Featuring Nate Spangler, Ph.D., Senior Director of Innovation and Strategy. Although messenger RNA has been studied for decades, its promise to be a transformative technology changing the future of medicine wasn’t realized until the recent success of the Covid vaccines.
The rapid transition from promise to reality created unprecedented demand for manufacturing in an industry unprepared. It has also intensified efforts to advance mRNA pipelines, further adding to pressures. Many of the challenge we deal with stem from the newness of mRNA in manufacturing for clinical use.
Compared to better known technologies such as monoclonal antibodies, there is little GMP manufacturing experience, and few mRNA-specific tools and technologies for scale up, which makes it hard for manufactures to stay ahead of rapidly evolving needs.