New GMP facility for clinical and small-scale commercial pharmaceutical lipids
Supports all types of custom and proprietary lipids
Reinforces Evonik’s position as integrated solutions provider for RNA and nucleic acid therapies
Evonik is opening a new GMP facility to manufacture lipids for advanced, pharmaceutical drug delivery applications. The lipid launch facility is located at the company’s site in Hanau, Germany and provides customers with quantities of lipids as needed for clinical and small-scale commercial manufacturing. The new facility complements Evonik’s existing lab and commercial production capabilities to meet the needs of partners at every stage of development and commercialization. Official inauguration of the facility took place on 8 March 2023.
“We are excited about the timely opening of our new facility. Our customers benefit from our expanded integrated portfolio of System Solutions for advanced drug delivery, enabling the development of novel nucleic acid therapies and other medicines of the future,” said Thomas Riermeier, head of Evonik's Health Care business.
The types of lipids that can be produced at Evonik’s lipid launch facility 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.
“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 is the latest in a series of investments by Evonik in lipid manufacturing for RNA and gene therapies. Last year, the company announced a triple-digit million-dollar joint investment with the U.S. Government to build a new lipid production facility at its U.S. site in Tippecanoe in Indiana. Evonik also increased production capacities for the plant-derived cholesterol PhytoChol® - a key lipid used in lipid nanoparticles - at its Hanau site in Germany. Evonik’s laboratories in Vancouver have been working on preclinical development and clinical manufacturing for lipid-based, parenteral drug formulations, including LNPs and liposomes, for over three decades.
Lipids make up the building blocks of living cells and are critical for mRNA-based drugs. The mRNA is enclosed in a lipid nanoparticle (LNP) composed of specific lipids. This LNP protects the mRNA from degradation and delivers it safely 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.
As a partner to the pharmaceutical industry, Evonik has been a leader in advanced drug delivery for decades. It supports pharmaceutical companies worldwide with comprehensive services for developing and manufacturing complex parenteral and oral drug products. This includes pharmaceutical excipients such as polymers and lipids, formulation development and the manufacturing of clinical samples, as well as commercial drug products.
Evonik’s Health Care business is part of the company’s life sciences division Nutrition & Care, which aims to increase its share of System Solutions from 20 percent today to more than 50 percent by 2030. These are multi-component offerings across products, technologies and services that provide customers with end-to-end development and manufacturing services.