Lowering the Cost-of-Goods for Making mRNA-Based Vaccines Utilizing Continuous mRNA Manufacturing

This project advances CAMERNA, a continuous mRNA manufacturing system that reduces cost-of-goods by minimizing reagent use, automating production, and enabling scalable, low-cost vaccine manufacturing for global health access.
Categories
Drug product

Industry Need

There is no currently available Continuous process for end-to-end mRNA synthesis for vaccines.

Approach

The proposed solution leverages CAMERNA, a novel continuous automated manufacturing system, to enable end-to-end production of mRNA drug substance. This continuous, modular approach eliminates the need for DNase, reduces reagent usage, and supports scalable, low-cost, on-demand mRNA vaccine manufacturing.

Impacts

Accelerated mRNA Vaccine Development

Reduction in Cost-of-Goods

Value Statement/Outcomes

By implementing the CAMERNA continuous mRNA manufacturing system, an organization could reduce cost-of-goods by up to 1000-fold through decreased reagent usage, elimination of DNase and plasmid DNA requirements, and conservation of single-stranded DNA templates, enabling highly automated, scalable, and cost-effective mRNA production with minimal labor and facility footprint.

Outputs/Deliverables

Optimized Affinity Resin

In virto Transcription (IVT) optimization

Integration of sensor and control system

Continuous test run

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Project Lead

Sepragen Corporation

Sepragen Corporation

Participating Organizations

University of Massachusetts Lowell

University of Massachusetts Lowell