At the end of 2018, BPI published its first eBook about mRNA drug products — and quite a lot has happened since then! Our initial report highlighted companies working on mRNA therapeutics for cystic fibrosis, heart disease, and cancer, as well as vaccines. The latter approach took off in 2020 with the advent of SARS-CoV-2 and the COVID-19 pandemic, and in a stunningly short time, the biopharmaceutical industry has learned much about manufacture, formulation, product design, and distribution of mRNA drug products. Reflecting on that 2018 publication, this eBook takes stock of recent advances in mRNA production and identifies continuing areas of need.

First, BPI’s editor in chief and former editorial assistant explore mRNA’s potential applications, not only for vaccines, but also for cancer treatments and beyond. Next, BPI’s senior technical editor speaks with an industry consultant about technical factors that have propelled mRNA into the limelight, including improvements in lipid nanoparticle (LNP) systems. Their conversation also sheds light on unprecedented demand for mRNA-related reagents and raw materials as well as continuing challenges with developing mRNA drug product formulations that do not require ultracold storage. Finally, a leader from DPS Group Global calls attention to challenges that arise when designing facilities for manufacture of mRNA drug products, which straddle the requirements for conventional biopharmaceuticals and small-molecule drugs.

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