Analytical testing is a critical factor in the development of mRNA-based therapeutics, while at the same time presenting significant challenges. Pre-clinical and clinical testing are only part of what needs to be included in the development process, with the need to meet regulatory requirements while competing in the marketplace being additional considerations.
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.
Commonly, when a person hears about Escherichia coli (E. coli), the news is negative. But it’s only a specific strain of E. coli detected on food that wasn’t cleaned or stored properly that’s a health hazard. When it comes to biotech, however, E. coli rocks! It’s been the workhorse for the creation of a multitude of products due to:
