The Defense Biological Product Assurance Office (DBPAO), a component of the Joint Program Executive Office for Chemical and Biological Defense, has announced the development of a Biological Select Agents and Toxins (BSAT) surrogate solution that will mitigate the risks associated with shipment and use of Bacillus anthracis.

In addition to risk mitigation for Department of Defense (DoD) stakeholders and the community at large, this product demonstrates DBPAO’s commitment to providing quality reagents to the DoD and to the biodefense community.

In 2015, former Secretary of the Army (SECARMY), John McHugh, placed a moratorium on the production, shipment, and handling of any live or inactivated BSAT or BSAT derivative at Dugway Proving Ground and subsequently extended the moratorium to all other DoD laboratories and facilities.

McHugh’s successor, former SECARMY Eric Fanning, issued Army Directive 2016-24 (Department of Defense Biological Select Agent and Toxins Biosafety Program) in July 2016, assigning responsibilities and functions of the DoD BSAT Program to the Army Surgeon General allowing the resumption of production, shipment, and handling of non-BSAT materials. Under this mandate, the DBPAO assumed the responsibility of exploring alternatives to substitute for BSAT and BSAT-related products that mitigate hazards associated with their use.

To accomplish this task, the DBPAO developed a Bacillus anthracis surrogate strain named Recombinant Bacillus anthracis with Assay Targets (rBaSwAT) using a recombinant DNA approach to create a BSL-2-level genetically modified organism that will allow continuation of operations with reduced risk.

The strain is built in a novel, non-virulent Bacillus anthracis background and carries a comprehensive complement of anthrax specific molecular and immunological markers.

Even though rBaSwAT has the required markers to replace Bacillus anthracis in operations, it remains non-virulent. rBaSwAT was developed specifically for this effort, is user specific and may not work for all end-users. However, it may be further modified with additional or alternate user-specific assay signatures to create a panel of non-virulent strains relevant to current DBPAO costumers.

These modified novel Bacillus anthracis strain panels can be used as a surrogate for Bacillus anthracis by end users in a variety of applications.

Dr. Shanmuga Sozhamannan, the technical coordinator of the DBPAO as well as the driving force behind the DBPAO surrogate solution, led the following team of government scientists who proved integral to the success of this solution:

Naval Medical Research Center

Contribution: Design of the construct; assay testing; spore inactivation; and final product validation.

Dr. Joan Gebhardt

Dr. Mark Munson

United States Army Medical Research Institute of Infectious Disease

Contribution: Animal study and characterization.

Dr. Chris Cote

Dr. Dave Rozak

Dr. Terry Abshire

Edgewood Chemical Biological Center

Contribution: Whole genome sequencing.

Dr. Cory Bernhards

Dr. Nicole Rosenzweig

Ms. Rebecca Rossmaier

Ms. Tracey Biggs

Naval Surface Warfare Center

Contribution: Spore production and bridging studies.

Dr. Tony Buhr

Dr. Linda Beck

Dr. Andrea Staab

Food and Drug Administration

Contribution: Genetic manipulation and strain construction.

Dr. Roger Plaut

Dr. Scott Stibitz

The rBaSwAT surrogate, developed by the DBPAO, is an innovative solution that represents the future of the DBPAO’s approach to mitigate the risks associated with inactivated, virulent pathogens. A scientifically proven alternative to the use of Bacillus anthracis, this surrogate solution will provide significant hazard reduction in research, development, and testing initiatives.

In addition, surrogate use has the potential to reduce costs by eliminating the burdens associated with safely and securely shipping and using BSAT. rBaSwAT is the first step by the DBPAO to provide surrogate solutions for BSAT use that will reduce the costs and mitigate the risks for the DoD and all DBPAO customers.

The rBaSwAT surrogate is available through the DBPAO Ordering System for Assays and Reagents (OSCAR).