Press Release > Pandemic Preparedness: WACKER & CordenPharma Will Produce mRNA Vaccines for Germany When Needed

CordenPharma will produce standard and custom lipids for LNP formulation and the aseptic filling and packaging of the mRNA vaccines.

11 April 2022 - Munich / Halle / Plankstadt

WACKER AND CORDENPHARMA TO BECOME PART OF GERMANY’S PANDEMIC PREPAREDNESS PLANTHE TWO COMPANIES WILL BE READY TO PRODUCE MRNA VACCINES FOR THE GERMAN GOVERNMENT IF THE COVID-19 PANDEMIC CONTINUES OR A NEW PANDEMIC OCCURS
WACKER AND CORDENPHARMA JOINTLY COVER THE ENTIRE MANUFACTURING CHAIN FOR VACCINES
HALLE WILL BECOME A COMPETENCE CENTER FOR PRODUCING MRNA VACCINES, WITH ADDITIONAL CAPACITY FOR OTHER CUSTOMERS AS WELL
CORDENPHARMA WILL USE ITS YEARS OF EXPERIENCE IN PRODUCING CUSTOM AND STANDARD LIPIDS AND IN FILL & FINISH
WACKER INTENDS TO INVEST OVER €80 MILLION ANNUALLY IN EXPANDING THE GROWTH OF ITS BIOTECHNOLOGY BUSINESS OVER THE NEXT FEW YEARS

In order to accommodate a large spike in the demand for peptide APIs, and to continue an overall growth strategy, CordenPharma Colorado recently completed expansion of their solid-phase peptide manufacturing capacity. Dr. Matthieu Giraud, Director, Global Peptides, Lipids & Carbohydrates Platform, explains: “With the addition of this extra-large 3’000 L SPPS vessel, our assembly-time, capacity and flexibility has been significantly increased, reinforcing CordenPharma Colorado as the current large-scale peptide manufacturing capacity leader. This new asset gives us the ability to manufacture a complex long peptide with a 400 kg output per single batch. Our team in Colorado aims to utilize this new capacity to conduct validation campaigns designed to support customer projects with a global impact.”

As a consequence of the initial vaccine shortages in the coronavirus pandemic, the German government is securing vaccine production and supplies for the years ahead. Pharmaceutical producers with appropriate vaccine expertise and capacity were invited to apply for stand-by production agreements with the German government.

As joint bidders, WACKER and CordenPharma applied for the stand-by production of vaccines based on messenger ribonucleic acid (mRNA). 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 raw 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.