Making the Promise of mRNA a Reality: Overcoming Scale-Up Challenges


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Making the Promise of mRNA a Reality: Overcoming Scale-Up Challenges eBook coverIf scaling issues strike you as obvious or even boring, you should read “On Being the Right Size,” a 1926 essay by geneticist J.B.S. Haldane. It makes the case that a difference in scale—a seemingly simple matter—may demand subtle changes in form and function. For example, it explains why a flea’s jumping abilities, in proportion to its body size, are so much more impressive than those of an elephant.

Now, if differences in scale are tricky, changes in scale are even trickier. Scaling up a production process, for example, can be a journey of discovery—a journey in which simply multiplying process inputs and equipment dimensions can lead to a dead end.

Scale-up journeys sound daunting—especially if they need to cover a lot of ground quickly. That’s certainly the case with the manufacture of mRNA products. With the sudden success of the mRNA-based COVID-19 vaccines, developers are eager to commercialize mRNA products of all kinds. Besides vaccines that ward off viral diseases, mRNA products include cancer vaccines, new forms of gene therapy, and biologics to treat chronic disease.
Such developers may consider this eBook their guide. It shows how to approach the daunting landscape of scaling up in vitro transcription. For example, it describes the materials, equipment, workflows, process conditions, and quality control measures that impact mRNA production. It also explains that changing any of these elements may involve lengthy detours—and present opportunities to bypass obstacles.

This eBook also emphasizes that the mRNA journey is actually an expedition—an undertaking that demands teamwork. The scale-up of mRNA production occurs more reliably and efficiently if developers have good relationships with suppliers and technical specialists.

Also, like every expedition, mRNA expeditions have their visionaries. In this eBook, visionaries include experts from Thermo Fisher Scientific, MIT’s Robert Langer, advocates of “smart” manufacturing, and scientists who are developing ways to automate the analysis of post-transcriptional modifications.


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