According to a 2017 survey conducted by the American Society of Retina Specialists, ‘Global Trends in Retina’, Avastin is the most commonly used first-line drug for most retinal diseases.1 Avastin must be re-packaged into individual doses for ophthalmic use. In January of 2018, the FDA issued its final guidance on the repackaging of biological products. This guidance, in development for over one year, has required FDA-registered outsourcing facilities to develop new methods for repackaging Avastin, a vital medication for the treatment of retinal diseases.
Leiters takes the Lead in Repackaging Avastin for Retinal Diseases.
In an era of rapid regulatory change and heightened demand for high quality compounded and repackaged drugs, Leiters, an FDA-registered 503B outsourcer, has emerged as a leader. Specializing in ophthalmology and hospital-based services, Leiters provides repackaged Avastin in accordance with the Food and Drug Administration’s 2018 Final Guidance for the Repackaging of Biologics.
At Leiters, all sterile hospital and ophthalmology preparations are produced under Section 503B of the Federal Food, Drug, and Cosmetic Act in our human drug outsourcing facilities, which comply with cGMP.
The Leiters’ Difference Makes a Difference for your Patients.
- FDA compliant
- USP <789> compliant for visible and subvisible particles
- Batch release testing for sterility, endotoxin, color and clarity, visible particles, and subvisible particles
- Repackaged in silicone-free syringe
- Repackaging process that includes an optimized aseptic technique
- cGMP compliance which ensures the biologic product maintains appropriate package integrity during shipping
Leiters is committed to bringing innovative new products to market that meet the highest standards for quality. We’re proud to meet the FDA Guidance for you…and your patients.
In January of 2018, the FDA issued its final guidance on the repackaging of biological products. This guidance, in development for over one year, has required FDA-registered outsourcing facilities to develop new methods for repackaging Avastin, a vital medication for the treatment of retinal diseases. This bulletin describes the background behind the FDA’s action and chronicles one 503B outsourcing facility’s journey to meet the new guidance.
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Avastin ® is a registered trademark of Genentech, Inc.