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 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.
Demand for mRNA continues to rise and earlier this Spring, we announced the expansion of our mRNA custom manufacturing— going from a cell bank to a drug product — to help meet demand. Doing that required combining our capabilities with the technologies and expertise of two other Danaher companies, Cytiva and Precision NanoSystems Inc. (PNI). Genetic Engineering News covered the story, interviewing Todd Howren/ PhD, Aldevron's VP of RNA.