USA —The Massachusetts Institute of Technology (MIT) has embarked on a groundbreaking venture to design and implement a new continuous mRNA manufacturing platform with financial support from the federal government.
Backed by US$82 million from the FDA’s Center for Biologics Evaluation and Research (CBER) over three years, the project aims to advance the field of mRNA therapeutics by creating a template for continuous manufacturing, promoting collaboration across the biopharma industry.
The development work will be carried out by MIT researchers in collaboration with experts from Penn State University.
Additionally, a portion of the project has been subcontracted to CDMO ReciBioPharm, which will oversee the pilot manufacturing site.
MIT emphasizes that the research team will work closely with the FDA to ensure compliance with good manufacturing practices and regulatory guidelines.
The significance of this project lies in the potential of a continuous mRNA manufacturing platform to effectively address emerging health threats, both domestically and globally.
By providing an adaptable and agile tool, the platform holds promise for public health, as stated by Peter Marks, Director of CBER.
Building upon the success of the Novartis-MIT Center for Continuous Manufacturing, a program that ran from 2007 to 2019 with a budget of US$85 million, this new research program aims to further advance continuous manufacturing capabilities.
The Novartis-MIT program successfully developed and demonstrated the world’s first integrated continuous manufacturing system at the bench scale.
Unlike the current batched production method for mRNA, which often faces bottlenecks and delays, continuous manufacturing enables uninterrupted production without pauses or transfers between batches.
This efficient approach not only meets the surging demand for mRNA materials but also facilitates rapid scale-up of production for new mRNA vaccines during pandemics or other public health emergencies.
While most pharmaceutical products are currently produced in batches, the FDA is actively setting standards and guidelines for continuous manufacturing.
In March of this year, the FDA adopted guidelines for this progressive manufacturing process, underscoring its commitment to advancing and regulating this innovative approach.
Messenger RNA-based products hold immense therapeutic potential, ranging from vaccines to treatments for cancer, infectious diseases, metabolic disorders, and rare conditions.
The rapid development of mRNA-based vaccines against SARS-CoV-2 has fueled scientific and public interest in this technology.
mRNA-based therapeutics involve the use of biologically active mRNA molecules and carriers to ensure stability and efficient delivery within cells.
The mRNA is typically generated through an “in vitro transcription” process that mimics natural transcription in the human body.
The DNA coding for the desired protein is transcribed into mRNA using specific enzymes. The purified mRNA is then encapsulated in lipid nanoparticles (LNPs).
While these steps remain consistent for different mRNA-based products, the DNA sequence encoding the specific protein of interest varies.
The continuous mRNA manufacturing platform being developed by MIT holds great promise for revolutionizing the production of mRNA therapeutics, facilitating more efficient and rapid manufacturing processes to meet evolving healthcare needs.
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