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Portable GMP plasmid production testbed

This project will produce a mobile and modular plasmid production laboratory capable of upstream and downstream active ingredient production.
Categories
Vaccines

Industry Need

  • The coronavirus pandemic has demonstrated the important role that mRNA vaccines can play in the response to global health crises. 
  • While much of the manufacturing of these mRNA vaccines relies on the synthesis of the mRNA molecule from a DNA template and the subsequent creation of the mRNA – lipid nanoparticle complex, the fundamental first step of the manufacturing is based on the creation of a plasmid DNA template. 


Solution

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: 

 

  • Objective 2.1: Enable access by US manufacturers to validated manufacturing capabilities, industrially relevant materials, equipment, and capital intensive infrastructure to encourage growth in the US manufacturing base. 
  • Objective 2.2: Facilitate documentation and nationwide sharing of best practices for addressing advanced manufacturing challenges and implementing solutions. 


Outcomes and Impacts

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

Updates, Related Publications, and Deliverables

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Participating Organizations

IPS-Integrated Project Services, LLC

IPS-Integrated Project Services, LLC

NIIMBL

NIIMBL

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