In my previous post regarding the differences between capacity and capability, I discussed the point that reasonably successful CDMOs have the capacity to manufacture biomolecules in a reproduceable manner and deliver according to a timeline. However, sometimes clients tend to focus on a near-term timeline when evaluating potential CDMO partners, relegating matters that dictate long-term clinical success to future consideration.
Overnight success is often the result of years of effort and setbacks, which could be the life story of an mRNA pioneer, Dr. Katalin Karikó, now with the Perelman School of Medicine at the University of Pennsylvania. Karikó spent decades focusing her research on how mRNA could be used for therapies, which ultimately helped lead to the development of COVID-19 vaccines.
Capacity: The total amount that can be contained or produced
Capability: The ability to do something
*As defined by the Cambridge Dictionary
One of the issues I’ve heard raised in our industry is about how we define capacity and capability. As you can see from the definitions above, these are two very different items. But what do these two terms mean with respect to the manufacture of mRNA drug substance and/or drug product?
While research into RNA, including mRNA and related derivatives, has been ongoing for almost 50 years, it’s taken the COVID-19 pandemic to accelerate the development of vaccines using this technology. mRNA provides an incredible opportunity to develop new treatments for viral based, genetically driven, or cancerous diseases.
During conferences and seminars this year, there has been one particular topic that has come to the fore regarding mRNA production – capacity. Most of the concern comes from the impression that there isn’t enough capacity to meet market demand.
