TRANSFORMING ENCAPSULATION OF NUCLEIC ACIDS
DECENTRALISATION
EFFICIENCY
FLEXIBILITY
SUSTAINABILITY
Personalized medicine produced in minutes
Until now, manufacturing of therapeutic products requiring in-vitro or in-vivo transfection using genetic biomolecules has been very expensive and time-consuming. Emerging technologies show us how to do things never done before. They are largely unrealised and require transformation into solutions to maximize the use and benefit.
NANOme is our solution to lower these barriers and make personalized medicine more accessible.
NANOme is a disruptive technology providing a closed, disposable device for individualized patient manufacturing of encapsulated transfection material.
NANOme will be the first fully GMP-compliant lipid nanoparticle-encapsulation device enabling both centralized and de-centralized encapsulation.
NANOme is rapidly adaptable to clinical use of personalized medicines such therapeutic cancer vaccines and as an adjunct to platforms for CAR-T.
A new level of vaccine manufacturing
Fully automated aseptic device for next generation LNP-based genetic medicines encapsulation under GMP PAT enabling approach for process control and product release.
Flexible volume, fast and seamless scale-up of LNP from preclinical testing through to supply of GMP clinical trial material and ultimately commercial manufacturing, Robust, fast and cost-efficient.
A single NANOus system can produce 6-8 million vaccine doses per day, enabling exceptionally fast delivery of products to the market with a compact technical setup.
NANOus can be used for a broad range of delivery systems including lipid nanoparticles, liposomes and micelles. Integrated in-process controls enable time savings while retaining exceptionally high product quality. Set-up processes are accelerated, and validation only takes a few weeks instead of months.
Current processes of manufacturing vaccines can be taken to a new level by using our innovative aseptic cGMP technology.
SCALABILITY
EFFICIENCY
FLEXIBILITY
AGILITY
Discover LEON’s solutions of state-of-the-art nanoparticle production processes, and technology for scale-up and commercial manufacturing.
LEON´s device platform for encapsulation of transfection material
NANOnow is LEON’s proprietary nanotechnology platform that enables seamless process transfer – from preclinical scale for product and process development up to market supply.
As a part of LEON´s NANOnow product series we have developed two disruptive closed and aseptic working devices to realize the potential of our NANOnow product platform:
NANOus is our fully automated aseptic device for medium- to large-scale manufacturing of LNP-encapsulated APIs, such as mRNA vaccines. It is designed for GMP manufacture and allows real-time release of batches by PAT. NANOus is made for a high-volume and commercial production setting.
NANOme is the first fully GMP-compliant device, using single-use disposable kits to overcome the existing capacity bottleneck in personalised medicine and will also accelerate production of, e.g., CAR-T cell therapies.
SURFACE-STABILISED CTYSTALLINE NANOPARTICLES
POLYMERIC NANOPARTICLES
LIPOSOMES
SOLID-LIPID NANOPARTICLES
NANOEMULSIONS
MICELLES
With NANOsolv we expedite APIs, revitalize forgotten formulations and breathe new life into generics to deliver improved stability, increased solubility and enhanced bioavailability.
Our solution is based on our proprietary technology, a classic bottom-up approach to the synthesis of SMART nanoparticles or microparticles.
Our definition of SMART
Stable crystalline or polymeric particles
Measurable tailored size: 10 nm – 70 um
Achievable easy scale-up: bench to commercial
Relevant for all application forms
Timebound: fast continuous precipitation < 0.1 ms easily integrated into downstream processes
Our development pathway and equipment allow rapid prototype nano formulations and testing in pre-clinical models, with easy scale-up to support clinical and commercial availability. New formulations can be developed faster and the process can be validated easily enabling faster and more efficient clinical development. At LEON, we provide all the services needed to support Drug Product formulation delivery at nano scale, from initial concept through to product approval.
We work collaboratively with our pharmaceutical partners on a contract or co-development basis. The engagement process typically follows key stages.
