Innovative Continuous mRNA Manufacturing Platform to Enhance Vaccine Development

A groundbreaking three-year research initiative, spearheaded by faculty at a leading university, aims to create the world’s first fully integrated continuous mRNA manufacturing platform. This $82 million project is funded by the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research, and is set to enhance society’s ability to respond to future pandemics while expediting the development of mRNA technologies.

Innovating mRNA Manufacturing for Future Health Challenges

Companies are making unprecedented investments in these technologies, seeking to create new vaccines and treatments for cancers, metabolic disorders, genetic diseases, and more.

According to Richard Braatz, a distinguished professor in the Department of Chemical Engineering, “These companies are investing hundreds of millions into mRNA not solely because of Covid, but due to its promising potential across various disease areas. By reducing the cost and time for development, we can unlock a multitude of new applications.”

Collaboration Driving Engineering Breakthroughs

This ambitious project will address complex engineering challenges with collaboration from researchers at another esteemed university and a renowned polytechnic institute. A significant portion of the project is subcontracted to a specialized firm focused on implementing the innovative end-to-end process in a pilot-scale manufacturing facility.

The core objective of this initiative is to propel the field of mRNA therapeutics forward by establishing a continuous manufacturing framework that companies can adopt. This effort also aims to foster collaboration within the biopharmaceutical industry.

The research team will closely engage with the FDA to ensure that the pilot-scale system complies with current good manufacturing practices and supports regulatory strategies, thereby substantially mitigating risks associated with mRNA technology development.

Public Health Impact and Regulatory Support

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, emphasizes the public health implications of this project, stating that a continuous mRNA manufacturing platform could serve as a flexible, responsive tool for addressing emerging health threats globally.

“We need to prepare for the next pandemic instead of reacting to the last one. The goal is to develop vaccines immediately after identifying a virus. Current technologies are too slow; however, advancing these processes could change that.” – Richard Braatz

Advancements in Continuous Manufacturing Technology

Messenger RNA (mRNA) carries essential instructions that cells require to produce proteins. While scientists have explored mRNA for decades, its application in developing effective Covid-19 vaccines has accelerated advancements in this technology.

Traditional mRNA production involves batch processes with multiple steps that can lead to production bottlenecks. In contrast, continuous manufacturing enables uninterrupted production, eliminating delays associated with batch transitions.

Researchers affirm that integrated continuous manufacturing processes can significantly shorten drug development timelines, ensure a modular supply chain, and reduce costs. Furthermore, such manufacturing methods are expected to enhance mRNA quality through automation and real-time analytics.

Future Prospects and Industry Transformation

These advancements are crucial in meeting the surging demand for mRNA materials and enabling rapid scaling of new mRNA vaccine production during public health crises.

Funding from the FDA will be allocated to the university over three years, with substantial collaboration already underway on automation and advanced quality assurance controls.

Paula T. Hammond, an esteemed professor and head of the Department of Chemical Engineering, highlights, “Continuous manufacturing of mRNA therapeutics holds immense potential. The capability to swiftly and safely produce targeted mRNA treatments for known and emerging threats is invaluable.”

This new research program builds upon previous successes from a notable collaboration that developed the world’s first bench-scale integrated continuous manufacturing system.

Allan Myerson, a practicing professor at the university, adds that while continuous production is standard in large-scale chemical manufacturing, pharmaceuticals have traditionally relied on batch processes. However, there has been a significant shift towards continuous methods in recent years, and the FDA has been supportive of these advancements due to their efficiency and potential for consistently high-quality products.