There is a need for rapid and scalable access to plasmid DNA to support manufacturing of medical countermeasures and gene therapies. The demonstration of small scale, transportable plasmid manufacturing capability will allow the industry to consider future paradigms for distributed manufacturing. Such paradigms have not been tested in against current guidelines.
The team will purchase a fully portable GMP plasmid production system that can be placed onto mobile vehicles (trucks) and moved to any reasonable geographic location.
The creation of this testbed will help demonstrate the use of portable GMP manufacturing capabilities in support of the nation's response to mRNA vaccine manufacturing and viral vector manufacturing. In addition, the creation of the testbed is well-aligned with key strategic Manufacturing USA-related Goal 2: Facilitate the transition of innovative technologies into scalable, cost-effective, and high-performing domestic manufacturing capabilities, including the two associated objectives:
The demonstration of this equipment will establish the feasibility of surging production of a key raw material necessary for mRNA vaccine production which can accelerate the national response to pandemics by increasing production of necessary raw material
The transportable plasmid production testbed demonstrates the ability to build and operate a GMP like facility capable of making plasmid DNA and that can be transported to various locations. Such a technology would enable rapid response to manufacturing needs in response to public health emergencies and other applications.
A fully commissioned plasmid production testbed built from a pod-based design.
Processing equipment for E. coli plasmid production at 50L scale
Login to the NIIMBL member portal to access additional project information, including presentations, progress updates, reports, and more.
Not yet a member? Learn more about which level of NIIMBL membership is right for you and your organization.
NIIMBL
IPS-Integrated Project Services, LLC
