Discover the best formulation, fast. Start with the right technology and scale with confidence NANOscreen® is a user-friendly system designed for rapid formulation screening and identification of an early-stage product formulation with minimal material losses. The NANOscreen®, augmented by the FR-JET® mixing technology, in combination with our intuitive user interface, enables precise control over all relevant process parameters. Key Benefits Rapid screening and formulation identification Methods directly transferable to NANOlab® - no redevelopment required Flow rates <100 mL/min Batch sizes as small as 0.5 mL Minimal material losses Automated waste/sample separation Fully automated cleaning cycle User-configurable process parameters User-defined internal formulation library Application Discovery, formulation screening, early development Dimensions*approx. 40 cm x 50 cm x 40 cm Total flow rate up to 100 mL/min Sample size 0.5 - 12 mL (FRR = 3:1); 0.5 - 20 mL (FRR = 1:1) No. of inlets 2 (3rd channel for ILD available) Automation single sample mode (screening functionality coming soon) Mixing technology FR-JET® (re-useable stainless steel or extended single-use polymer) GMP capability No *All dimensions are width x depth x height
The NANOme® is a single-use, cassette-based manufacturing system purpose-built for GMP-compliant decentralized and PoC manufacturing. Designed as a benchtop, fully closed system, it uses a pre-assembled cassette that is gamma sterilized and enclosed in triple-layer sterile packaging to ensure integrity and ease of integration. It supports both individualized batch sizes (n=1) and high-throughput vaccine production, within a compact and closed design suitable for hospital pharmacies, regional hubs, or modular GMP suites. Key features: - Production of sterile batches (50–1200 mL) in 10–20 minutes - Pumpless system eliminating risk of shear-stress and degradation of materials - Operated using 21 CFR Part 11 GMP-compliant software - No cleaning or cleaning validation required between batches - Process controlled by predefined, validated input parameters The system accelerates production timelines and reduces operational complexity, making it well suited to the unique needs of ATMPs and mRNA-based therapies. Table 1. Current challenges for manufacturing of small GMP batches of nanoparticle-based products. Operational: Small batch size & fast turnaround needed - Enables rapid encapsulation of mRNA in sterile batches (50–1200 mL) in 10–20 minutes, ideal for personalized therapy timelines. Frequent changeovers & cleaning validation - Uses pre-assembled, single-use cassettes eliminating cleaning and cleaning validation, and reducing downtime and cross-contamination risk in the encapsulation step. Decentralized or PoC production requirements - Compact, benchtop system supports GMP-compliant encapsulation at hospital pharmacies, modular suites, or regional hubs, enabling proximity to patients. Technological usability: Difficulty in miniaturizing encapsulation technologies - Provides closed, miniaturized GMP-compliant mRNA encapsulation, eliminating the need for large, customized LNP systems. Reproducibility in LNP formulation - Encapsulation is controlled via validated, predefined input parameters, improving batch-to-batch consistency even at n=1 scale. Sterility assurance during encapsulation - Fully closed and sterile design with gamma-sterilized cassettes ensures aseptic processing without cleanroom fill-finish dependencies for this step. Cost-related: High cost due to manual or large-scale systems - Reduces cost by eliminating the need for cleaning, minimizing facility and equipment overhead, and streamlining encapsulation at point-of-need. Labor-intensive and error-prone manual steps - Operated via GMP-compliant software, reducing human intervention, training burden, and error rates during encapsulation. Regulatory: Complex validation of encapsulation step - Predefined, validated parameters enable easier regulatory filing and batch release for encapsulation-specific operations. Facility compliance hurdles - Closed system reduces environmental requirements, easing GMP facility design for encapsulation in decentralized settings. Data & Integration: Traceability and documentation gaps - Controlled by 21 CFR Part 11 GMP-compliant software, ensuring traceable, auditable encapsulation records suitable for regulatory submission. The NANOme® system presents an opportunity to align manufacturing innovation with emerging regulatory frameworks. Its design supports practical implementation of decentralized GMP production models and provides a real-world basis for exploring: - Parametric release models for nanoparticle-based medicinal products - GMP aseptic processing for point-of-care and modular manufacturing facilities - Broader acceptance of processes utilizing single-use and closed-systems - Harmonization of regulatory pathways across EU member states for individualized therapies The NANOme® system represents a breakthrough in the encapsulation of mRNA for personalized and small-batch therapies by combining speed, sterility, and GMP compliance in a compact, closed format. Its single-use, cassette-based design eliminates the need for cleaning and validation, significantly reducing operational complexity and turnaround time. By enabling decentralized, reproducible LNP formulation, the NANOme® makes individualized mRNA and gene-editing therapies more feasible, scalable, and accessible.
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FR-JET® delivers true jet-impingement mixing and features a modular design with interchangeable parts to enable seamless scaling. Our innovative approach allows for fine-tuning of process parameters through our intuitive software, delivering optimal product formulations from early-stage development through to large-scale production. The Underlying Principle Jet impingement mixing involves the rapid mixing of two high-velocity liquids to generate a highly turbulent yet stable mixing process, in which liquids mix for a very short period of time within the mixing chamber. The unique spherical internal geometry of our mixer maximizes turbulent mixing efficiency through minimizing the surface area-to-volume ratio which eliminates dead volumes and generates highly uniform nanoparticles. Watch impingement mixing happen inside the FR-JET®. Within the spherical core of the FR-JET®, two high-velocity fluid jets impinge and form a highly turbulent flow regime that allows highly efficient mixing of the starting material solutions. To control mixing intensity across scales and to account for various flow rate ratios, the spherical core and pinholes that shape the jets are variable in size – allowing precise control of the hydrodynamic fingerprint of the FR-JET® mixer. Liquid A · Water 22.5 mL/min Liquid B · Ethanol 7.5 mL/min Mixing core 3 mm Pinholes 300/150 µm Peak velocity 9.07 m/s Peak TKE 6.06 m²/s² What sets FR-JET® apart is the modular architecture - Interchangeable cores and pinhole inlets: Interchangeable cores and variable pinhole sizes allow tuning the mixing process and support a broad range of flow rates without sacrificing mixing quality. - Predictive process design: Relates process parameters to particle attributes including particle size, polydispersity index, and encapsulation efficiency. - Versatile: Compatible with a wide range of nanoparticle formulations and diverse payloads: lipid, liposome, polymer, nanocrystal, mRNA, siRNA, saRNA, circRNA, pDNA, small molecules. - Improved Particles: High percentage uniform solid-core nanoparticles. Enhanced biological activity compared to conventional mixers. - Reliable and Robust: Broad chemical compatibility. Tolerates high viscosity. Minimizes clogging.
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Benchtop system for process development and non-clinical studies. Start with the right technology and scale with confidence Product Overview Seamlessly transition your initial formulation from NANOscreen® to NANOlab®. The NANOlab® delivers batch sizes as small as 1 mL all the way through to continuous operation. With flow rates ranging from 6-500 mL/min, enabled through precise control of our patented FR-JET® mixing technology, hitting your target nanoparticle specifications for every batch is easy. The process parameters identified using our NANOlab® system can be directly scaled to our GMP-ready NANOme® or NANOus® systems, without the need for intermediate steps or additional equipment. Supports all non-clinical development studies. Key Benefits - Methods directly transferable to GMP systems NANOme® or NANOus® - Flow rates 6-500 mL/min - Batch sizes from 1 mL - Precisely regulated flow rate with internal flow sensors - In-line dilution (coming soon) - Flexible sampling mechanism: 15 or 50 mL sample tubes and continuous mode for larger batch sizes - Internal, user-configurable process library An example process development workflow with the NANOlab® system. Application: Process development & non-GMP manufacturing Dimensions: approx. 45 cm x 60 cm x 45 cm Total flow rate: 6 – 500 mL/min Batch size: No upper limit (continuous) No. of inlets: 2 (3rd channel for ILD available) Mixing technology: FR-JET® (re-useable stainless steel or extended single-use polymer) Process mode: Batch & continuous GMP capability: Non-GMP All dimensions are width x depth x height NANOlab® System Tech Sheet NANOlab® TFRs Tech Sheet
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Continuous manufacturing mode for large-scale GMP production. Start with the right technology and scale with confidence Product Overview NANOus® represents the future of commercial-scale GMP manufacturing. With continuous operation and a flow rate up to 1200 mL/min, NANOus® removes the need for parallelization of production lines, significantly lowering operating costs for CDMOs and large pharmaceutical companies. NANOus® features a highly configurable closed system with features like process analytical technology (PAT) and cleaning and sterilization in place (CIP/SIP) to ensure every batch delivers the highest quality. Key Benefits Continuous manufacturing customized to your process for reliable commercial production One step scale-up from NANOlab® Designed for Grade C aseptic manufacturing Removes the need for parallelization on manufacturing lines Continuous operation mode Flow rates up to 1200 mL/min Application Commercial-scale GMP production Dimensionsapprox. 2.4 m x 1.0 m x 2.2 m Total flow rate<1200 mL/min Batch size No upper limit (continuous) No. of inlets 2 (3rd channel for ILD available) Mixing technology FR-JET® modular mixer Process mode Continuous GMP capability Full GMP, cleanroom-compatible Integration In-line dilution, TFF, sterile filtration All dimensions are width x depth x height The NANOus® was developed in partnership with Harro Höfliger, a leading provider of technology solutions for pharmaceutical manufacturing, including aseptic processes.
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