Manufacturing and processing challenges surrounding mRNA can be overcome in order to realize the true potential of a technology 30 years in the making.
Medicines have existed since the beginning of time—from what nature provided to the evolution of modern science. There has been a rapid evolution of APIs over the years, driven by innovation with different therapeutic modalities, which, due to varying challenges, require manufacturers to continuously learn and optimize their design processes. From antibodies to viral vectors to messenger RNA (mRNA) to oligos, each modality comes with its own ecosystem for manufacturing that requires the flexibility to grow quickly.
It's not just about the molecule mRNA. It’s the right molecule at the right time. Thanks to the rapid development of mRNA vaccines for COVID-19, the industry now has the momentum to overcome the challenges to realize the enormous potential of this technology.
Long before COVID-19, a small group of dedicated scientists and researchers had been studying and advancing this technology for cancer and other diseases. It took more than 30 years to overcome obstacles, such as mRNA destruction by chemicals in the blood. Fortunately, for the pandemic, scientists figured out how to teach the immune system cells to consume mRNA without drastic immune reactions.
Now, innovation is accelerating the development of these therapeutics. With proven potential, the industry will see the creation of new molecules that will hopefully lead to improved treatments for patients. With these advancements come process challenges and the need to build resilient and flexible manufacturing strategies that can adapt to the changing needs in a nascent industry.
Scott Ripley is the general manager, nucleic acid, for Cytiva.
BioPharm International
eBook: Emerging Therapies 2022
September 2022
Pages: 4–8
When referring to this article, please cite it as S. Ripley, " Accelerating the Development of mRNA Therapeutics," BioPharm International’s Emerging Therapies 2022 eBook (September 2022).