The ‘lipid launch facility’ can supply lipids for clinical and small-scale commercial manufacturing: thus complementing the company’s existing lab and commercial production capabilities.
Lipids produced at the site will serve a broad range of RNA and gene therapies such as infectious disease control, cancer immunotherapy and protein replacement therapies. With particle engineering and purification capabilities, including chromatography, the lipid launch facility can support customers with production of all types of custom and proprietary lipids, including PEGylated lipids, phospholipids, and ionizable cationic lipids.
Lipids make up the 'building blocks' of living cells and are critical for mRNA-based drugs.
mRNA is enclosed in a lipid nanoparticle (LNP) composed of specific lipids. This protects the mRNA from degradation and delivers it into the cell, where it is released.
"LNPs are currently the most advanced drug delivery system and have gained worldwide acceptance in the fight against COVID-19 due to their versatility," notes Evonik.
“Our offering allows customers to obtain high quality GMP material consistent with larger scale production, enabling a seamless path for scale up – allowing our partners to move quickly in this fast-paced development space,” said Paul Spencer, head of Drug Delivery & Products at Evonik’s Health Care business.
The opening of the lipid launch facility – which was celebrated with an official inauguration yesterday (March 8) - is the latest in a series of investments by Essen, Germany-headquartered Evonik in lipid manufacturing for RNA and gene therapies.
Last year, the company announced a $220m investment in partnership with the US government in a new lipid production facility at its site in Tippecanoe, Indiana: positioning it for future growth in novel mRNA-based therapies beyond COVID-19 vaccines.
Evonik also increased production capacities for the plant-derived cholesterol PhytoChol - a key lipid used in lipid nanoparticles - at its Hanau site in Germany.
Meanwhile, the company’s laboratories in Vancouver work on preclinical development and clinical manufacturing for lipid-based, parenteral drug formulations, including LNPs and liposomes.