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How the FDA’s $82 million grant is accelerating the development and production of mRNA technologies
The COVID-19 pandemic underscored the critical need for uninterrupted access to safe and efficacious pharmaceutical products. The U.S. Food and Drug Administration (FDA) has emphasised the role of a maximally efficient, agile, flexible pharmaceutical manufacturing sector to reliably and consistently produce high-quality biologics.
The Centre for Biologics Evaluation and Research (CBER) within the FDA regulates biological products for human use under applicable federal laws. As such, it promotes the FDA’s vision of ensuring a continuous supply of high-quality therapeutics. CBER has awarded several grants and contracts to drive innovation and encourage the development and adoption of advanced technologies to revolutionise biopharmaceutical manufacturing.
In 2023, CBER provided $82 million to fund a three-year research program aiming to design the world’s first fully integrated, continuous mRNA manufacturing platform. This is one of the largest awards from the FDA’s CBER office to date. Working with the Massachusetts Institute of Technology (MIT), ReciBioPharm is taking on the challenge of making this continuous mRNA manufacturing platform a reality.
A new centre for continuous mRNA manufacturing
Continuous manufacturing — where product manufacturing flow is uninterrupted throughout upstream or downstream processing, or both — has become a key topic within the biopharma industry. This process provides benefits such as the potential to reduce process inefficiencies, minimise staff and equipment requirements, and improve cost-efficiency. As a result, it is no surprise that the biopharma industry is increasingly adopting continuous manufacturing over the alternative batch option. However, this adoption has been slow, in part due to regulatory uncertainty, complexity in scale-up and a lack of standardisation.
The three-year continuous manufacturing research program funded by the FDA will provide a continuous manufacturing template for others in the industry to follow. With this guide, the biopharma industry could improve society’s ability to respond to future pandemics while accelerating the development and production of new mRNA technologies. As revolutionary mRNA therapies enter the development pipeline to tackle a range of indications, including rare diseases, infectious viruses and various cancers, the role of continuous manufacturing in delivering new therapies to patients will grow rapidly.
Drawing on its expertise and experience in mRNA development and manufacturing, ReciBioPham will implement a pilot manufacturing site for the project, ensuring practical implementation of the platform. At the same time, the CBER grant will support MIT researchers and collaborators from Penn State University in tackling project engineering complexities.
Supporting the next great step in mRNA manufacturing
Leveraging continuous and integrated processing, inline process analytics technology (PAT) and centralised control, ReciBioPharm has developed its continuous mRNA manufacturing platform, CP1. By harnessing technological innovations, CP1 elevates operational effectiveness, accelerates mRNA drug product production and increases product purity and yield.
The platform is set to advance rapidly through focused process development, process analytics and artificial intelligence (AI) to deliver therapies to patients quickly through three key pillars:
- Rapid process development
The platform reduces process development (PD) times by up to 90% through the development of a digital twin for process optimisation and leveraging next-generation technologies to establish predictive models.
- Continuous and integrated process
Preventing interruptions through inline process analytics and real-time quality control (QC), the platform increases manufacturing speed by 85%.
- Centralised process control
The platform moves away from unit operation control to single-point operation, embracing hands-off automation and ensuring adaptability to future-generation instrumentation.
An exciting future for mRNA technologies
The three-year continuous manufacturing program funded by the FDA demonstrates the unbridled potential of partnerships between academia, regulatory agencies and development and manufacturing organisations to drive innovation and advance therapeutic fields. By working together with MIT, ReciBioPharm is addressing significant needs in making the medicines of the future.
Interested in discovering more about how ReciBioPharm’s continuous manufacturing offering could support your next mRNA project?
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