Pandemic Preparedness: WACKER and CordenPharma Will Produce mRNA Vaccines for Germany When Needed

According to the two companies, their bid has now been accepted, along with those of four other companies. WACKER and CordenPharma are expected to manufacture 80 million vaccine doses per year if the Covid-19 pandemic continues or a new pandemic occurs. Additionally, the German government has the option to increase the amount to 100 million doses per year. The two companies will receive an annual stand-by fee for keeping production capacity available. The stand-by phase starts in 2024, once the companies have created the necessary capacity, and ends in 2029.

“We are happy that our expertise in making mRNA vaccines will contribute to the fight against future pandemics. Together with CordenPharma, our partner, we will produce vaccines for Germany should the need arise,” said WACKER’s CEO, Christian Hartel. “WACKER and CordenPharma jointly cover the entire manufacturing chain for mRNA vaccines, which we will supply to the German government if needed,” explained Michael Quirmbach, CEO & President of CordenPharma. “We are proud to contribute to supply security in Germany.”

WACKER has operated a biotech site on Weinberg Campus (a technology park) in Halle, Germany, since 2014. The capacity expansion for pandemic preparedness is part of a major expansion project. “We are expanding our Halle site into a competence center for mRNA production. We are creating capacity not only for pandemic preparedness, but also beyond that,” said Susanne Leonhartsberger, head of WACKER BIOSOLUTIONS. The aim, she adds, is to expand production to a total of four production lines. WACKER intends to hire over 200 new employees as part of the Halle site’s expansion. During a Capital Market Day at the end of March, WACKER announced that it would significantly increase its investments in the further growth of its biotechnology business. To this end, WACKER intends to invest over €80 million annually in the coming years.

WACKER and CordenPharma will keep production capacity available from 2024, the start of the stand-by phase. Should the need arise, the German government will contact the developer of the specific mRNA vaccine that is required. WACKER and CordenPharma will then jointly produce this mRNA vaccine. Most of the production steps will take place in Germany and every production step will occur within the European Union.

In Halle, WACKER will produce plasmid DNA (pDNA), which is an essential starting material for the manufacture of mRNA. The mRNA active based on pDNA will also be produced there. Halle is also where formulation using Lipid NanoParticles (LNP) of the mRNA active will take place. Halle is creating capacity for these three production steps. Other WACKER sites will assist to rapidly establish the required technological expertise for the production of pDNA and mRNA in Halle.

CordenPharma, for its part, will produce not only standard lipids, but also custom lipids for LNP formulation. Lipid NanoParticles consist of special fats (lipids), which encapsulate the active and ensure that it is safely transported into the body cells. In addition, CordenPharma will handle the aseptic filling and packaging of the mRNA vaccine produced and formulated in Halle. When needed, WACKER and CordenPharma will jointly supply the German government with 80 or 100 million vaccine doses per year.

About Wacker Biotech

The Munich WACKER Group concentrates its biopharmaceuticals activities within Wacker Biotech. Wacker Biotech GmbH, Wacker Biotech B.V. and Wacker Biotech US Inc. are full-service contract manufacturers of therapeutic proteins, live microbial products (LMPs), plasmid DNA (pDNA), messenger ribonucleic acid (mRNA) and vaccines based on microbial systems. Wacker Biotech’s portfolio extends from strain/process development and analytical testing through to production for clinical and commercial applications. Wacker Biotech maintains three GMP-compliant (Good Manufacturing Practice), FDA- and EMA-certified production plants at its Jena and Halle sites in Germany and in Amsterdam in the Netherlands. In addition, Wacker Biotech has had a plant in San Diego (Wacker Biotech US Inc.) since February 2021. Wacker Biotech GmbH, Wacker Biotech B.V. and Wacker Biotech US Inc. are wholly owned subsidiaries of Munich-based Wacker Chemie AG. For more information, visit: wacker.com/biologics

About CordenPharma

CordenPharma, the global pharmaceutical service & manufacturing platform of International Chemical Investors Group (ICIG), is a full-service partner in the Contract Development & Manufacturing (CDMO) of APIs, Drug Products, and associated Packaging Services. Through a growing network of cGMP facilities across Europe and the US organized under five Technology Platforms – Lipids & Carbohydrates, Peptides, Injectables, Highly Potent & Oncology, and Small Molecules – CordenPharma experts translate complex processes and projects at any stage of development into high-value products. For more information, visit: cordenpharma.com