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New capability will support manufacturing of commercial-stage therapies to help combat cancers and genetic diseases.
Aldevron, a manufacturer of plasmid DNA, mRNA, and proteins that serves clients in the biotech and pharma industries, will expand its mRNA production capabilities to include lipid nanoparticle (LNP) encapsulation and aseptic fill-finish capabilities, enabling mRNA current good manufacturing practice (cGMP) manufacturing services from master cell bank through to drug product. This new capability will support the production of therapeutic-scale clinical and commercial-stage mRNA therapies for cancers and genetic diseases, along with clinical-stage vaccines for infectious diseases.
In this endeavor, Aldevron—who was acquired by Danaher Corporation back in June 2021—is partnering with other Danaher operating companies, Precision Nanosystems (PNI) and Cytiva. When fully operational in the second half of this year, the services plan to leverage PNI’s lipid nanoparticle portfolio (LNP) formulation experience, while also using Cytiva’s SA25 aseptic filling workcell.
“ … Our goal is to compress the timeframes needed in therapy development and commercialization to accelerate the delivery of innovative mRNA therapies to patients,” notes Mark Wetzel, Aldevron’s VP/GM of mRNA services. “Leveraging the collective strength that includes Cytiva, Precision Nanosystems and valued external partners, Aldevron will provide a complete solution for mRNA development within a single workflow and quality system.”