CordenPharma – WACKER Partnership
Partnership for the Manufacture of Lipids, pDNA / xRNA, LNP Manufacturing & Injectables
CordenPharma and WACKER have formed a strategic partnership to create a unique, fully-integrated service covering the complete supply chain from early clinical to commercial stage development and manufacturing of xRNA-based vaccines and gene therapies, including final injectable fill and finish. Drawing upon the combined market leading strength of both companies, customers benefit from expert teams with vast experience in the xRNA space, cutting-edge technology, and state-of-the-art manufacturing facilities to gain agile, highly-flexible and efficient support to bring their xRNA projects to market.
CordenPharma brings multiple areas of expertise to the partnership, including decades of specialized know-how in the design, synthesis, and manufacturing of a wide range of custom and standard Lipids, and clinical to commercial LNP manufacturing. Our 900m2, Grade C, state-of-the-art LNP facility at CordenPharma Caponago, Italy, offers dedicated capacities for LNP formulation screening, process, analytical, and purification development, alongside GMP LNP manufacturing. Additionally, fully-integrated early clinical to commercial stage aseptic fill and finish injectable drug product production lines are available under one roof, with secondary packaging, serialization and aggregation.
With the opening of their mRNA Competence Center in Halle an der Saale, Germany, Wacker focuses on the manufacturing of plasmid DNA (pDNA), mRNA and Lipid NanoParticle (LNP) formulation and manufacturing services.
pDNA, mRNA and LNP Manufacturing Services
Consortium Formed for Pandemic Readiness
In 2022, as a consequence of the initial vaccine shortages in the coronavirus pandemic, the German government started securing vaccine production and supplies for future pandemics. Pharmaceutical producers with appropriate vaccine expertise and capacity were invited to apply for stand-by production agreements with the German government. As joint bidders with a strategic partnership in place, WACKER and CordenPharma applied for the stand-by production of vaccines based on messenger ribonucleic acid (mRNA).
After only 2 years following the initial award of the contract by the German Government, both companies in the consortium successfully completed the construction of new facilities, expanded existing facilities and finalized the qualification phase. On 1 June 2024, the consortium formed between WACKER & CordenPharma officially entered the pandemic readiness state to produce 80 million vaccine doses within a short time, if needed, for at least five years.
Should the need arise, the German government will contact the developer of the specific mRNA vaccine required and WACKER and CordenPharma will then jointly produce this mRNA vaccine in line with the highest pharmaceutical quality standards.
[Photo by WACKER] Alexander Radspieler, Global Project Manager of CordenPharma and Andreas Anton, Senior Project Leader Pandemic Preparedness of WACKER collaborate as part of the WACKER-CordenPharma consortium for German pandemic preparedness at Wacker’s mRNA Competence Center in Halle an der Saale, Germany.
AI Machine-Learning Algorithm for R&D Formulation of RNA Actives
On 30 March, 2023, Munich’s Ludwig Maximilian University (LMU) and Humboldt University of Berlin (HU Berlin), together with Wacker Chemie AG and CordenPharma International GmbH, launched a project to accelerate the development of RNA-based drugs. The aim was to develop a new generation of lipid nanoparticles (LNPs), which are a key component of RNA-based pharmaceuticals.
Based on these formulations, a machine learning algorithm is being trained that automatically identifies the best constituents for new RNA formulations – as yet a particularly time-consuming and costly development stage. The three-year project started on April 1, 2023 and is receiving funding of some €1.4 million from the German Federal Ministry for Economic Affairs and Energy.
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Contact us to find out more about information on CordenPharma and WACKER’s combined capabilities for the manufacturing of Lipids, Nucleic acids, LNPs, and Injectable Drug Products.