Alcami Corporation, a provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biotechnology industries, has expanded deployment of its extended workbench laboratory services programme to support the ongoing manufacturing and development of zilretta (triamcinolone acetonide extended-release injectable suspension).
Zilretta is the first US Food and Drug Administration (FDA) approved product from Flexion Therapeutics, a Massachusetts-based biopharmaceutical company focused on the development and commercialisation of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis (OA).
Flexion utilised Alcami's extended workbench to support zilretta from phase II clinical trials through commercial launch and is using the programme for the release and stability testing of commercial batches.
Alcami's extended workbench is a full-time equivalent (FTE) comprehensive service programme customised to a client's specific project. It dedicates Alcami staff to a particular project, granting clients additional flexibility, freedom and consistent control of their outsourced laboratory needs.
The extended workbench can vary in size, management type and scope, and can be effective across any pharmaceutical platform. The fixed-cost service can meet every laboratory necessity, from method development and validation to full quality control support.
"Our versatile extended workbench 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 Syed T. Husain, Chief Commercial Officer, Alcami.
Dr Mike Clayman, President and CEO of Flexion said: "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."
Zilretta is the first and 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 (PLGA) matrix to provide extended pain relief for 12 weeks.
