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
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.
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