Gene delivery is rapidly evolving and has great potential to treat a range of acquired and hereditary disorders, from cancer and metabolic disorders to infectious diseases. LNPs enable the transport & delivery of a variety of molecules, including RNA, to cells and are therefore a crucial tool in gene delivery.
Evonik has over three decades of experience formulating a variety of different lipids and liposome carriers and manufactures lipids, e.g. used in mRNA COVID-19 vaccines including PhytoChol® plant-derived cholesterol and several custom lipids in partnership with BioNTech. We can work with you to develop and manufacture the lipid you need, saving you time and ensuring the success of your project.
The quality of lipids in a lipid nanoparticle assembly is critically important to the functionality of mRNA-based therapeutics. We have identified a key impurity in cationic lipids, N-Oxide, that is responsible for a loss in transcription and translation activity of the mRNA cargo. This study demonstrates that Evonik is capable of manufacturing high-quality lipids with a purity greater than 99% and a consistently low level of the N-Oxide impurity.
Superior development capabilities for customized lipids
We harbor a deep understanding of liposomes and LNPs, including formulation, scale up, and characterization, and as a result we recognize the crucial role of lipids in these formulations. We support our clients with custom lipid projects by combining this understanding with decades of expertise in process development, analytics, scale up, validation and GMP manufacturing. Regardless of your current scale and requirements, Evonik can support with non-GMP and GMP capabilities from small scale through large scale production.
We provide an integrated solution that unites all these capabilities in one package.
- Chemical process R&D: route scouting, process development, process transfer into the plant and manufacturing support.
- Catalysis: screening and development of homogeneous & heterogeneous catalytic reactions for large-scale production.
- Flow chemistry: development of continuous processes for intermediates and final products for pilot and large-scale production.
- PEGs and mPEGs: development and manufacturing of PEGs/mPEGs for corresponding backwards integration into key raw materials for PEGylated lipids
- Purification technology: purification processes by chromatography from lab to multi-ton scale.
- Thermal process separation: distillation (e.g. batch, continuous, short-path, thin-film, wiped-film), melt crystallization.
- Particle engineering: crystallization, milling, spray drying technologies to control polymorphism, particle size, purity and other properties.
- Analytical: wide range of analytical capabilities required for lipid characterization, expertise in development or transfer of methods, including method validation
A broad, flexible range of services for your lipid demand
To ensure seamless project support from feasibility to launch, we offer a broad range of services for early to late-stage projects. These include:
- Launch-focused process development and scale-up
- Analytical method development services
- Identification & characterization of side products & impurities
- Extensive process validation and stability support
- Non-GMP samples for compatibility studies
- cGMP manufacturing at any scale
- Established QA system (cGMP and IPEC GMP)
- Regulatory support including DMF preparation and filing
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