• Establishment of additional lipid production in Germany for use with mRNA-based vaccines
• Expansion of leading position as integrated development and manufacturing partner in cell and gene therapies
• Increased supply security of Pfizer-BioNTech COVID-19 vaccine

Essen, Germany. Evonik is investing in the short-term expansion of its specialty lipids production which are essential for mRNA-based COVID-19 vaccines. Commercial lipid quantities are to be produced at Evonik’s Hanau and Dossenheim sites in Germany as early as the second half of 2021 as part of a strategic partnership with vaccine manufacturer BioNTech. Evonik is making an important contribution to increasing the supply security of the Pfizer-BioNTech COVID-19 vaccine.

"The pandemic requires decisive action," says Christian Kullmann, chairman of Evonik’s executive board. "We are therefore doing everything possible to supply our partners with the critical lipids they need. At the same time, we are expanding our production capacity and competencies along the entire value chain."

Lipids are fundamental to produce highly effective mRNA-based vaccines. Only with an increase in lipid supply can the volume of vaccine be further increased. This move marks an expansion of the strategic partnership between Evonik and the vaccine manufacturer BioNTech.

In mRNA-based vaccines, the mRNA is enclosed in a lipid nanoparticle (LNP) that is comprised of specific lipids. The LNP protects the mRNA and delivers it safely into the cell. There it is released so that the vaccine can exert its effect. Evonik has been a contract development and manufacturing organization (CDMO) leader for advanced drug delivery for many decades, supporting pharmaceutical companies worldwide in the development and production of complex parenteral drug products that require formulation technologies such as lipid nanoparticles.

The Germany-based company is one of the few integrated development and manufacturing partners for cell and gene therapies, and has been actively involved in various mRNA-based vaccines projects for COVID-19.

"With our partnership with BioNTech, we are systematically expanding our leading position as an integrated development partner in cell and gene therapies," says Thomas Riermeier, head of Evonik's Health Care business line. Evonik’s portfolio includes pharmaceutical excipients such as lipids, as well as CDMO services for the formulation development, GMP manufacturing and aseptic filling of complex parenteral drug products.”

The COVID-19 vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States, United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

The Evonik Health Care business line, which includes products, services and technologies for cell and gene therapies, has been characterized by strong growth and high innovation power for many years. Evonik recognized the potential of gene-based therapeutic approaches early in the emergence of these advances. For example, the specialty chemicals company already develops and formulates lipid nanoparticles in Burnaby, Canada, and operates a facility for the production and fill-finish of commercial quantities in Birmingham, Alabama, USA. "We made a targeted investment in this promising technology in 2016 with the acquisition of Burnaby-based Transferra Nanosciences," Riermeier explains. The portfolio was further expanded at the beginning of 2020 with the acquisition of Wilshire Technologies, an American manufacturer of non-animal derived excipients for the pharmaceutical industry. This includes PhytoChol®, a non-animal derived cholesterol, used in many commercial parenteral pharmaceutical products.