BIOLOGICAL DEFENSE – Additional Information That Congress May Find Useful as It Considers DOD’s Advanced Development and Manufacturing Capability, July 2017

Background

From the report:

DOD’s ADM facility is to specialize in manufacturing biologics, with a focus on producing antibodies and vaccines. Until recently, the manufacture of biologic medical countermeasures has required a single facility to produce a single product (e.g., a vaccine), and extensive cleaning and sterilization of equipment was required to switch from manufacturing one product to another. However, recent technological advancements have made “flexible manufacturing” possible. These
technologies include the use of disposable equipment, such as equipment for growing cell cultures in disposable plastic material systems rather than in stainless steel tanks that require more time to clean and sterilize prior to the next use, and the use of modular sterile rooms to allow for the manufacture of multiple products simultaneously within a given facility. In the advanced research and development stage, potential medical countermeasures are further evaluated to demonstrate their safety and efficacy for preventing, diagnosing, or treating disease. Successful products are then available for final development and procurement.

As we reported in 2014, DOD is one of several agencies, along with HHS, involved in addressing and countering biological threat agents. As illustrated in figure 1, both DOD and HHS have specific biological medical countermeasure needs, some of which are shared.