New ABSL-3 Facility Draws Biodefense and Infectious Disease Research

IITRI has nearly tripled the size of its Biosafety Level 3 (BSL-3) facility. The vision for the buildout was not only to increase space for in vitro studies, but also to construct a BSL-3 facility for animal research and aerosolization studies. The 2300 square foot buildout includes three Animal Biosafety Level 3 (ABSL-3) laboratories and two in vitro laboratories, which can be used interchangeably. The largest room in the facility is configured for bioaerosol challenge.

Organisms studied in BSL-3 conditions are those pathogens that can cause serious or lethal disease by the inhalation route. Many of these pathogens are also called "Select Agents," defined by the U.S. government as biological agents that can be used for bioterrorism. Given the inhalation risks associated with these agents, a superior containment design and sophisticated air-handling system were critical for the BSL-3 laboratories.

The completion of four critical phases over approximately three years brought the expansion project to life: construction, commissioning, regulatory approval, and personnel training.

Construction: Containment is the Key

The design and construction of the new state-of-the-art facility at IITRI play a crucial role in providing environmental and personnel safety. The facility itself consists of a stainless steel labyrinth of well-contained laboratories. Facility entry doors are electronically controlled to prohibit simultaneous opening. All of the rooms are kept under increasingly negative pressure; areas containing infectious materials remain under the most negative pressure. Each room within the facility has a pressure differential indicator above each door, and employees are trained to glance at the indicator to confirm proper directional airflow prior to entering a room.

The directional airflow created by the negative pressure differentials ensures that the laboratory air travels single-pass in one direction and never gets out of the laboratories into the surrounding areas. Rather, air travels out of the facility by an exhaust system and through several high-efficiency particulate air (HEPA) filters. Even the animal caging system is designed with HEPA filtration for incoming and exiting air. Furthermore, the facility is designed so that if the exhaust system shuts down, the supply air will shut down as well, thereby preventing positive pressurization of the laboratories.

Final Stages: Commissioning and Regulatory Approval

Once construction was completed, facility commissioning was performed by an outside engineer who conducted a series of exercises to verify that the facility operated according to the strict ABSL-3 design specifications. All security and safety measures were fully tested, adjusted if needed, and determined to be compliant. A commissioning report was prepared, and the facilities were then inspected by the Centers for Disease Control and Prevention (CDC) and the United States Department of Agriculture (USDA) for regulatory approval and registration. IITRI's Select Agent registration now reflects the ability to perform both in vitro and in vivo work in this new facility.

Going "Hot": Personnel Training

	Laboratory staff, equipped in full PPE, working in the facility

The final phase in bringing the new facility on-line was training the laboratory staff in operational, procedural, and security requirements. Personnel training is of paramount importance to operation of the ABSL-3 facility. Staff members are fully trained in procedures for handling infectious materials, the use of personal protective equipment, and facility entry and exiting procedures. The laboratory staff also participates in regular training sessions in site security and safety. Additionally, all personnel who work in the ABSL-3 facility must undergo a background check and have a security approval.

National Contribution

IITRI is a member of the Great Lakes Regional Center of Excellence (GLRCE), one of 10 Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases (RCEs) created by the National Institute of Allergy and Infectious Diseases (NIAID) to decentralize and increase biodefense research at industrial and academic institutions nationwide. With the recent government push for increased biodefense research, IITRI is positioned to obtain new private and government-funded contracts. Pharmaceutical and biotechnology companies seeking to invent new vaccines and anti-infectives require facilities such as IITRI's ABSL-3 facility to test their products. As a Good Laboratory Practices (GLP) facility, IITRI is able to test products for future licensing, whereas most academic institutions cannot. IITRI has the capability to perform studies within any area of biodefense research in its ABSL-3 and BSL-3 facilities. The new ABSL-3 facility now provides the opportunity for conducting in vivo studies. Studies in the new facility began in October 2006, and currently focus on in vivo vaccine potency testing. Anticipated future studies include in vivo assessments of anti-infective drug therapies and the development of disease models following aerosol exposure.

According to Margaret Juergensmeyer, Ph.D., Research Biologist in IITRI's Microbiology and Molecular Biology Division, "We have an advantage in that we are willing to modify techniques and protocols to serve anybody." The highly trained infectious disease research scientists at IITRI are flexible and have the facilities to accommodate a vast array of in vivo and in vitro testing for BSL-3 pathogens, not only for biodefense research, but also for general infectious disease modeling such as confirmatory, validation, antibiotic, anti-microbial and prophylactic treatment testing.

Crucial Science With Global Effect

It is important to remember that work done in an ABSL-3 facility such as IITRI's not only combats bioterrorism and threats to public health for people living in the United States, but also aids the global population that encounters infectious disease more often. Many of the organisms tested in BSL-3 facilities are more common infections in animals than in humans—they are more likely to kill horses, cattle, or chickens. When Americans think of anthrax, it is usually in the context of bioterrorism; however, an anthrax outbreak in Africa may mean the loss of precious livestock. Anthrax, tularemia, glanders, plague—are all perfectly natural organisms that kill people and livestock everyday in Africa, Asia, Europe and even some places in the U.S. Louis Holland, Ph.D., Assistant Vice-President and Manager of IITRI's Microbiology and Molecular Biology Division, sums up the global contribution the ABSL-3 expansion accomplishes, asserting that it "provides us with a facility to help in the development of treatments that can prevent some of the most serious infections of mankind."