Messenger RNA (mRNA) based drugs and vaccines make up a new class of medicine showing tremendous promise. Compared to established drug and vaccine technologies, mRNA has the potential to reach patients faster by being easier to develop and produce.
Similar to a comedian developing a stand-up routine around the latest trends, a Chief Scientific Officer (CSO) drives current methods and technologies for biological therapeutics. Both have insightful viewpoints of their trade, with the CSO closely working in the world of both academic and industrial research for development of drug products from conception to commercialization.
Guten tag from Berlin! As an analytically minded-person, it’s fascinating to connect with colleagues from around the world to discuss cutting-edge techniques and strategies for ensuring the quality, efficacy, and safety of mRNA-based therapeutics. That fascination led me to the mRNA Analytical Development Summit, held in Germany's capital city.
The manufacture and release of mRNA therapeutics and vaccines is a complex and challenging process requiring a high degree of expertise, capabilities, and experience. The development and manufacturing of final drug product involves several stages that include production of cell banks, linear DNA, and mRNA drug substance, with lipid nanoparticle (LNP) formulation/encapsulation and analytical testing at all steps, through aseptic fill/finish.
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.
The manufacture and release of mRNA therapeutics and vaccines is a complex and challenging process that requires a high degree of expertise, capabilities, and experience. The production process involves several stages, including the production of cell banks, linear DNA, mRNA drug substance, LNP encapsulation, fill/finish, and analytical testing at each step. Each production stage must be executed with extreme care to ensure the final product's safety and efficacy.
In the past, the TIDES USA conference event has been focused on oligonucleotide and peptide therapeutics, providing information on development trends and technologies for those industry segments. That is changing now, with an additional focus on mRNA therapeutics coming into the mix.
After years of service providers becoming more specialized, we’re now seeing a reversal in that trend. Enterprise offerings and solutions are on the rise, from consumer offerings to huge corporate deals. We can attribute this growth to an increased demand for simplicity of transactions, clear accountability, and building a win-win situation for both parties.
