By Sebastian Almeida, Director, CMC, Akron Biotech; Lloyd Jeffs, Director, Clinical Manufacturing Solutions, Precision Nanosystems; John Harmer, Head of Marketing, Aseptic Filling, and Katarina Stenklo, Enterprise Solutions Activation Leader, Cytiva
The rapid development of innovative vaccines allowed for the pharmaceutical industry to deliver its first tools in the fight against the COVID-19 pandemic. The Moderna and Pfizer BioNTech vaccines, which offer 94% efficacy for fully vaccinated adults, both rely on messenger RNA (mRNA).
Even prior to the rise of COVID, with clinical testing of some mRNA vaccines, the ability to “program” mRNA with genetic code to treat/prevent disease has been known for decades. However, the challenges associated with transitioning mRNA into a drug product have hindered its potential.
Now, the success of the mRNA vaccine market is fueling high demand for mRNA, resulting in a critical need to address mRNA manufacturing bottlenecks. As manufacturers across the industry continue to pursue mRNA-based therapies, it is important they understand the challenges they may face in their journey and which solutions could help overcome them.