Your leading integrated CDMO for RNA-based therapies
Lipids are one of the pillar excipients for drug delivery systems and are especially important for RNA-based therapies such as mRNA vaccines. At Evonik Health Care, we are specialists in the technologies required to supply leading pharmaceutical companies worldwide with the lipids they need.
Our broad range of capabilities complement our expertise in formulation and process development of mRNA-based formulations.
As a CDMO partner offering end-to-end solutions, we can meet your needs through:
- GMP (Good Manufacturing Practice) manufacturing capabilities at any scale
- Decades of experience in route scouting, process development, optimization, isolation, and purification of GMP products including lipids and active pharmaceutical ingredients (APIs)
- Experienced in development and validation of analytical methods
- Engineering expertise and chemical production excellence
- Backward-integration: fats, PEGs and other key raw materials
- Regulatory and application know-how for pre-clinical, clinical trial, and commercial launch lipid supplies
Our network of technologies enables fast production of custom lipids
The purification and isolation of lipids presents key manufacturing challenges. We use our broad portfolio of interdisciplinary technologies and core competencies to enable the fast production of custom lipids.
Our technologies include:
- Route scouting and pharmaceutical process development, and GMP manufacturing assets
- Purification technologies – purification processes by chromatography from lab to 100 kg+ scale
- Thermal process separation – distillation (batch and continuous, short-path, thin-film, wiped-film and melt crystallization).
- PEGs and mPEGs – development and manufacturing of PEGs/mPEGs for backwards integration for PEG lipids.
- Particle engineering and isolation – crystallization, milling, spray and freeze-drying technologies for facile isolation and to control product properties.
- Lipid plants that enable fast setup of required technologies
At Evonik Health Care we have a pool of available assets ready for fast setup. These complement our established company-wide network and expertise.
Our assets include:
- Multi-purpose GMP plants
- GMP lab
- Isolation and drying equipment
- Distillation equipment
- GMP Chromatography equipment from lab scale to 100 kg+
- Freeze drying
- Analytical expertise/equipment (e. g. CAD detectors)
Chromatographic excellence as a powerful separation tool for lipids
Chromatography is an essential purification technology at Evonik Health Care. Evonik has an expert chromatography group focusing on process development of Good Manufacturing Practice (GMP) products at any scale. Thus, Evonik has the required know-how and expertise in all kinds of related separation techniques, reaching from ion exchange, normal phase and reversed phase to affinity chromatography. Additionally, if necessary, we are able to develop continuous chromatography (simulated moving bed) for further process optimization.
The following are some examples of application of chromatography in production:
- Demineralization of neutral molecules
- Separation of products with different pKa by controlled ion exchange (e.g. amino acids)
- Purification by flash chromatography
- Separation by adsorption or ion exclusion
Interdesciplinary technologies ensuring delivery of the quality you need, on time
We made a critical contribution to mRNA COVID-19 vaccine availability by significantly increasing the production of three critical lipids needed for lipid nanoparticles (LNPs) in record time. Evonik is continuing to expand our lipid development and manufacturing capabilities in our sites in Hanau, Dossenheim in Germany and Tippecanoe in Indiana in the U.S.
Expansion is in progress for additional capacity to support small scale GMP lipid manufacturing at our site in Hanau. This lipid launch line facility will be up and running from 2023.
We are also building a new lipid production facility for large-scale commercial production of lipids at our site in Tippecanoe.
For details about our lipid development and manufacturing expertise, please see:
Your partner for high-quality GMP lipids
More than 30 years’ experience with lipid nanoparticles (LNPs) and other nanomedicines ... MORE
To find out more about our technologies for the purification of lipids, get in touch:
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