DESCRIPTION
The Mission of Medical Countermeasure Systems (MCS) — Platforms for Rapid Integrated Solutions for Medical Countermeasures (PRISM) is to apply proven platform technology to streamline Medical Countermeasure (MCM) delivery to the warfighter by accelerating development to licensure and employ platform technologies to support a rapid response capability to novel and emerging threats. The Advanced Development and Manufacturing of Antibody Technologies (ADAMANT) Monoclonal antibodies (mAb) platform can respond to recognized, emerging and engineered threats, provide interim fielding candidates early in development, and cost effectively bring mAb MCMs from discovery to licensure and fielding.
ADAMANT is being established at the Department of Defense (DOD) Advanced Development and Manufacturing (ADM) Facility. The first product for ADAMANT will be Botulinum toxin prophylactic and therapeutic mAb MCM. The goal is for monoclonal antibodies to be produced for biodefense applications at the DOD ADM, formulated for intermuscular use and lyophilized for cold chain avoidance and stockpiling.
BENEFIT TO THE SOLDIER
MCS PRISM accelerates MCM delivery to the warfighter through the development and implementation of platform systems. It also adapts a subset of the platform technologies to support a rapid response capability to novel and emerging threats.
SPECIFICATIONS
DOD Chemical, Biological Defense Program Planning Guidance for Fiscal Year 2019-2029 Joint Science and Technology Office and JPEO CBRND: continue to develop the PRISM concept through translational teaming and begin establishment of up to three additional platforms. Platforms should have broad applicability across the threat landscape, have mature discovery and design process, be supported by a robust manufacturing process and have demonstrated regulatory success with Food and Drug Administration approval of similar products
PROGRAM STATUS
1QFY18: ADAMANT Establishment (First Platform): Botulinum neurotoxins (BoNT) serotypes A, B Advanced Technology Demonstration – Stage 3 Technical Scope Approval – current Good Manufacturing Practices manufacturing and stability testing of anti-BoNT A|B drug substance and lyophilized drug product
PROJECTED ACTIVITIES
FY19-FY23:
- ADAMANT BoNT A|B Stage 4 Go/No Go Decision
- ADAMANT Platform Validation (Plague)
- DNA Vaccine Platform Establishment/Validation
- Initiate 3rd Platform Technology
- Establish ADAMANT Rapid Response Capability
