Aldevron will offer mRNA cGMP Production from Master Cell Bank to Drug Product Made Possible with Precision Nanosystems and Cytiva
- - The collaboration aims to support Aldevron clients with the ability to seamlessly manage clinical and commercial mRNA programs.
- - When fully operational, the services will leverage Precision NanoSystem’s LNP formulation expertise, and feature Cytiva’s SA25 aseptic filling workcell. The goal is to streamline, expedite, and simplify mRNA programs for clients by reducing lead times within a single workflow and quality system.
- - Access to one manufacturing solution by utilizing a single CDMO partner for pharmaceutical-grade RNA-LNP drug product for clients and partners under a single ecosystem, minimizing the logistical complexity of multiple vendors that leads to major risks for RNA program success.
Fargo, North Dakota and Vancouver, British Columbia/PR/Newswire/May 1, 2023 -- Aldevron, a leading global manufacturer of DNA, RNA and proteins used in cell and gene therapies and vaccine development, will expand 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. This 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 Corporation (NYSE:DHR) 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.”
The expansion is anticipated to be fully online in the second half of 2023.
Aldevron is a premier manufacturing partner, producing high-quality plasmid DNA, RNA, proteins, enzymes, and other key components for the development of vaccines, gene and cell therapies, immunotherapies, and other treatments. Headquartered in Fargo, North Dakota, and as a part of the Danaher Corporation (NYSE: DHR) family of global science and technology companies, Aldevron supports thousands of scientists who are developing revolutionary, lifesaving treatments for millions of people. To learn more about how Aldevron is advancing biological science, To learn more, visit Aldevron's mRNA services page.
About Precision NanoSystems
Precision NanoSystems (PNI) is a global leader in technologies, solutions, and services for the development of lipid nanoparticle delivered genomic medicines, including mRNA vaccines and therapeutics. We support (bio)pharma companies who are ushering in the next wave of genomic medicines in infectious diseases, cancer, and rare diseases. We work with the world’s leading drug developers to understand disease and help create the therapeutics and vaccines that will define the future of medicine. Our mission is to accelerate the creation of transformative medicine that significantly impacts human wellbeing, visit www.precisionnanosystems.com/.
Danaher is a global science and technology innovator committed to helping its customers solve complex challenges and improving quality of life around the world. Its family of world class brands has leadership positions in the demanding and attractive health care, environmental and applied end-markets. With more than 20 operating companies, Danaher’s globally diverse team of approximately 81,000 associates is united by a common culture and operating system, the Danaher Business System, and its Shared Purpose, Helping Realize Life’s Potential. For more information, please visit www.danaher.com.