Parenteral Drug Delivery - Lipid-based

The pharmaceutical landscape is undergoing a transformation with the rise of nucleic acid therapeutics. Unlike traditional drugs,nucleic acid therapies such as mRNA enable the patient's body to produce therapeutic proteins directly, offering faster development, cost efficiency, and personalized treatment options. This technology has already proven its potential in COVID-19 vaccines and is expanding into areas like cancer immunotherapy, protein replacement, and gene editing.

Lipid nanoparticles (LNPs) are the gold standard for delivering nucleic acids such as RNA into cells. They protect the fragile RNA from degradation, facilitate cellular uptake, and ensure efficient release inside the target cells. LNPs are composed of multiple lipid types that work together to encapsulate and deliver nucleic acids safely and effectively.

A standard LNP formulation includes:

• Ionizable Cationic Lipid (~50%) – complexes nucleic acids and facilitates endosomal escape
• Structural Lipid (~10%) – ensures particle stability (e.g., DSPC, DOPE)
• Cholesterol (~38.5%) – enhances encapsulation and transfection efficiency
• PEG Lipid (~1.5%) – stabilizes particles and controls size
• Nucleic Acid Payload – the therapeutic RNA

Lipid-based systems offer several advantages:

• Improved safety and reduced toxicity
• Targeted delivery and controlled release
• Enhanced bioavailability and intracellular delivery
• Biocompatibility and reduced immune response
• Established design principles and manufacturing techniques

These benefits make lipid-based carriers ideal for a wide range of therapeutic applications, from small molecules to complex biologics.

Evonik is a fully integrated development partner for nucleic acid-LNP therapeutics, offering:

• Excipient supply (e.g., plant-derived cholesterol, PEG lipids)
• Formulation development using advanced mixing technologies
• Clinical and commercial manufacturing at GMP-certified sites
• Analytical and regulatory support

With over 30 years of experience in lipid-based drug delivery and more than 100 LNP projects, Evonik supports clients from concept to commercialization.

Evonik offers a comprehensive lipid portfolio through catalog products, custom development, and CDMO services.

• PhytoChol® – Plant-derived cholesterol
• PhytoSquene® – Squalene
• ALC-0159* – PEG-Lipid
• ALC-0315* – Ionizable lipid
• Northern Lipids® DMG-mPEG 2000 – PEG lipid
• Northern Lipids® R-DOTMA – Cationic lipid

* Limited R&D quantities available without license; GMP versions require licensing.

Evonik provides tailor-made lipid solutions with:

• Decades of formulation expertise
• Process development and scale-up capabilities
• GMP and non-GMP manufacturing at any scale
• Advanced purification and particle engineering technologies

From route scouting to commercial production, Evonik ensures quality, speed, and flexibility for your lipid needs.

Alongside catalog and custom lipids, Evonik offers LIPEX® extruders for producing homogeneous lipid-based formulations, including liposomes and LNPs. These systems enable scalable, solvent-free extrusion from lab to commercial scale, ensuring high encapsulation efficiency and consistent particle size. LIPEX® technology supports rapid development and reliable manufacturing of complex parenteral drug products.

While lipid nanoparticles are central to nucleic acid delivery, Evonik’s lipid portfolio extends beyond LNP applications. PhytoSquene®, a plant-derived squalene, offers a sustainable alternative to animal-based squalene for use in other lipid-based formulations, such as emulsions and adjuvants. It meets stringent pharmacopeial standards and supports the development of biocompatible and eco-conscious drug delivery systems.

• Global CDMO leadership in complex parenterals
• Integrated services from formulation to fill-finish
• Western-based GMP sites in Canada, USA, and Germany
• Trusted supplier of high-purity excipients
• Innovative technologies like LIPEX® extruders and microfluidic mixing