Evonik Expands Formulation Capabilities for Lipid Nanoparticles

Collaboration with KNAUER aims to streamline and improve the scale-up of LNP formulations for mRNA and gene therapies.

Evonik is collaborating with KNAUER Wissenschaftliche Geräte GmbH, a manufacturer of scientific instruments, to improve the scale-up of lipid nanoparticle (LNP) formulations. Combining Evonik’s formulation and scale-up expertise with KNAUER’s technological know-how, aims to improve efficiency and increase speed to market, cutting the initial preclinical development time.

Nucleic acid therapeutics represent growing proportion of the overall parental drugs market. Evonik supplies pharmaceutical companies worldwide with lipids and LNP drug product development activities. The LNP market alone is estimated to be more than $600 million and is projected to grow over the next decade.

"Together with KNAUER, we can increase the speed with which we go from very small-scale prototypes to production-scale lead formulations, and then directly into GMP production of drug products,” said Andrea Engel, head of Growth Projects Evonik Health Care.

KNAUER is known for its high-end scientific instruments used in research and commercial applications. Recently, Evonik implemented KNAUER’s IJM NanoScaler Pro technology, which addresses the long-standing challenges in nucleic acid LNP formulations by reducing the need for labor-intensive and time-consuming experiments, thereby reducing the time and material costs associated with screening for optimal LNP formulations on platforms that do not necessarily upscale when introduced into more proven IJM large scale systems.

"By working hand-in-hand with Evonik, we are confident that our areas of expertise complement each other, and that exceptional formulation and technology will lead to improved patient outcomes," said Anja Fuss, head of Purification & Customized Solutions at KNAUER. 

Evonik Vancouver Laboratories provides early-stage development, scale-up and production of lipid-based formulations for gene  delivery and other advanced nanomedicines. It complements Evonik’s global lab and production network, which includes a cGMP facility in Hanau, Germany, for the development and manufacture of small batches of lipids for clinical and small-scale commercial manufacturing. Construction is also underway at Evonik’s Tippecanoe, IN site, for a new manufacturing facility for the rapid scale-up and production of specialty lipids.


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