Evonik has announced an investment in short-term expansion of its specialty lipids production which are needed 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.
"The pandemic requires decisive action," said 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."
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.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from Pharmaceutical Outsourcing – all delivered right to your inbox! Sign up now!
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," said 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.