Aldevron, a global manufacturer of DNA, RNA and proteins used in cell and gene therapies and vaccine development, is expanding its mRNA production capabilities to include lipid nanoparticle (LNP) encapsulation and aseptic fill-finish capabilities enabling mRNA cGMP manufacturing services from master cell bank through to drug product. The expansion is expected to be fully online in the second half of 2023.

The new capability will support the production of therapeutic-scale clinical and commercial-stage mRNA therapies for cancers and genetic diseases, and clinical-stage vaccines for infectious diseases.

Aldevron, a Danaher Corp. operating company, is partnering with fellow Danaher operating companies Precision Nanosystems (PNI) and Cytiva. The service expansion will provide Aldevron clients with the ability to seamlessly manage clinical and commercial mRNA programs.

When fully operational, the services will leverage PNI’s LNP formulation expertise, and feature Cytiva’s SA25 aseptic filling workcell. The goal is to streamline, expedite, and simplify mRNA programs by reducing lead times with less project overhead. 

“This collaboration will help to bring innovative and life-saving therapies to patients faster,” said Kevin Ballinger, president of Aldevron. “By working with PNI and Cytiva, Aldevron can capitalize on their expertise to build a streamlined service for the development, production and release of mRNA drug substance and drug product. Combined with our manufacturing expansion completed in March of this year, we can now offer our customers improved flexibility across a range of mRNA services.”

“With Danaher’s best-in-class scientific and technical expertise, our goal is to compress the timeframes needed in therapy development and commercialization to accelerate the delivery of innovative mRNA therapies to patients,” said Mark Wetzel, vice president/general manager 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.”