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
Active Immunization Countermeasures

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. 

Approach

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. 

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

Value Statement/Outcomes

The portable GMP plasmid production testbed enables rapid, relocatable manufacturing of a critical raw material for mRNA vaccines and gene therapies, reducing lead times from months to weeks and avoiding millions in outsourcing costs. It also delivers strategic benefits in pandemic preparedness, workforce training, and technology transfer.

Outputs/Deliverables

Fully commissioned portable GMP plasmid production testbed using modular G-CON PODs and integrated bioprocessing equipment.

Validated GMP-compliant plasmid production process, including upstream fermentation, downstream purification, and formulation workflows.

Renovated and qualified warehouse facility with necessary utilities and environmental controls to support POD installation.

Documented SOPs, batch records, and best practices for mobile GMP plasmid manufacturing and technology transfer.

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Project Lead

NIIMBL

NIIMBL

Participating Organizations

IPS-Integrated Project Services, LLC

IPS-Integrated Project Services, LLC