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Given their critical function in drug products, the purity and safety of novel synthetic lipid excipients must be thoroughly demonstrated. Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.
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Navigating clinical trials to bring a molecule to market poses numerous challenges, including meeting the regulatory standards for approving new mRNA-based drugs. Explore the regulatory requirements for mRNA drug substances and products, the importance of phase-appropriate quality, and insights on creating CMC documentation to ensure compliance.
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When it comes to developing and bringing mRNA-based therapeutics to market, you need robust, integrated, and consistent processes at every stage from pre-clinical to commercialization. You can rely on a CDMO partner with 20+ years combined track record in mRNA, Lipids and LNP manufacturing to provide tailored services supporting you in accelerating your projects, managing risks, and expediting time to market.
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