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Pharmaceutical Technology's In the Lab eNewsletter
The company expanded its extended workbench laboratory services program to support the ongoing manufacturing and development of Flexion Therapeutics’s Zilretta (triamcinolone acetonide extended-release injectable suspension).
Alcami’s recent expansion of its extended workbench laboratory services program will support the ongoing manufacturing and development of Zilretta (triamcinolone acetonide extended-release injectable suspension), an anti-osteoarthritis drug. Zilretta was developed by Flexion Therapeutics, a Massachusetts-based biopharmaceutical company. Alcami announced the completion of this expansion on June 13, 2018.
Alcami's extended workbench is a full-time equivalent comprehensive service program customized to a client’s specific project. The program assigns Alcami staff to a particular project, which grants clients additional flexibility, freedom, and consistent control over their outsourced laboratory needs, according to Alcami. The program can vary in size, management type, and scope, and can be effective across any pharmaceutical platform. The service has a fixed cost and can meet all necessary laboratory requirements, including method development and validation through to full quality-control support.
Flexion specialized in the development and commercialization of new, local therapies for the treatment of musculoskeletal conditions, beginning with osteoarthritis (OA). The company previously used Alcami’s extended workbench to support Zilretta from Phase II clinical trials through commercial launch and is using the program for the release and stability testing of commercial batches.
According to Alcami, Zilretta is the only FDA-approved extended-release intra-articular therapy for patients confronting OA-related knee pain. Zilretta employs proprietary microsphere technology combining triamcinolone acetonide-a commonly administered, short-acting corticosteroid-with a poly lactic-co-glycolic acid matrix to provide extended pain relief over 12 weeks.
Alcami states that it began work on Zilretta in the fall of 2014. Alcami helped Flexion meet FDA requirements during the new drug application review of Zilretta, which resulted in United States-approval of the drug’s treatment of OA-related knee pain in October 2017. The product was officially launched in November 2017.
“Our versatile [e]xtended [w]orkbench solution was an excellent fit for our partners at Flexion, whose accelerated timeline, robust clinical trial program, and specific testing requirements mandated dedicated laboratory resources to get their product to market,” said Alcami Chief Commercial Officer, Syed T. Husain, in a company press release.
“For the past four years, Alcami has been one of our most trusted collaborators,” said Mike Clayman, MD, president and CEO of Flexion, in the release. “They have been able to both respond to and anticipate our needs as Flexion has transitioned into a commercial organization, and we look forward to their ongoing support.”