EyePoint Pharmaceuticals, a US-based pharmaceutical company, will expand its laboratory and manufacturing capabilities with the construction of a new, custom-built commercial manufacturing facility in Northbridge, Massachusetts.
The facility will support the global production of the company’s programmes, including EYP-1901, an investigational sustained delivery treatment for wet age-related macular degeneration (wet AMD), and YUTIQ®, a fluocinolone acetonide intravitreal implant for chronic non-infectious uveitis treatment.
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The facility is being constructed and managed by V E Properties IX. In January 2023, EyePoint Pharmaceuticals signed a lease agreement with V E Properties IX to design and construct the facility according to the company’s specifications. The lease will have an initial term of 15 years and four months, upon the lease commencement date.
The state and local governments have shown support for the initiative by providing a $1.9m grant to assist in the establishment of the facility. The lease payments are scheduled to start after the completion of construction.
The facility is expected to be operational in the second half of 2024.
Location of EyePoint Pharmaceuticals’ cGMP manufacturing facility
The manufacturing facility will be located at 600 Commerce Park Drive in Northbridge, Massachusetts, US.
Eyepoint Pharmaceuticals’ cGMP manufacturing facility details
The state-of-the-art 40,000ft² facility will significantly enhance EyePoint’s manufacturing capacity, accelerating the clinical development and future commercial production of EYP-1901. It will support EYP-1901’s clinical supply and commercial readiness upon regulatory approval.
It will also support the global demand for YUTIQ, which has been approved by the US Food and Drug Administration (FDA) and China National Medical Products Administration (NMPA).
Designed to be Good Manufacturing Practice (GMP)-compliant, the facility will meet the stringent standards set by the FDA and European Medicines Agency (EMA).
The facility will be tailored to meet the unique requirements of the company’s development and manufacturing initiatives related to its expanding pipeline. The building will include clean manufacturing space, support and research labs, warehouse space, and office areas.
It will feature ten production suites for clinical supply and commercial-scale manufacturing, and laboratory support space, all built to ISO 7 clean room standards. It will include areas dedicated to quality control (QC), quality assurance (QA), and administrative functions.
EYP-1901 and Durasert platform technology
EYP-1901 combines a bioerodible formulation of EyePoint’s proprietary Durasert® delivery technology with vorolanib, a tyrosine kinase inhibitor licensed to EyePoint exclusively by Equinox Sciences for the localised treatment of all ophthalmic diseases.
The Durasert technology allows for sustained intraocular drug delivery, including that of EYP-1901. The Durasert drug delivery platform has been safely administered to thousands of patients’ eyes across four FDA-approved products, including YUTIQ®.
Contractors involved
Jones Lang LaSalle (JLL), a US-based real estate services company, has been involved in EyePoint’s property search, selection, and lease negotiation process.
Gorman Richardson Lewis Architects (GRLA), which offers comprehensive architecture, planning, and sustainable design services, is the lead architect for the project and is working in collaboration with construction manager RP Masiello, process engineers RemTech, and Phoenix Engineering to bring the facility to readiness.
American firm RP Masiello, known for its design and construction management expertise, has been selected to lead the design and construction.
Marketing commentary on EyePoint Pharmaceuticals
EyePoint Pharmaceuticals, employing approximately 51 to 200 employees, is dedicated to the development and commercialisation of innovative therapeutics for enhancing the lives of patients with severe eye disorders. The expertise spans ophthalmology, glaucoma, wet AMD, optometry, eye disease, and retinal disease.
EyePoint Pharmaceuticals creates new treatments and sustained-release drug delivery systems for a variety of challenging conditions, including macular degeneration, which is the leading cause of vision loss among adults, and other localised, chronic conditions.
EyePoint Pharmaceuticals has a portfolio of approved technologies such as Verisome® and Durasert® (Durasert E™: bioerodible, Durasert non-erodible), which are used to deliver novel drugs and repurpose existing molecules for new applications.
