The pharmaceutical development of nanoparticle-based products, which encapsulate small molecules or large biomolecules, is a complex operation that has been met with various hurdles. From designing stable formulations to the critical task of scaling up to GMP-compliant manufacturing processes requires a holistic solution that can be relied upon. Current conventional technologies, fall short in addressing critical challenges in mitigating the risk of aseptic manufacturing, suboptimal product CQAs, high batch-to-batch variability, and steep production costs.
Recognizing the complexity of the emerging drug modalities, LEON has introduced the FR-JET® technology.
THE FR-JET® MODULAR MIXER
The FR-JET® Technology is based on jet-impinging principles and features a modular design with interchangeable parts. This innovative approach provides the flexibility to fine-tune process parameters from the early development stages through to large-scale production.
THE UNDERLYING PRINCIPLE
Two liquids are injected into the mixing chamber under pressure through two nozzles. This process establishes a highly turbulent yet stable mixing process, in which the liquids mix in a very short period of time within the mixing chamber.
The unique internal geometry of our mixer core maximizes turbulent mixing efficiency by minimizing the surface area-to-volume ratio and reduces deviations from ideal reactors by eliminating stagnant or dead volumes.
UNIQUE PROPRIETARY MIXER GEOMETRY, FEATURING A SPHERICAL CHAMBER AND MODULAR INSERTS
VERSATILE
- Wide variety of nanoparticles (lipid nanoparticles, liposomes, polymeric nanoparticles, nanocrystals, etc)
- Enables encapsulation of diverse payloads (mRNA, siRNA, saRNA, circRNA, pDNA, small molecules…)
- Allows processing at high starting materials concentrations (lipids and RNA)
SAME FORMULATION - BETTER PARTICLES
- FR-JET® modular mixer produces a higher percentage of uniform solid-core nanoparticles
- Same formulation manufactured with FR-JET® modular mixer shows enhanced biological activity compared to conventional mixers
BROAD DESIGN SPACE & EASY SCALE-UP
- Performs at both very low and very high flow rates and across a wide range of flow rate ratios
- Robust and simple scale-up with predictive mathematical tools
- Simple 1-step process transfer to GMP systems
RELIABLE & ROBUST
- Broad chemical compatibility of the FR-JET® stainless-steel and polymer mixer
- Handles high-viscosity starting materials
- Prevents material build-up and minimizes risk of clogging