Tag Archives: U.S. Food and Drug Administration

3D bioprinting: a conference about the latest trends (May 3 – 5, 2017 at the University of British Columbia, Vancouver)

The University of British Columbia’s (UBC) Peter Wall Institute for Advanced Studies (PWIAS) is hosting along with local biotech firm, Aspect Biosystems, a May 3 -5, 2017 international research roundtable known as ‘Printing the Future of Therapeutics in 3D‘.

A May 1, 2017 UBC news release (received via email) offers some insight into the field of bioprinting from one of the roundtable organizers,

This week, global experts will gather [4] at the University of British
Columbia to discuss the latest trends in 3D bioprinting—a technology
used to create living tissues and organs.

In this Q&A, UBC chemical and biological engineering professor
Vikramaditya Yadav [5], who is also with the Regenerative Medicine
Cluster Initiative in B.C., explains how bioprinting could potentially
transform healthcare and drug development, and highlights Canadian
innovations in this field.

WHY IS 3D BIOPRINTING SIGNIFICANT?

Bioprinted tissues or organs could allow scientists to predict
beforehand how a drug will interact within the body. For every
life-saving therapeutic drug that makes its way into our medicine
cabinets, Health Canada blocks the entry of nine drugs because they are
proven unsafe or ineffective. Eliminating poor-quality drug candidates
to reduce development costs—and therefore the cost to consumers—has
never been more urgent.

In Canada alone, nearly 4,500 individuals are waiting to be matched with
organ donors. If and when bioprinters evolve to the point where they can
manufacture implantable organs, the concept of an organ transplant
waiting list would cease to exist. And bioprinted tissues and organs
from a patient’s own healthy cells could potentially reduce the risk
of transplant rejection and related challenges.

HOW IS THIS TECHNOLOGY CURRENTLY BEING USED?

Skin, cartilage and bone, and blood vessels are some of the tissue types
that have been successfully constructed using bioprinting. Two of the
most active players are the Wake Forest Institute for Regenerative
Medicine in North Carolina, which reports that its bioprinters can make
enough replacement skin to cover a burn with 10 times less healthy
tissue than is usually needed, and California-based Organovo, which
makes its kidney and liver tissue commercially available to
pharmaceutical companies for drug testing.

Beyond medicine, bioprinting has already been commercialized to print
meat and artificial leather. It’s been estimated that the global
bioprinting market will hit $2 billion by 2021.

HOW IS CANADA INVOLVED IN THIS FIELD?

Canada is home to some of the most innovative research clusters and
start-up companies in the field. The UBC spin-off Aspect Biosystems [6]
has pioneered a bioprinting paradigm that rapidly prints on-demand
tissues. It has successfully generated tissues found in human lungs.

Many initiatives at Canadian universities are laying strong foundations
for the translation of bioprinting and tissue engineering into
mainstream medical technologies. These include the Regenerative Medicine
Cluster Initiative in B.C., which is headed by UBC, and the University
of Toronto’s Institute of Biomaterials and Biomedical Engineering.

WHAT ETHICAL ISSUES DOES BIOPRINTING CREATE?

There are concerns about the quality of the printed tissues. It’s
important to note that the U.S. Food and Drug Administration and Health
Canada are dedicating entire divisions to regulation of biomanufactured
products and biomedical devices, and the FDA also has a special division
that focuses on regulation of additive manufacturing – another name
for 3D printing.

These regulatory bodies have an impressive track record that should
assuage concerns about the marketing of substandard tissue. But cost and
pricing are arguably much more complex issues.

Some ethicists have also raised questions about whether society is not
too far away from creating Replicants, à la _Blade Runner_. The idea is
fascinating, scary and ethically grey. In theory, if one could replace
the extracellular matrix of bones and muscles with a stronger substitute
and use cells that are viable for longer, it is not too far-fetched to
create bones or muscles that are stronger and more durable than their
natural counterparts.

WILL DOCTORS BE PRINTING REPLACEMENT BODY PARTS IN 20 YEARS’ TIME?

This is still some way off. Optimistically, patients could see the
technology in certain clinical environments within the next decade.
However, some technical challenges must be addressed in order for this
to occur, beginning with faithful replication of the correct 3D
architecture and vascularity of tissues and organs. The bioprinters
themselves need to be improved in order to increase cell viability after
printing.

These developments are happening as we speak. Regulation, though, will
be the biggest challenge for the field in the coming years.

There are some events open to the public (from the international research roundtable homepage),

OPEN EVENTS

You’re invited to attend the open events associated with Printing the Future of Therapeutics in 3D.

Café Scientifique

Thursday, May 4, 2017
Telus World of Science
5:30 – 8:00pm [all tickets have been claimed as of May 2, 2017 at 3:15 pm PT]

3D Bioprinting: Shaping the Future of Health

Imagine a world where drugs are developed without the use of animals, where doctors know how a patient will react to a drug before prescribing it and where patients can have a replacement organ 3D-printed using their own cells, without dealing with long donor waiting lists or organ rejection. 3D bioprinting could enable this world. Join us for lively discussion and dessert as experts in the field discuss the exciting potential of 3D bioprinting and the ethical issues raised when you can print human tissues on demand. This is also a rare opportunity to see a bioprinter live in action!

Open Session

Friday, May 5, 2017
Peter Wall Institute for Advanced Studies
2:00 – 7:00pm

A Scientific Discussion on the Promise of 3D Bioprinting

The medical industry is struggling to keep our ageing population healthy. Developing effective and safe drugs is too expensive and time-consuming to continue unchanged. We cannot meet the current demand for transplant organs, and people are dying on the donor waiting list every day.  We invite you to join an open session where four of the most influential academic and industry professionals in the field discuss how 3D bioprinting is being used to shape the future of health and what ethical challenges may be involved if you are able to print your own organs.

ROUNDTABLE INFORMATION

The University of British Columbia and the award-winning bioprinting company Aspect Biosystems, are proud to be co-organizing the first “Printing the Future of Therapeutics in 3D” International Research Roundtable. This event will congregate global leaders in tissue engineering research and pharmaceutical industry experts to discuss the rapidly emerging and potentially game-changing technology of 3D-printing living human tissues (bioprinting). The goals are to:

Highlight the state-of-the-art in 3D bioprinting research
Ideate on disruptive innovations that will transform bioprinting from a novel research tool to a broadly adopted systematic practice
Formulate an actionable strategy for industry engagement, clinical translation and societal impact
Present in a public forum, key messages to educate and stimulate discussion on the promises of bioprinting technology

The Roundtable will bring together a unique collection of industry experts and academic leaders to define a guiding vision to efficiently deploy bioprinting technology for the discovery and development of new therapeutics. As the novel technology of 3D bioprinting is more broadly adopted, we envision this Roundtable will become a key annual meeting to help guide the development of the technology both in Canada and globally.

We thank you for your involvement in this ground-breaking event and look forward to you all joining us in Vancouver for this unique research roundtable.

Kind Regards,
The Organizing Committee
Christian Naus, Professor, Cellular & Physiological Sciences, UBC
Vikram Yadav, Assistant Professor, Chemical & Biological Engineering, UBC
Tamer Mohamed, CEO, Aspect Biosystems
Sam Wadsworth, CSO, Aspect Biosystems
Natalie Korenic, Business Coordinator, Aspect Biosystems

I’m glad to see this event is taking place—and with public events too! (Wish I’d seen the Café Scientifique announcement earlier when I first checked for tickets  yesterday. I was hoping there’d been some cancellations today.) Finally, for the interested, you can find Aspect Biosystems here.

Use of nanomaterials in food for animals: the US Food and Drug Administration (FDA) issues a final guidance

Bureaucratese is not my first language so the US Food and Drug Administration’s final guidance on the use of nanomaterials in animal food seems a little vague to me. That said, here’s the Aug. 5, 2015 news item on Nanowerk, which announced the guidance (Note: A link has been removed),

The U.S. Food and Drug Administration has issued a final guidance for industry, ‘Use of Nanomaterials in Food for Animals’ (pdf), which is intended to assist industry and other stakeholders in identifying potential issues related to safety or regulatory status of food for animals containing nanomaterials or otherwise involving the application of nanotechnology. This guidance is applicable to food ingredients intended for use in animal food which (1) consist entirely of nanomaterials, (2) contain nanomaterials as a component or (3) otherwise involve the application of nanotechnology.

An Aug. 4, 2015 FDA announcement, which originated the news item, provides more detail,

This final guidance addresses the legal framework for adding nanomaterial substances to food for animals and includes recommendations for submitting a Food Additive Petition (FAP) for a nanomaterial animal food ingredient. This guidance also recommends manufacturers consult with FDA early in the development of their nanomaterial animal food ingredient and before submitting an FAP. At this time, we are not aware of any animal food ingredient engineered on the nanometer scale for which there is generally available safety data sufficient to serve as the foundation for a determination that the use of such an animal food ingredient is generally recognized as safe (GRAS).

Nanotechnology is an emerging technology that allows scientists to create, explore, and manipulate materials on a scale measured in nanometers – particles so small that they cannot be seen with a regular microscope. These particles can have chemical, physical, and biological properties that differ from those of their larger counterparts, and nanotechnology has a broad range of potential applications.

Guidance documents represent the FDA’s current thinking on particular topics, policies, and regulatory issues. While “guidance for industry” documents are prepared primarily for industry, they also are used by FDA staff and other stakeholders to understand the agency’s interpretation of laws and policies.

Although this guidance has been finalized, you can submit comments at any time. To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2013-D-1009 on each page of your written comments.

Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

You can find the guidance here.

Commercializing Titan Spine’s next generation spinal interbody fusion implant

The July 22, 2015 Titan Spine news release on BusinessWire is mainly focused on the appointment of a senior nanotechnology specialist; I’m more interested in the mention of product commercialization (first mentioned in my Nov. 26, 2014 post) in the fourth quarter of 2015,

Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced the appointment of Jim Sevey as the Company’s Senior Nanotechnology Specialist. The appointment follows the Company’s receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Endoskeleton® line of interbody fusion implants featuring its next generation nanoLOCKTM surface technology and precedes the Company’s full commercialization of the new line, planned for the fourth quarter of this year. The nanoLOCK™ surface represents the only FDA-cleared nanotechnology for spinal implant applications.

Mr. Sevey’s role will include leading the educational initiatives to further demonstrate and communicate the scientific evidence supporting the advantages of Titan Spine’s unique nanoLOCKTM surface technology. The surface features an increased amount of nano-scaled textures that result in the up-regulation of a greater amount of osteogenic and angiogenic growth factors critical for bone growth and fusion as compared to PEEK and the company’s current surface.1

Kevin Gemas, President of Titan Spine, commented, “As our body of science continues to grow, we identified the need to bring onboard someone of Jim’s caliber to educate the spinal surgeon community and our sales force on the science and associated benefits of our current and nanoLOCK™ proprietary surface technologies. With more than 22 years of experience with medical devices and biomaterials, Jim is the right person to lead these efforts. One of Jim’s initial tasks will be to clearly differentiate the science of our nanotechnology platform from those that claim to have nanotechnology but have not been cleared by the FDA to do so. We are proud to add Jim to our ever-growing scientific team.”

Barbara Boyan, Ph.D., Dean of the School of Engineering at Virginia Commonwealth University, and lead author of several studies supporting Titan Spine surfaces, added, “The spine industry is beginning to recognize ‘nanotechnology’ as more than a marketing concept and now as a design approach that has the potential to improve spinal fusion results for patients. Titan Spine has been at the forefront of this charge for nearly a decade, conducting studies to evaluate and refine the benefits of nanotechnology for interbody fusions. I look forward to working closely with Jim to further these efforts.”

Before joining Titan Spine, Mr. Sevey held several positions at Synthes/Depuy Biomaterials, including most recently, Manager, Biomaterials Technical Specialist. In this role, he generated multidivisional sales of osteobiologic product lines by providing clinical and technical consulting, training, and education for surgeons, residents, operating room personnel, and sales consultants. Prior to Synthes/Depuy Biomaterials, Mr. Sevey was part of the founding team of Skeletal Kinetics, LLC, (Cupertino, CA) as Director of Marketing. Mr. Sevey holds a Bachelor of Science in Health Science from St. Mary’s College of California (Moraga, CA).

The full line of Endoskeleton® devices features Titan Spine’s proprietary implant surface technology, consisting of a unique combination of roughened topographies at the macro, micro, and cellular levels. This unique combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting the up-regulation of osteogenic and angiogenic factors necessary for bone growth, encouraging natural production of bone morphogenetic proteins (BMPs), down-regulating inflammatory factors, and creating the potential for a faster and more robust fusion.2,3,4

About Titan Spine

Titan Spine, LLC is a surface technology company focused on the design and manufacture of interbody fusion devices for the spine. The company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. Titan Spine, located in Mequon, Wisconsin and Laichingen, Germany, markets a full line of Endoskeleton® interbody devices featuring its proprietary textured surface in the U.S. and portions of Europe through its sales force and a network of independent distributors. To learn more, visit www.titanspine.com.

Titan Spine Study References:

1 Olivares-Navarrete, R., Hyzy, S. L., Berg, M. E., Schneider, J. M., Hotchkiss, K., Schwartz, Z., & Boyan, B. D. Osteoblast Lineage Cells Can Discriminate Microscale Topographic Features on Titanium–Aluminum–Vanadium Surfaces.Ann Biomed Eng. 2014; 1-11.

2 Olivares-Navarrete, R., Hyzy, S.L., Slosar, P.J., Schneider, J.M., Schwartz, Z., and Boyan, B.D. (2015). Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors. Spine, Volume 40, Issue 6, 399–404.

3 Olivares-Navarrete, R., Gittens, R.A., Schneider, J.M., Hyzy, S.L., Haithcock, D.A., Ullrich, P.F., Schwartz, Z., Boyan, B.D. (2012). Osteoblasts exhibit a more differentiated phenotype and increased bone morphogenetic production on titanium alloy substrates than poly-ether-ether-ketone. The Spine Journal, 12, 265-272.

4 Olivares-Navarrete, R., Hyzy, S.L., Gittens, R.A., Schneider, J.M., Haithcock, D.A., Ullrich, P.F., Slosar, P. J., Schwartz, Z., Boyan, B.D. (2013). Rough titanium alloys regulate osteoblast production of angiogenic factors. The Spine Journal, 13, 1563-1570.

It’s unusual (and welcome) to see citations included with a business news release for a new medical device.

I didn’t think to pose the query in my last post but I wonder if Barbara Boyan has some sort of financial interest in Titan Spine? Her Virginia Commonwealth University faculty webpage suggests the answer is no,

Experience

  • Associate Dean for Research and Innovation in the College of Engineering at Georgia Institute of Technology
  • Professor and Price Gilbert, Jr. Chair in Tissue Engineering in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University
  • Deputy Director of Research at Georgia Tech and at the Emory Center for the Engineering of Living Tissues at the Georgia Institute of Technology
  • Professor and Vice Chair for Research in the Department of Orthopaedics at the University of Texas Health Science Center at San Antonio
  • Co-founder of Osteobiologics, Inc.
  • Founder and Chief Scientific Officer of SpherIngenics, Inc.
  • Member, Board of Directors, ArthroCare Corporation and Carticept Medical, Inc.

Still, I wish there was a statement that spelled out Boyan’s relationship or lack of with Titan Spine.

I sing the body cyber: two projects funded by the US National Science Foundation

Points to anyone who recognized the reference to Walt Whitman’s poem, “I sing the body electric,” from his classic collection, Leaves of Grass (1867 edition; h/t Wikipedia entry). I wonder if the cyber physical systems (CPS) work being funded by the US National Science Foundation (NSF) in the US will occasion poetry too.

More practically, a May 15, 2015 news item on Nanowerk, describes two cyber physical systems (CPS) research projects newly funded by the NSF,

Today [May 12, 2015] the National Science Foundation (NSF) announced two, five-year, center-scale awards totaling $8.75 million to advance the state-of-the-art in medical and cyber-physical systems (CPS).

One project will develop “Cyberheart”–a platform for virtual, patient-specific human heart models and associated device therapies that can be used to improve and accelerate medical-device development and testing. The other project will combine teams of microrobots with synthetic cells to perform functions that may one day lead to tissue and organ re-generation.

CPS are engineered systems that are built from, and depend upon, the seamless integration of computation and physical components. Often called the “Internet of Things,” CPS enable capabilities that go beyond the embedded systems of today.

“NSF has been a leader in supporting research in cyber-physical systems, which has provided a foundation for putting the ‘smart’ in health, transportation, energy and infrastructure systems,” said Jim Kurose, head of Computer & Information Science & Engineering at NSF. “We look forward to the results of these two new awards, which paint a new and compelling vision for what’s possible for smart health.”

Cyber-physical systems have the potential to benefit many sectors of our society, including healthcare. While advances in sensors and wearable devices have the capacity to improve aspects of medical care, from disease prevention to emergency response, and synthetic biology and robotics hold the promise of regenerating and maintaining the body in radical new ways, little is known about how advances in CPS can integrate these technologies to improve health outcomes.

These new NSF-funded projects will investigate two very different ways that CPS can be used in the biological and medical realms.

A May 12, 2015 NSF news release (also on EurekAlert), which originated the news item, describes the two CPS projects,

Bio-CPS for engineering living cells

A team of leading computer scientists, roboticists and biologists from Boston University, the University of Pennsylvania and MIT have come together to develop a system that combines the capabilities of nano-scale robots with specially designed synthetic organisms. Together, they believe this hybrid “bio-CPS” will be capable of performing heretofore impossible functions, from microscopic assembly to cell sensing within the body.

“We bring together synthetic biology and micron-scale robotics to engineer the emergence of desired behaviors in populations of bacterial and mammalian cells,” said Calin Belta, a professor of mechanical engineering, systems engineering and bioinformatics at Boston University and principal investigator on the project. “This project will impact several application areas ranging from tissue engineering to drug development.”

The project builds on previous research by each team member in diverse disciplines and early proof-of-concept designs of bio-CPS. According to the team, the research is also driven by recent advances in the emerging field of synthetic biology, in particular the ability to rapidly incorporate new capabilities into simple cells. Researchers so far have not been able to control and coordinate the behavior of synthetic cells in isolation, but the introduction of microrobots that can be externally controlled may be transformative.

In this new project, the team will focus on bio-CPS with the ability to sense, transport and work together. As a demonstration of their idea, they will develop teams of synthetic cell/microrobot hybrids capable of constructing a complex, fabric-like surface.

Vijay Kumar (University of Pennsylvania), Ron Weiss (MIT), and Douglas Densmore (BU) are co-investigators of the project.

Medical-CPS and the ‘Cyberheart’

CPS such as wearable sensors and implantable devices are already being used to assess health, improve quality of life, provide cost-effective care and potentially speed up disease diagnosis and prevention. [emphasis mine]

Extending these efforts, researchers from seven leading universities and centers are working together to develop far more realistic cardiac and device models than currently exist. This so-called “Cyberheart” platform can be used to test and validate medical devices faster and at a far lower cost than existing methods. CyberHeart also can be used to design safe, patient-specific device therapies, thereby lowering the risk to the patient.

“Innovative ‘virtual’ design methodologies for implantable cardiac medical devices will speed device development and yield safer, more effective devices and device-based therapies, than is currently possible,” said Scott Smolka, a professor of computer science at Stony Brook University and one of the principal investigators on the award.

The group’s approach combines patient-specific computational models of heart dynamics with advanced mathematical techniques for analyzing how these models interact with medical devices. The analytical techniques can be used to detect potential flaws in device behavior early on during the device-design phase, before animal and human trials begin. They also can be used in a clinical setting to optimize device settings on a patient-by-patient basis before devices are implanted.

“We believe that our coordinated, multi-disciplinary approach, which balances theoretical, experimental and practical concerns, will yield transformational results in medical-device design and foundations of cyber-physical system verification,” Smolka said.

The team will develop virtual device models which can be coupled together with virtual heart models to realize a full virtual development platform that can be subjected to computational analysis and simulation techniques. Moreover, they are working with experimentalists who will study the behavior of virtual and actual devices on animals’ hearts.

Co-investigators on the project include Edmund Clarke (Carnegie Mellon University), Elizabeth Cherry (Rochester Institute of Technology), W. Rance Cleaveland (University of Maryland), Flavio Fenton (Georgia Tech), Rahul Mangharam (University of Pennsylvania), Arnab Ray (Fraunhofer Center for Experimental Software Engineering [Germany]) and James Glimm and Radu Grosu (Stony Brook University). Richard A. Gray of the U.S. Food and Drug Administration is another key contributor.

It is fascinating to observe how terminology is shifting from pacemakers and deep brain stimulators as implants to “CPS such as wearable sensors and implantable devices … .” A new category has been created, CPS, which conjoins medical devices with other sensing devices such as wearable fitness monitors found in the consumer market. I imagine it’s an attempt to quell fears about injecting strange things into or adding strange things to your body—microrobots and nanorobots partially derived from synthetic biology research which are “… capable of performing heretofore impossible functions, from microscopic assembly to cell sensing within the body.” They’ve also sneaked in a reference to synthetic biology, an area of research where some concerns have been expressed, from my March 19, 2013 post about a poll and synthetic biology concerns,

In our latest survey, conducted in January 2013, three-fourths of respondents say they have heard little or nothing about synthetic biology, a level consistent with that measured in 2010. While initial impressions about the science are largely undefined, these feelings do not necessarily become more positive as respondents learn more. The public has mixed reactions to specific synthetic biology applications, and almost one-third of respondents favor a ban “on synthetic biology research until we better understand its implications and risks,” while 61 percent think the science should move forward.

I imagine that for scientists, 61% in favour of more research is not particularly comforting given how easily and quickly public opinion can shift.

Florida and its Advanced Development and Manufacturing (NANO-ADM) Center

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.

You can find out more about Nanotherapeutics, Inc. here and for anyone curious about cGMPs, there’s this page on the FDA website,

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.