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Over the past few years, there has been rapid progression and commercialization of mRNA vaccines and therapeutics, in large part due to the emergence of COVID-19. The lipid nanoparticle (LNP) technology underpinning this new drug modality enabled biopharmaceutical companies to adapt existing knowledge and processes developed for other applications to create vaccines within an accelerated timeline. However, navigating the regulatory and manufacturing landscape surrounding these developments has not been without its challenges.

In this new Special Report, gain insights into opportunities, challenges, and strategies for success, including:

  • How standardizing CMC, proactive engagement with regulators, and unified global standards can streamline approvals

  • Scale-up strategies, comprehensive analytics, and facility considerations for GMP manufacturing

  • How to increase operational flexibility and expand LNP delivery to new applications such as personalized medicine.

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