A new ‘nano’ manufacturing facility to be located in Florida state is featured in a November 25, 2013 news item on Azonano,
Nanotherapeutics, Inc. announced today that on November 20, 2013, the Company held a Type C meeting with the U.S. Food and Drug Administration (“FDA”), providing an opportunity for the FDA 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 its cGMP [Current Good Manufacturing Practice] 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. The Company expressed its appreciation to the FDA for granting the meeting, which represents the achievement of a major milestone in the ongoing design of a successful NANO-ADM Center.
Current Good Manufacturing Practices (cGMPs) for human pharmaceuticals affect every American. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. Most people, however, are not aware of cGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives. Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of cGMPs. This paper discusses some facts that may be helpful in understanding how cGMPs establish the foundation for drug product quality.
What are cGMPs?
cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities….
Prior to this latest announcement about the NANO-ADM, there was some information offered in the company’s Oct. 23, 2013 news release about the groundbreaking event,
Nanotherapeutics, Inc. today announced that a groundbreaking ceremony for its Advanced Development and Manufacturing Center (NANO-ADM) in Copeland Park, Alachua, FL, will be held this morning [Oct. 23, 2013] at 9:00 am ET. …
The ceremony celebrates the groundbreaking of the 30-acre NANO-ADM center being constructed through privately secured financing to fulfill the contract awarded to Nanotherapeutics by the US Department of Defence (DOD) earlier this year. … The goal of the contract is to enable faster and more effective development of medical countermeasures designed to treat and protect military populations against chemical, biological, radiological and nuclear attacks and outbreaks of naturally occurring, emerging and genetically engineered infectious diseases.
Nanotherapeutics and its network of 16 world-class teaming partners and collaborators for this project are currently able to furnish core services in response to the DOD’s requirements, should the need arise. … single-use equipment of one-of-a-kind, 165,000 square foot facility. The NANO-ADM Center will integrate new biomanufacturing technologies with existing capabilities enabling the development of both small molecule and biologic products. …
The Nov. 21, 2013 news release, which originated the news item on Azonano, provided this additional detail,
Construction of the NANO-ADM Center is scheduled for completion in early 2015, with commissioning, qualification and full occupancy expected by mid-March 2015.
It seems to me that while New York State has garnered a lot of attention for its nanotechnology model, as evidenced by a book on the topic: New York’s Nanotechnology Model: Building the Innovation Economy: Summary of a Symposium (2013), and much more, Florida has been quietly establishing itself as another center for nanotechnology and innovation.