2020 was devastating. It was also a year of firsts. Fueled by decades of research and widespread global cooperation, the first mRNA-based vaccines against SARS-CoV-2 were produced, tested, and injected mere months after COVID-19 hit. Science spoke, telling us these vaccines—the first mRNA drug products—were effective at protecting against this prolific killer. Production processes were put into action at lightning speed, but these were far from optimized.
With mRNA technology proven, the floodgates are now open to a deluge of possibilities. Can we use mRNA to make vaccines to other infectious agents? To treat cardiovascular disease or cystic fibrosis? To target one person’s unique cancer? Countless firsts are on the horizon. But to realize the sheer volume and breadth of mRNA uses being considered, we as an industry need to do what we’ve done with mAbs to bring yields and efficiencies up and costs down. And we must continue to adapt to the trends for a greater number of biologics at smaller scales, produced locally.
That means developing platform processes for all steps, from making the DNA template and mRNA molecules through purifying, encapsulating, filling, and testing. And ensuring that these processes are scalable to dose one patient or millions. And finally, baking in the flexibility to manufacture anywhere in the world and to adopt innovations waiting in the wings to shave time, labor, and cost. Modular manufacturing solutions based on single-use technology – with operations integrated and automated across the workflow – were one answer for mAbs. And they offer the same promise for mRNA.
We’ll learn quickly from our collective experience with other biologics. And we’ve got some of the brightest and most industrious on the case to solve the challenges unique to mRNA. Read this collection of articles to join the mRNA evolution and bring more ‘firsts’ to patients.