Evonik – Now also a global CDMO for lipid nanoparticles

INTEGRATED CDMO SERVICES FOR LIPID-NANOPARTICLE-BASED GENETIC DRUGS AND OTHER NANOMEDICINES SINCE THE 1990S

Evonik Vancouver Laboratories, formerly known as Transferra Nanosciences Inc. or Northern Lipids, has been a market CDMO leader for lipid nanoparticle (LNP)-/liposome-based formulations for almost 30 years. We have an unparalleled track record in early stage development, scale-up and production of lipid-based formulations for gene-based therapies and other advanced nanomedicines. As a specialist CDMO for lipid nanoparticles (LNPs) with a broad base of pharmaceutical and biotech clients across the world, we have accumulated extensive expertise across virtually all classes of pharmaceuticals. Hundreds of LNP-based formulations have been developed by us to-date, including oncology, vaccines, nucleic acids (mRNA, DNA, siRNA), ligand-targeted formulations and imaging contrast agents. We are also leading the CDMO market for LNPs to address emerging areas of market need including drug combinations, immunotherapies and individualized treatments.

How lipid nanoparticles (LNPs) safely deliver mRNA to human cells

CDMO LNP SERVICES: INTEGRATED SUPPORT FROM FEASIBILITY TO SCALE-UP AND COMMERCIAL SUPPLY

As a CDMO for LNP-based drug delivery, we bring together a range of market-leading drug discovery and pre-clinical services that can reduce risk and streamline your path to commercial launch. We have extensive expertise in early stage formulation development, including the choice of lipid excipients and appropriate buffer systems, preparation and characterization of nanoparticle prototypes for feasibility testing. Other common R&D-stage CDMO services for LNPs include the identification of the most scalable manufacturing process, the development of analytical methods, and the co-ordination of stability studies to establish storage conditions. Preclinical program activities include scale-up and manufacturing for GLP toxicology, analytical method development for long term stability studies, test article preparation for IND enabling toxicology studies, and the development of drug product specifications.

• Flexibility to choose manufacturing process best suited to a specific LNP formulation, whether it’s conventional liposomes manufactured using particle size reduction process like extrusion, or nucleic acid LNPs using a variety of rapid mixing technologies.

OUR CDMO LNP SERVICES WILL OPTIMIZE YOUR FORMULATION AND PROCESS DEVELOPMENTS

From entry into clinical drug trials to the commercial supply of the finished product, a range of additional services are available to CDMO LNP project customers including formulation and process optimization using QbD principles, phase specific method validation based on ICH guidelines, drug product release testing and stability studies, and cGMP manufacturing and aseptic filling. Based upon your API and other drug product requirements, we will identify and develop the most effective and scalable manufacturing process. To reduce scale-up and regulatory risk, this process will be based not only upon our comprehensive understanding of the critical process parameters that impact performance, but also our strong manufacturing knowhow based upon countless other CDMO LNP-based projects.

CDMO LNP SERVICES: PROCESS TECHNOLOGIES FOR CGMP MANUFACTURING

Evonik has set the CDMO standard for conventional extrusion-based LNP drug product manufacturing for more than 25 years. Our LIPEX® platform of extruders can create homogeneous populations of liposomes. A one-step process forces aqueous suspensions of lipids through filters with a defined pore size for optimal size reduction and trapping efficiency. LIPEX® extruders can be supplied in a range of sizes for lab-scale, pilot, intermediate and commercial-scale use.

For nucleic acids LNPs Evonik and its partners also have utilized various rapid-mixing technologies, whereby homogenous populations of particles are created via controlled solvent dilution.

AS A CDMO EXPERT WE PROVIDE MODERN, ESTABLISHED SITES FOR LNP MANUFACTURING AND FILLING

As a CDMO expert for LNPs and other complex parenteral drug products, we bring together the large-scale and specialized capabilities that are necessary to meet all of your clinical and commercial batch requirements. cGMP manufacturing of LNP-based drug products for pre-clinical and clinical use including Phase I to II trials, long-term stability studies and the validation of analytical methods can be conducted at our modern, recently expanded facilities in Vancouver, Canada. The Vancouver site features an ISO 7 compounding area with an established capability for ISO 5 aseptic filling. The site is also equipped for the handling of high potency APIs. For Phase III and commercial supply of LNP products, CDMO activities relating to cGMP manufacturing and aseptic filling can be seamlessly transferred to our facilities in Birmingham, Alabama.

ANALYSIS AND TESTING FOR CDMO LNP SERVICES

Our modern laboratories in Vancouver, British Columbia and Birmingham, Alabama provide a comprehensive range of analytical development and quality control services to support projects from feasibility through to clinical and commercial supply. Services include method development, validation according to ICH guidelines, lipid excipient testing, raw material and drug product release testing, and stability storage testing. A broad range of analytical testing capabilities including dynamic light scattering, various chromatographic capabilities, as well as bioanalyzer analysis of nucleic acids are available to support formulation characterization.

See also the EVONIK Excipients Offering