Stirring success: How to overcome hurdles in large-scale lipid nanoparticle (LNP) formulations

Overview

Lipid nanoparticle (LNP) formulation processes begin on a small scale, often with homemade or bench-top setups, using syringe pumps and easily accessible micro-mixing systems. Once a promising formulation has been identified, the next step is to transition to standardized large-scale impingement mixing systems. In this webinar, our experts outline the factors that formulators need to consider when scaling up novel LNP systems. Learn about parameters that affect LNP formation, such as flow rate, solvent removal, buffer exchange, and the risk factors when changing equipment.. Whether you work in formulation, R&D, or business development, this webinar will help you navigate the many hurdles of LNP scale-up.

In this webinar you will learn about:

Limitations of bench-top processes for large-scale manufacturing
The challenges of scaling LNP formulations
Physiochemical properties and the manufacturability of mRNA-LNP formulations

Experts featuring this session

Dr. Michael Parr
Director Formulation and Process Development
Evonik Health Care
Vita

Dr. Michael “Mike” Parr joined the Production & Technology team of Evonik’s Health Care business line in 2021 as director of formulations and process development for the Vancouver site. Mike is responsible for leading multifunctional teams and ensuring the successful execution of a portfolio of complex customer-funded development programs as part of the parenteral drug delivery solutions business.

Mike has more than 20 years of experience in the pharmaceutical industry including roles at Sitka Biopharma, CDRD Ventures Inc., Angiotech and Biogen Idec. His areas of expertise include liposomal drug delivery systems, formulation, molecular biology, GLP, GMP activities and clinical development. Mike holds a B.Sc. Honours and Ph.D. in Biochemistry and Molecular Biology from The University of British Columbia in the laboratory of Dr. Pieter Cullis and he completed post-doctoral studies at Harvard Medical School.

Dr. Alex Leung
Scientist, Formulation and Process Development
Evonik Health Care
Vita

Dr. Alex Leung is a scientist working in Formulation and Process Development at Evonik, based in Vancouver, Canada. With interests in preclinical drug development and personalized medicine, Alex’s expertise is in the field of nanoparticle drug delivery technologies. His focus is on developing scale-up processes and creating innovative lipid-based nucleic acid delivery systems aimed at advancing gene therapy applications.

Prior to joining Evonik in 2020, Alex was a Michael Smith Foundation for Health Research (MSFHR) Research Trainee at the Centre for Heart Lung Innovation, where he investigated the roles of lipids and lipoproteins on the pathology of sepsis. Alex holds a Ph.D. in biochemistry and molecular biology from The University of British Columbia in the laboratory of Dr. Pieter Cullis, where he co-developed the microfluidic mixing technique for the encapsulation of siRNA into lipid nanoparticles (LNP) and studied the structural properties of LNP-based delivery systems of various nucleic acids.