RNA manufacturing platforms

Challenge and opportunities

RNA vaccines offer many advantages, in particular, the ability to design a general-purpose rapid response manufacturing platform. The platform itself is agnostic to the genetic code and thus widely applicable to different products and settings.

For this particular application, we have chosen self-amplifying RNA (saRNA), effective at up to 1000-times lower doses than modified mRNA, therefore more cost-effectively scalable for human vaccination.

Their fully synthetic nature and ease of production are in the spirit of distributed, localised manufacturing systems to meet the challenges of any emerging pathogen within a relatively short time.

Methodology

We will establish a modular GMP platform for synthetic RNA vaccines at NHS Blood & Transplant – Clinical Biotechnology Centre (NHS BT - CBC), taking advice from collaborators at Nottingham U., Imperial College, CPI, NIBSC, and others.

This will provide a self-sustaining blueprint for distributed manufacture that could easily be replicated across other LMIC centres.

We shall work on vaccines such as Rabies and Chikungunya, building on the PI’s existing programme exploring saRNA approaches for Ebola, Lassa and Marburg. The key challenge is not proving the cGMP manufacturability, but how to make a modular platform that can be used as a blueprint for distributed manufacture and easily replicated across other LMIC centres.

Key outcomes from this workstream

• Optimised process development for saRNA manufacture 
• Established analytical methods for product release and stability testing 
• Defined pathway for regulatory approval to support clinical testing 
• Blueprint for modular GMP manufacture, including material management, in an LMIC setting
• Development of a rapid response platform for emerging infections