Massachusetts-based radiopharmaceutical product supplier, Pharmalucence, is constructing a new pharmaceutical manufacturing facility at Billerica in Massachusetts, US.
The facility is intended to modernise production assets for use in the production of Pharmalucence radiopharmaceutical products and to support the company’s continued expansion in aseptic fill and finish contract services.
The facility is designed to address scale, from small clinical trials up to full commercial scale production to clients worldwide.
It will also serve as the company headquarters. Investment on the facility is estimated to be $30m.
The first phase of construction started in the second quarter of 2011.
The construction will be fully completed by mid-2012.
Full drug production is expected to start by mid-2013.
The new facility will employ approximately 100 full time positions, including 25 new ones. During the construction phase, it is expected to create up to 150 construction jobs.
The new facility will consolidate the company’s current operations based in four buildings at a single site. Pharmalucence currently leases a 45,000ft2, four-building complex on DeAngelo Drive in Bedford staffed by 85 people. Pharmalucence was established through a management buy-out of CIS-US in 2007.
Pharmaceutical manufacturing facility specifications
The facility will span 70,000ft2 at 29 Dunham Road. The property was acquired for $2.7m from RREEF in December 2010.
It will feature state-of-the-art automation and employ barrier isolation and equipment from Robert Bosch Packaging. Pharmalucence has chosen to implement what it believes is the most advanced approach to aseptic processes, with an eye towards the highest levels of regulatory compliance.
Pilgrim Software is providing information technology to allow Pharmalucence to advance from a manual to a fully automated compliance system.
The facility will be modular and is designed to accommodate two automated suites featuring barrier isolation. The first suite can automatically feed two 180ft2 lyophilisers.
Once this system becomes operational, Pharmalucence intends to build a second suite that will be equipped to handle highly potent compounds. This second suite will mirror the design of the first, but share no infrastructure that would compromise the full separation of the high potency operation. The second suite will also feed two similarly sized lyophilisers.
Production of the Billerica plant
The facility will provide manufacturing for the entire Pharmalucence product pipeline. Pharmalucence manufactures vivo imaging agents used to diagnose and treat cancer and heart diseases. The facility will also undertake contract manufacturing services.
Financing Pharmalucence’s project
The project has been financed by a mix of federal, state and local funding as well as tax incentives.
To facilitate the expansion a $20m first recovery zone facility bond, a federally authorized tax-free bond was issued by MassDevelopment on behalf of Pharmalucence. The bond, which equals two-third of the total project cost, was bought by TD Bank.
Contractors involved in the pharmaceutical manufacturing facility project
The contract for the facility’s architectural design, engineering and construction was awarded to integrated project services (IPS) in June 2011. IPS is a Pennsylvania based full-service engineering company.
Work on the project began in the third quarter of 2010 when the project plan was finalised and contractors and equipment vendors were selected.
The demolition of the property began in February 2011. By May 2011, the new filling line mock-up was constructed in Germany. The line design will be evaluated and refined by the third quarter of 2011.
By the end of 2011, the first phase of construction involving offices and labs will be completed and the second phase involving the production area will begin.
Partial occupancy of the facility is expected by late 2011. The first lyophiliser will be delivered towards the end of August.
The 2012 schedule includes factory testing and installation of facility infrastructure and utilities, factory testing, delivery and installation of the new filling line, factory testing, delivery and installation of secondary production equipment, facility start-up and validation.
Upon conclusion of validation of all systems, FDA inspection and approval must occur prior to engaging drug manufacture. Pharmalucence is working towards facility approval between the first and second quarter of 2013.