Gil Roth11.21.13
Nanotherapeutics has held a Type C meeting with the FDA. The meeting provided an opportunity for the agency to review and provide feedback on Nanotherapeutics’ plans for its Advanced Development and Manufacturing (NANO-ADM) Center facility to be located in Copeland Park, Alachua, FL.
The review and subsequent discussions with the FDA focused on the cGMP manufacturing space, which will provide Nanotherapeutics with capabilities to develop and produce bulk vaccines and biologics for the Department of Defense (DOD), other government agencies, and industry.
On March 20, 2013, the DOD awarded Nanotherapeutics, as prime contractor, a contract to provide all the core services necessary to establish a Medical Countermeasures Advanced Development and Manufacturing (MCM ADM) capability. Nanotherapeutics subsequently secured private financing to buy 30 acres of land and construct a 165,000-sq.-ft. NANO-ADM Center as its operational and manufacturing hub in Alachua. The goal of the contract is to enable a flexible, multi-product, multi-purpose facility based on single-use technology (SUT) for faster and more effective development and manufacturing of medical countermeasures designed to protect and treat military populations against chemical, biological, radiological and nuclear attacks and outbreaks of naturally occurring, emerging and genetically engineered infectious diseases.
A groundbreaking ceremony for the NANO-ADM Center was held on October 23, 2013. Construction of the NANO-ADM Center is scheduled for completion in early 2015, with commissioning, qualification and full occupancy expected by mid-March 2015.
The review and subsequent discussions with the FDA focused on the cGMP manufacturing space, which will provide Nanotherapeutics with capabilities to develop and produce bulk vaccines and biologics for the Department of Defense (DOD), other government agencies, and industry.
On March 20, 2013, the DOD awarded Nanotherapeutics, as prime contractor, a contract to provide all the core services necessary to establish a Medical Countermeasures Advanced Development and Manufacturing (MCM ADM) capability. Nanotherapeutics subsequently secured private financing to buy 30 acres of land and construct a 165,000-sq.-ft. NANO-ADM Center as its operational and manufacturing hub in Alachua. The goal of the contract is to enable a flexible, multi-product, multi-purpose facility based on single-use technology (SUT) for faster and more effective development and manufacturing of medical countermeasures designed to protect and treat military populations against chemical, biological, radiological and nuclear attacks and outbreaks of naturally occurring, emerging and genetically engineered infectious diseases.
A groundbreaking ceremony for the NANO-ADM Center was held on October 23, 2013. Construction of the NANO-ADM Center is scheduled for completion in early 2015, with commissioning, qualification and full occupancy expected by mid-March 2015.
