Revolutionary bevacizumab (Avastin®) injection from a 503B outsourcing facility.
The innovative new bevacizumab (Avastin®) filled Daikyo Crystal Zenith® syringe, available from Fagron Sterile Services US (FSS), is produced with state-of-the-art Groninger automation through cGMP compliant operations to deliver a groundbreaking advancement.
You care about your patients; they trust your judgment.
bevacizumab (Avastin®), produced with industry leading Groninger automation
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.”
Director, Commercial Technology Development
West Pharmaceutical Services, Inc.
The bevacizumab (Avastin®) filled Daikyo Crystal Zenith® syringe, a collaboration between Fagron Sterile Services US (FSS) and West Pharmaceutical Services, Inc. is designed for the long-term storage and administration of a biologic. This unique collaboration will change the paradigm for sterile compounded ophthalmic injections.
This distinctive sterile ophthalmic product fulfills a highly anticipated need by creating a specifically configured clean container and automated filling process for repackaged bevacizumab (Avastin®) syringes.
All the syringes on the market are deeply flawed, creating a danger to patient safety, by depositing silicone oil droplets in the patients’ eyes. Interaction between the plastic transfer syringes, rubber stoppers and surface lubricants used on the barrel of the syringes may be tied to an increased risk of inflammatory endophthalmitis, high intraocular pressure, floaters, blurred vision and risk of ocular hemorrhage1.
The syringes commonly used for these injections were never designed for long term storage of drug products particularly not one with the sensitivity of a large molecule biologic and are expressly prohibited for use in intravitreal injections by their manufacturer2.
Innovation from process to product
This revolutionary new product sets a new standard for high-quality sterile ophthalmic compouding. The collaboration between FSS and West provides a pharmaceutically elegant, specially created biologics container, filled by an automated process; eliminating the reliance on human contact and manual syringe manipulation to prepare a sterile product.
FDA / DEA Registered & Inspected
cGMP Compliant
ISO 5 environments
Committed Supply
100% Tested
Industry Leading Automation
Groninger Filling Machines are recognized as a global leader in syringe processing with nested pre-sterilized syringes preventing possibilities of microbiological contamination.
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.
Daikyo Crystal Zenith® Cyclic Olefin Polymer Syringe Features:
Syringe Dimension Specification
Avastin® Dosing Accuracy
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.
Did you know?
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.
The use of off-label Avastin® (bevacizumab) provides billions of dollars of cost savings to insurers, patients and taxpayers and is the genesis of all innovation in this field7.
About Fagron Sterile Services US
FSS, a top-tier DEA and FDA-registered 503B Outsourcing Provider, produces reliable supply of high-quality sterile medications with cGMP compliant operations, for patient-focused healthcare facilities across North America.
FSS’ team employs expertise in legal and regulatory compliance, pharmaceutical manufacturing, and repackaging, leveraging industry leading automation, advanced environmental monitoring, and sophisticated in-house quality testing labs.
1. Reference
2. BD Letter to Customers product information June 14, 2018
3. Avastin | Weill Cornell Medicine
4. Genentech in Competition With Itself on Eye Drug
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
6. Medicare Part B Drug Spending Dashboard
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.
