executive departments and agencies of the Federal Government. Title 21 of the CFR is reserved for rules of the Food and Drug Administration (FDA).
The equipment uses all presterilized components which are loaded, filled, and finished in the ISO-5 environment.
Presterilized trays are loaded in the fill machine, a finite amount of sterilized fluid is dispensed into each syringe via peristaltic pumps and two needles.
The syringes are then stoppered and removed from the machine for post-production quality inspections.
Administration subjectivity can result in large variations of a drug administered to the patient. Studies have demonstrated that dosing errors can be as high as 50% with either over or under dosing depending on the syringe3.
Dosing accuracy, or the amount of drug administered to the patient, is of critical importance to support patient safety and successful clinical outcomes. Without an accurate, constant volume of medicine, the quality of treatment may vary. This is particularly important in Avastin® injections where the volume of drug administered is so small.
The new presentation from FSS addresses these concerns and brings to market the first highly accurate, ergonomic container, intended for Avastin® administration.
Age related macular degeneration (AMD) is known to be the leading cause of vision loss among older Americans. Avastin® was the first anti-VEGF drug used to treat this and multiple other eye diseases4.
Avastin® saves Medicare and other insurers billions of dollars each year5. It is commonly used off label for the treatment of wet age-related macular degeneration (AMD) and multiple other ophthalmic indications.
The FDA-approved drugs for intravitreal treatment are consistently in the top 10 highest spend drugs for Medicare Part B since 2013, reaching a total of $3.5 billion in 20176.
2. BD Letter to Customers product information June 14, 2018
5. Rosenfeld PJ, Windsor MA, Feuer WJ, Sun SJJ, Frick KD, Swanson EA, Huang D. Estimating Medicare and Patient Savings from the Use of Bevacizumab for the Treatment of Exudative Age-related Macular Degeneration. American Journal of Ophthalmology. July 2018; 191:135-139
7. Estimating Medicare and Patient Savings From the Use of Bevacizumab for the Treatment of Exudative Age-related Macular DegenerationRosenfeld, Philip J. et al. American Journal of Ophthalmology, Volume 191, 135 – 139
Crystal Zenith® and Daikyo Flurotec® are registered trademarks of Daikyo Seiko, Ltd. Avastin® is a registered trademark of Genentech, Inc.