DENVER, Sept. 19, 2018 /PRNewswire/ -- Leiters, an FDA-registered 503B outsourcing provider of high-quality ophthalmology and hospital-based services, announced today that it is pleased to provide repackaged Avastin in compliance with the Food and Drug Administration's 2018 final guidance for the repackaging of biologics -- "Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application."
"Access to safely compounded Avastin is essential to the care of millions of Americans in preserving their vision," said Rahul N. Khurana, MD, Partner at Northern California Retina Vitreous Associates in Mountain View, California.
The 2018 final guidance sets forth FDA's policy regarding the mixing, diluting and repackaging of certain types of biologics outside an approved biologics license application (BLA), including the repackaging of Avastin. The final guidance requires 503B outsourcing facilities to repackage in accordance with cGMP and perform specific stability indicating tests to establish the beyond use date (BUD) of repackaged biological products, as well as conduct specific batch release testing. The stability tests must be conducted by outsourcers to assure consistency with the approved labeling and must include appearance, color and clarity, visible particulates, pH, sub-visible particles (per USP Chapter <788>, Particulate Matter for Injections or USP Chapter <789>, Particulate Matter for Ophthalmic Solutions, whichever is appropriate for route of administration), protein content, impurities, potency and sterility. The full guidance can be reviewed at FDA.gov.
In response to FDA guidance, Leiters launched an extensive development process to meet the elevated requirements governing the repackaging of Avastin. "Because repackaged Avastin is used as an ophthalmic solution for injection, our development focused on meeting the more stringent requirements of USP CH <789>," said Chris Zuccarelli, Chief Operating Officer of Leiters.
"Leiters invested significant resources in developing the necessary manufacturing processes and testing methodology to comply with the latest FDA requirements for the repackaging of Avastin," said Leiters Chief Executive Officer Robin Smith Hoke. "At Leiters, we strive to meet or exceed regulatory requirements – through a combination of diligence, innovation and integrity – our ophthalmic customers should have complete confidence in the repackaged Avastin products they need to treat their patients."
"I recently had the opportunity to visit the Leiters facility in San Jose, California. I was impressed with their quality processes and the expertise and dedication of their team. As a physician it gives me peace of mind knowing that I have such a reliable source for compliant repackaged Avastin that I can trust," said Tanya Ghosh, MD, Medical Retina; Munnerlyn Eye Institute, Palo Alto Medical Foundation in Sunnyvale, California.
Leiters, a trusted FDA-registered 503B outsourcing provider of high quality ophthalmology and hospital-based services, is committed to providing healthcare professionals and their patients with high quality medications. Leiters employs a team of sterile pharmaceutical manufacturing, repackaging, and pharmacy experts that bring a sophisticated understanding of what it takes to elevate quality and consistency of supply in outsourcing. By combining a quality team, robust processes and state-of-the art outsourcing facilities, Leiters ensures delivery of the highest quality products and services. Please visit www.leiters.com to understand how standards have been elevated in pharmaceutical outsourcing.