The Preventive Medical Countermeasures (PMCM) Program accelerates innovation in the development and manufacturing of next generation vaccine and drug product modalities. The Program brings NIIMBL members and federal partners together to address common challenges in analytics, product understanding, and drug product manufacturing where shared knowledge and coordinated solutions benefit the broader biopharmaceutical community.
Enable rapid, consistent, and scalable manufacturing of emerging preventive medical countermeasure platforms by advancing analytical understanding, improving process robustness, and creating data and tools that support industry adoption.
A biopharmaceutical ecosystem equipped with platform ready analytics, harmonized practices, and adaptable manufacturing approaches that accelerate time to clinic and time to market for high quality preventive medical countermeasures.
Preventive medical countermeasures include a broad set of vaccine and drug‑product modalities designed to protect public health. As existing platforms evolve and new platforms emerge, the industry must understand how product attributes relate to performance, stability, manufacturability, and process capability. PMCM addresses this need by generating shared analytical insight, establishing more consistent development practices, and evaluating manufacturing operations that impact product quality and yield.
These efforts help organizations reduce development risk, improve process predictability, support regulatory alignment, and accelerate delivery of high‑quality products that respond to evolving public health threats.
The Analytical Characterization Workstream develops a deeper understanding of how mRNA‑LNP biophysical attributes relate to product performance and potency. The team evaluates LNP structure‑function relationships using industry‑relevant materials and applies comprehensive analytical tools – including fractionation, particle sizing, RNA integrity, lipid composition, and potency assays—to inform rapid and robust process development approaches.
Key Activities
The Sterile Filtration Workstream addresses the industry challenge of sterile filtration for mRNA‑LNP drug products. Because LNPs often overlap with filter pore size distributions and interact with filter materials, filtration can lead to fouling, limited throughput, and variable yields.
This workstream benchmarks industry practices, characterizes filtration behavior across filters and LNP attributes, and generates comparative data to define filtration design spaces and support future standards.
Key Activities
Objective: Develop a facility and equipment available for NIIMBL members to assess techniques and facilitate training and knowledge sharing
Workstream on Sterile Filtration launches
Analytical Characterization Workstream launches
Analytics Center of Excellence at NIIMBL HQ established, instrumented and staffed
Industry‑led Steering Committee established; monthly meetings begin
Preventive Medical Countermeasures Program Kickoff held at NIIMBL headquarters
AstraZeneca
Cytiva
EMD Millipore Corporation
Federal Stakeholder: National Institute of Standards and Technology
NIIMBL
Pfizer, Inc.
Sanofi
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