U.S. DoD Opens Advanced Biologics Manufacturing Facility For Private, Public Use

By Tim Belski, Joint Product Director, Advanced Development and Manufacturing Capabilities, U.S. Department of Defense

The U.S. Department of Defense (DoD) took an important step in protecting the nation from biological threats on Dec. 7, 2016, when it opened the first dedicated advanced manufacturing facility capable of developing and making biological products that will protect service members who may be exposed to biological weapons or natural threats.  

DoD’s pursuit of such a facility began in December 2010, following a memorandum from John O. Brennan, then Assistant to the President for Homeland Security and Counterterrorism, to Secretary of Defense Robert M. Gates: “Establish agile and flexible advanced development and manufacturing capabilities to support the development, licensure, and production of medical countermeasures that address the needs of our military and the nation.”

Subsequent research and development resulted in the establishment of a new state-of-the-art facility known as DoD Medical Countermeasures Advanced Development and Manufacturing (MCM ADM), which is now open for public and private business, in Alachua, Florida (outside of Gainesville).

Unique Challenges

The DoD MCM ADM and the business arrangements that support it were created by DoD’s Joint Project Manager Medical Countermeasure Systems (JPM-MCS). JPM-MCS’ mission is to provide U.S. military forces — and the nation — with safe, effective, and innovative medical solutions to counter chemical, biological, radiological, and nuclear threats.

The first step for the project was to define a new manufacturing capability specifically for DoD medical countermeasures. Understanding that the White House’s specified requirements would be challenging to meet, DoD conducted research to gain expertise in the detailed capabilities needed for the task and in the best business arrangement for the facility.

A priority during research was determining the biosafety level needed to ensure that the facility could properly handle and contain potentially dangerous products. It was found that the development and manufacture of some medical countermeasures — vaccines, antiviral drugs, antitoxins, and monoclonal antibodies — to combat threats require a biosafety level 3 (BSL-3)-capable facility, a very high safety standard.

Public-Private Partnerships

DoD research also determined that a successful facility would leverage the development expertise of large biopharmaceutical corporations while retaining the innovative spark possessed by many smaller biotech companies. This meant that any business arrangement must be attractive to private industry partners seeking a return on their investments, be able to support DoD surges in the event of an emergency, and support DoD’s development of medical countermeasures at smaller volumes when appropriate. Furthermore, because intellectual property (IP) is the lifeblood of pharmaceutical and biotechnology companies, business arrangements at the facility must also ensure IP protection.

DoD MCM ADM is therefore designed as a contractor-owned, contractor-operated enterprise with public surge privileges in times of national security needs. Given this framework, in March 2013, DoD awarded a $365 million, 10-year contract to Nanotherapeutics Inc., a privately owned biopharmaceutical company. Ground was broken just seven months later, in October 2013.

The building and operational partnership with Nanotherapeutics was expressly crafted to enable DoD to manufacture medical countermeasures before U.S. service members are affected by biological threats. Both parties hope to work with a wide range of pharmaceutical partners who will be attracted to the facility’s state-of-the art design.

Through partnering with Nanotherapeutics,  small innovator companies have the opportunity to leverage the state-of-the-art facility of the DoD MCM ADM.  These partnerships ensure that small innovators can gain access to expertise and technology that will help them navigate the complex processes and challenges of medical countermeasure development and production.

Unique Features

DoD MCM ADM is a flexible multiproduct/multipurpose current good manufacturing practice (cGMP) compliant facility with 180,000 square feet of space for biologics manufacturing and development. With four production lines, manufacturing can happen more quickly and more effectively than most other operations. It is also large enough to support a broad range of potential product platforms. DoD MCM ADM offers a cost-effective and integrated manufacturing infrastructure to both support industry needs and fulfill DoD’s medical countermeasure pipeline and surge requirements.

The facility meets DoD needs for early process development that provides flexibility and agility by:

• Enabling the rapid conversion of new product suites and their adaptability to customer demands
• Supporting bench-scale early process working volumes ranging from 4.5L to multiple 1000L lines
• Handling a wide variety of expression platforms

It also reduces the costs and time needed for product development by:

• Employing single-use technology where feasible, increasing annual production (compared with fixed stainless steel equipment) due to faster batch changeover procedures that result in shorter batch production times
• Supporting the small- to moderate-sized production that is characteristic of DoD needs, offsetting the costs of large manufacturing scale-up and technology transfer
• Shrinking the average time between runs by reducing facility downtime for cleaning and for the setup of regulatory-compliant manufacturing lines
• Allowing for continuous production, instead of the time-consuming clean- and steam-in-place validation and qualification of other facilities

Today’s DoD MCM ADM laboratory also has special engineering and design features that meet BSL-3 standards:

• A BSL-3-capable, cGMP-compliant manufacturing core, constructed as a modular clean room
• Four process rooms under negative pressure
• HEPA-filtered exhaust air
• Steam decontamination autoclaves with vaporized hydrogen peroxide (VHP) capabilities
• Biowaste kill systems
• Chlorine dioxide room decontamination
• A BSL-3-capable process development laboratory and pilot plant
• An advanced 24-hour integrated security system that provides an additional layer of safety

IP Protection

DoD MCM ADM is committed to IP protection that will support innovators of all sizes, ensuring that all partners’ products will be safeguarded throughout the manufacturing process and during all other early and advanced development support efforts.

Nanotherapeutics and its partners also have established IP management policies and plans detailing comprehensive means for ensuring IP protection. These guiding documents and supporting procedures are based on Nanotherapeutics’ extensive track record working with industry and with government agencies, such as DoD, the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority, and the National Institutes of Health.

In addition to biologics manufacturing and process development capabilities, Nanotherapeutics and its partners can quickly provide existing facilities, equipment, and expertise to support small-molecule manufacturing and clinical, nonclinical, and regulatory activities associated with the development of medical products.

Working with the DoD ADM

Nanotherapeutics and DoD are currently meeting with prospective partners who would like to use the facility. For more information on DoD MCM ADM and its capabilities, prospective pharmaceutical partners may contact me at timothy.t.belski.civ@mail.mil.

About the Author:

Tim Belski is the joint product director for the Advanced Development and Manufacturing Capabilities (ADMC) within the Medical Countermeasure Systems Joint Project Management Office (MCS-JPMO), headquartered at Fort Detrick, MD. In this role, he leads a team to establish the Department of Defense’s dedicated capability that will rapidly develop and produce medical countermeasures to counter known or unknown chemical, biological, radiological, and nuclear threats. These threats include novel and previously unrecognized emerging infectious diseases that occur naturally. A native of Pittsburgh, Belski graduated from Westminster College with a bachelor’s degree in environmental science. He also earned a master’s degree in biotechnology from The Johns Hopkins University. Tim is a member of the Army Acquisition Corps and has achieved Level III certification in science and technology management, and Level III certification in program management through the Defense Acquisition University.

Image credits: Photo of the DoD MCM ADM facility courtesy of Carol Meyhoefer, Silk Bandana Studios; photo of Tim Belski courtesy of the U.S. Department of Defense