Healthpoint Biotherapeutics will begin construction in mid-2012 on a renovation of its 80,000-sf research and manufacturing campus in Fort Worth, Texas. The new facilities will comprise 25,000 sf of advanced manufacturing infrastructure, laboratories, and clean rooms for the production of cell-based therapies. Healthpoint will invest approximately $60 million to build out and staff the research and manufacturing facility over the next few years.
The project will be delivered in two phases to coincide with current pipeline requirements. The first phase will include advanced tissue processing capabilities, master cell banking, production of clinical supplies for phase III trials, and process development to support future manufacturing scale-up. Important features of the second, commercialization phase include automated closed system cell culturing, automated vial filling, and the use of radio frequency identification (RFID) technology allowing efficient, robotic packaging in -80 degrees Celsius freezers and product traceability in sealed dry ice shippers.
The first phase is anticipated to be operational by year-end 2012. Full validation and commissioning of the facility to release product for clinical trials is expected in 2013. Completion of the second phase will be timed to meet manufacturing and commercialization requirements, following regulatory approvals.
