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CordenPharma & Wacker Prepare for mRNA Vaccine Production

Edition 2 / June 2022
News > CordenPharma & Wacker Awarded Pandemic Preparedness Contract

Edition 2 / June 2022

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Jens Hartmann
Associate Director of Corporate Development,
CordenPharma International, headshot

Author
Jens Hartmann,

Associate Director of Corporate Development
CordenPharma International


Close up of girl smiling at Pediatrician holding oral solid dose pills in their hand

CordenPharma & Wacker Awarded Pandemic Preparedness Contract

Sterile injectable with vial of a COVID-19 mRNA vaccine with CordenPharma’s lipid platform graphic.

CordenPharma and Wacker are honored to be among the companies awarded a stand-by production agreement with the German government to produce mRNA vaccines when needed.

After several months of a tendering process, a bidding consortium consisting of CordenPharma and our partner Wacker was honored in April 2022 with the award of a stand-by production agreement with the German government to produce mRNA vaccines for Germany, if the COVID-19 pandemic continues or a new pandemic occurs. We are very proud to have been selected as one out of five long-term partners to begin preparing for potential vaccine supply, if needed. Following a two-year preparation phase, both companies will be jointly ready to produce the entire mRNA vaccine manufacturing supply chain over the five-year contracted period.

In December 2021, CordenPharma was pleased to announce the beginning of our joint R&D collaboration agreement with Wacker in the area of Lipid NanoParticles (LNP) formulation. Their complementary capabilities and expertise in the plasmid DNA and mRNA space perfectly coincided with CordenPharma’s expansion of critical lipid excipient manufacturing for mRNA vaccines and increased capacity for LNP Formulation and injectable fill & finish, leading to this logical next step in our strong collaboration. The stand-by production agreement awarded from the German government is expected to be rolled out in various sites between CordenPharma and Wacker as highlighted below.

Over the past months, CordenPharma and Wacker developed a thorough pandemic preparedness plan in which they jointly designed their strategy towards further enhancing existing capabilities and developing sites to produce mRNA vaccine supply from end-to-end when needed. The moment the German government activates the contract, CordenPharma and Wacker will begin manufacturing the requested number of vaccine doses (up to 80 million per year).

While Wacker focuses on producing plasmid DNA (pDNA) and mRNA, CordenPharma will provide expertise and an unprecedented track record in producing custom and standard lipids and in sterile injectable fill & finish.

The below overview summarizes the various sites and capabilities included in jointly covering the entire mRNA vaccine production chain:

  • >> Wacker Biotech in Halle, Germany – After expanding the Halle site into an mRNA competence center, it includes the manufacturing of pDNA, mRNA actives based on such pDNA, as well as LNP formulation.
  • >> CordenPharma in Frankfurt-Fechenheim, Germany – Manufacturing and purification of custom lipids (cationic & PEG lipids). An expansion project in the area of peptides and lipids, as well as an upgrade to GMP capabilities, is currently taking place at this location.
  • >> CordenPharma in Chenôve, France – Manufacturing of standard lipids (including BotaniChol® – CordenPharma’s plant-based cholesterol solution – and phospholipids) based on existing capacities at the site.
  • >> CordenPharma in Caponago, Italy – Aseptic fill & finish of the mRNA vaccine formulated by Wacker in Halle, as well as the secondary packaging of the final vaccine. An investment program for the low temperature handling and storage typically required by mRNA vaccines has been kicked off. Furthermore, the site is also capable of LNP formulation (acting as a back-up site for the consortium).

The consortium of CordenPharma and Wacker is very pleased that their joint expertise covering mRNA vaccines will contribute towards ongoing supply security in Germany, and may help in the fight against any future pandemics.

CordenPharma looks forward to also providing our new and existing customers with extended services and manufacturing capabilities around mRNA vaccines. The services range from the supply of a full set of lipids required for LNP formulation produced in our EU or US-based facilities, to LNP formulation development, including Aseptic fill & finish of vaccines at our Italian site CordenPharma Caponago.


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