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Efficient scale-up is the key to efficient commercial formulation

At a recent Lipid Nanoparticle (LNP) formulation and process development summit held in Boston a delegate observed that “utilising mRNA loaded LNPs is probably the most complicated drug product that humans have ever tried to manufacture”. While the COVID pandemic enabled the remarkable proving of mRNA-LNP technology, given its complexity and the need for rapid deployment, it was to be expected that opportunities for improving this technology pathway would remain. A key driver within this modality is the Pandora’s box of opportunities that this biopharmaceutical technique has opened – from a multitude of infectious diseases to somatic and germ line genetic diseases. This dictates the need for second-generation technologies, both in formulation and process development, to address remaining challenges and the needs for improvement. Simply put, what might be acceptable in a pandemic is not likely to remain so beyond it.

‘what might be acceptable in a pandemic is not likely to remain so beyond it’

Denis Smit, Commercial Director, Micropore Technologies

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