Evonik Expands Formulation Capabilities for mRNA and Gene Therapy Lipid Nanoparticles

Evonik is teaming up with KNAUER Wissenschaftliche Geräte GmbH, a leader in scientific instruments, to enhance the scaling up of lipid nanoparticle (LNP) formulations. This partnership combines Evonik’s expertise in formulation and scaling with KNAUER’s advanced technology, allowing customers to boost efficiency and accelerate time-to-market, which will significantly shorten the initial pre-clinical development phase.

As part of Evonik’s Nutrition & Care division, the Health Care business is expanding its biosolution portfolio through collaborations with life science and industry leaders, focusing on innovations in nucleic acid-based medicines.

Yann d’Hervé, head of Evonik’s Health Care business line, stated, “Our deep knowledge in chemistry and formulation science has allowed us to capture a large share of the growing market for mRNA and gene therapies. Our partnership with KNAUER enhances our ability to offer unique differentiation options.”

Nucleic acid therapeutics are rapidly growing within the broader pharmaceutical market. Evonik provides lipids and LNP drug product development services to pharmaceutical companies globally. The LNP market is valued at over $600 million, potentially reaching $1 billion, with expected continued growth in the coming decade.

Andrea Engel, head of Growth Projects at Evonik Health Care, noted, “Collaborating with KNAUER enables us to accelerate the transition from small-scale prototypes to production-scale formulations, and seamlessly move into GMP production of drug products.”

KNAUER is renowned for its high-quality scientific instruments used in both research and commercial settings. Recently, Evonik adopted KNAUER’s IJM NanoScaler Pro technology, which addresses challenges in nucleic acid LNP formulations by minimizing labor-intensive and time-consuming experiments. This innovation reduces both time and material costs associated with optimizing LNP formulations, especially when scaling up from experimental platforms to larger IJM systems.

Anja Fuss, head of Purification & Customized Solutions at KNAUER, expressed confidence in the collaboration: “Our combined expertise will lead to exceptional formulation and technology, ultimately improving patient outcomes.”

Lipids are fundamental to cell function and critical for the effective encapsulation and delivery of mRNA and other nucleic acid-based drugs. LNPs, composed of specific lipids, protect nucleic acids from degradation and ensure their safe delivery into cells. These advanced drug delivery systems have played a crucial role in the global response to COVID-19.

Evonik Vancouver Laboratories, previously Transferra Nanosciences Inc. or Northern Lipids, has been a key player in LNP/liposome-based formulation development for nearly 30 years. The site excels in early-stage development, scale-up, and production of lipid-based formulations for gene delivery and advanced nanomedicines. This complements Evonik’s global lab and production network, which includes a cGMP facility in Hanau, Germany, for clinical and small-scale commercial manufacturing. Additionally, a new manufacturing facility for the rapid scale-up and production of specialty lipids is under construction at Evonik’s Tippecanoe site in Indiana, USA.

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