Centillion Technology Ltd. has secured substantial and prestigious funding from the RNA Readiness and Response programme of Wellcome Leap Inc and CEPI, to develop new manufacturing technologies for production of RNA based drug products including mRNA vaccines.
Centillion will be working with Quotient Sciences, a drug development and manufacturing accelerator, alongside a global consortium, led by King’s College London. The consortium includes universities and industry, including Imperial College London, The Centre for Process Innovation, the University of Nottingham, Strathclyde University, AqDot Ltd, amongst others. The project is to design and construct the Biofoundry-in-a-box (BiaB), a modular, flexible, and automated micro-factory for rapid and on-demand manufacture of RNA-based drug products. BiaB will be a revolution in the rate of development and production of RNA-based therapeutics, providing benefits of multi-product manufacture and short lead times. Centillion’s role is built on its know-how and technology platforms on continuous manufacturing and lead the engineering and construction of the BiaB and its deployment in the GMP facilities of Quotient.
RNA therapies are transforming the outlook for human health, the accelerated development of mRNA vaccines for SARS-CoV-2 is a testament to that. There remains a significant challenge of how to increase exponentially and equitably the availability of such products and how to ensure there is sufficient manufacturing capacity to respond rapidly to future pandemic needs.
How it works
The BiaB will integrate modular RNA substance synthesis and formulation in a continuous Quality by Design (QbD) manufacturing stream, supported by intelligent computer control via its Digital Twin. A BiaB will be used primarily for cell-free routes for RNA product manufacture. Disease-specific RNA sequences (drug substance) produced with a BiaB, will be formulated on-demand by selecting the correct preparation route and excipients from a library of options. By flexibly configuring formulation with a BiaB, target clinical needs in terms of delivery, system administration method, concentration, and overall product quantity can be rapidly met. The final output of the BiaB will be the RNA drug product in the form of a sterile bulk bag ready for final ‘fill-finish’.
Commenting on the project, Prof. Chris Frampton, Chief Scientific Officer, said: “The concept and vision of the Biofoundry-in-a-box is the result of research into continuous RNA vaccine manufacture performed over the past four years by Centillion Technology and its partners. The Biofoundry is a transformative step in the manufacture of new medicines and therapies for human health. Martin Elliott, Chief Commercial Officer added: “Successful execution of this programme will lead to the clinical needs of a significantly greater number of people being achieved faster and more effectively.”
