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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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To overcome the challenges and bottlenecks associated with pDNA, a proprietary polymerase chain reaction (PCR) solution has been developed to combine the high quality benefits of synthetic templates with accuracy and scalability. Continue reading to learn more about this solution that assigns the high accuracy of PCR to mRNA manufacturing.
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Lipid nanoparticle (LNP) formulation is a cornerstone of modern drug delivery, especially for RNA-based therapeutics. Gain insight into the science behind LNP formulation development, from ionizable lipids to scalable manufacturing through case studies, screening strategies, and flexible approaches for advancing next-generation therapeutics.
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Manufacturing mRNA-LNP and other complex drug products demands precision, sterility, and efficiency, especially when working with high-value APIs and small batch sizes. Explore how a modular fill-finish platform streamlines operations without compromising quality.
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mRNA & LNP CTDMO Services
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Bringing mRNA & LNP to life takes more than experience; it takes passion. We’re all in to simplify the journey of advancing your therapies to patients. Discover GMP-ready, fully connected services — from DNA to lipid manufacturing, LNP formulation and manufacturing, and Fill & Finish. Choose from end-to-end or standalone offerings — tailored to your path and your pace. We stay focused on helping you move forward, every step of the way. Together, we’re all in.
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