Addressing the Challenges of LNP Upscaling: A Reynolds Number-Driven Approach via Junction Mixing Technologies

The transition from the laboratory scale lipid nanoparticle formulation to clinical and industrial production presents significant challenges in maintaining particle uniformity, encapsulation efficiency, and process reproducibility. Scale-dependent shifts in fluid dynamics often disrupt critical quality attributes (CQAs), limiting the reliable production of mRNA-based therapeutics.

This webinar explores how junction mixing technologies – particularly Impingement Jets Mixing (IJM) – offer scalable, physics-informed solutions. By aiming for constant flow conditions in IJM Mixers as a predictive parameter for flow regime characterization, IJM enables controlled turbulence and reproducible mixing across development stages. KNAUER’s modular systems cover everything from the NanoScaler for R&D to benchtop unit for clinical batches and large-scale platforms for GMP-compliant vaccine production.

We will present a framework for integrating fluid mechanical principles into formulation design, share empirical correlations between Reynold’s number and LNP quality outcomes, and discuss how KNAUER’s systems support safe, reproducible upscaling in RNA therapeutics. Attendees will gain insights into bridging engineering and pharmaceutical innovation – from discovery to global deployment.

Key Learning Objectives:

• Identify scale-dependent challenges in LNP formulation and understand how fluid dynamics influence critical quality attributes (CQAs) during the transition from lab-scale to GMP-compliant production.
• Evaluate the role of Impingement Jets Mixing (IJM) in achieving reproducible mixing turbulence, using constant flow conditions as predictive parameters for flow regime characterization.
• Apply fluid mechanical principles to formulation design and explore how KNAUER’s modular systems support safe, efficient, and scalable production of RNA therapeutics from R&D to industrial deployment

Presenter: Dr. Paul Pietsch (Global Engineering Solutions Manager, KNAUER)

Dr. Paul Pietsch studied Food Technology at the Anhalt University of Applied Science before going on to complete an engineering Ph.D. at the Technical University of Berlin. Following completion of his doctorate, Dr. Pietsch joined the team at KNAUER as a product manager for their continuous chromatography systems. After 3 and a half years in this role, he moved on to become the Global Engineering Solutions Manager across the LNP business.

Presenter: Lilit Avagyan (Team Leader, Customized Solutions, KNAUER)

Lilit Avagyan is a pharmaceutical chemist with a research background in developing active pharmaceutical ingredients for breast cancer therapy. She has over 13 years of experience at KNAUER in experimental testing, equipment evaluation for GLP/GMP environments, and international business development with a focus on regulatory affairs. Since 2020, she has been managing global engineering projects for KNAUER's LNP formulation product line, supporting pharmaceutical innovation and vaccine development.