Evonik is building a new cGMP facility in Hanau, Germany to manufacture lipids for clinical development and launch of innovative medicines.
 
The new cGMP lipid launch facility will provide customers with smaller batch sizes of lipids as needed for clinical development. This cGMP expansion enhances the current gram-scale development lab and enables Evonik to meet the needs of partners at every stage of commercialization.
 
With particle engineering and purification capabilities, including chromatography, the new facility can support customers with production of all types of custom and proprietary lipids, including PEGylated lipids, phospholipids, and ionizable cationic lipids. Start of operation is planned for the beginning of 2023.

Enhancing Comprehensive Lipid Capabilities

The lipid launch facility will further expand Evonik’s integrated portfolio of System Solutions for advanced drug delivery of mRNA and nucleic acid therapies including siRNA, oligonucleotides, and gene delivery. These are crucial for medicines of the future.
 
With the new lipid launch facility, Evonik continues its commitment to this important technology, offering end-to-end solutions for pharma and biotech companies from pharmaceutical formulation up to large-scale commercialization.
 
In June this year, Evonik announced a triple-digit million-dollar joint investment with the U.S. Government to build a new lipid production facility at its site in Tippecanoe in Indiana, U.S. At the beginning of 2022, 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.
 
“With our new capability to produce kilogram quantities in Hanau, we are excited to offer our pharma customers more of the lipids they want in the amounts they require. We are confident this will contribute to the success of clinical studies and, ultimately, the approval of more new therapies,” says Thomas Riermeier, head of Evonik’s Health Care business.
 
The types of lipids that can be produced at the kilogram scale will serve a broad range of mRNA and gene therapies such as infectious disease control, cancer immunotherapy, protein replacement and gene therapy. The lipid launch facility will now allow customers to obtain cGMP material consistent with larger scale production, enabling a seamless path for scale up.
 
This consistency across different scales from development to commercial production allows customers to gain important information, for example, on impurities or toxicological properties that are otherwise difficult to test at laboratory scale.
 
“We continue to enhance our offering as a reliable partner by developing and producing custom and proprietary lipids for leading players to help them realize the potential of gene therapies. Our lipid launch facility now provides our customers with tailored solutions for higher efficiency in early development stages,” says Paul Spencer, head of Drug Delivery & Products at Evonik’s Health Care business.