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AXF Pathfinder

Micropore Technologies

The AXF-Pathfinder is a compact integrated benchtop unit that promises to reduce the cost and accelerate the development of nanoparticle formulations, including genomic medicines.
Manufacturer Micropore Technologies
Product Series AXF series
Application Emulsions, Liposome Processing & Mixing, Nanoparticle formulation
Sample type Nanomedicines, Microspheres, Polymer nanoparticles, Crystals, Liposomes, Nucleic acid lipid nanoparticles (LNPs)
Formulation Technology Advanced crossflow (AXF™) mixing
Particle size distribution Narrow (typical CV~10%)
Volumes formulated 0.2-250ml

The Micropore AXF-Pathfinder is a compact integrated benchtop system with a fully integrated and intuitive software platform to enable the clinical and commercial manufacturing of particles like genomic medicines. Based on Micropore’s well-established AXF mini crossflow mixing device, the system minimises waste both during start-up and during operation.

Generate high throughput formulation development samples using one of two modes: ‘Discover’ mode and ‘Develop’ mode.

  • Discover Mode – Identify broad operating conditions to produce desired particle size and PDI. Typical sample size can be around 200 μL.
  • Develop Mode – Enables larger samples for in-depth analysis and in vitro and in vivo studies.
  • Produce Mode – Individual samples size can be up to 125 mL or 250 mL depending on the model, or fully continuous production in the Horizon system.

Simple to set up and operate with no consumables, samples can be generated into a standard multi-well plate or a conical flask. A number of options extend capability including 21 CFR part 11 compliance.

Ease of scalability – one mixer from lab to clinic to GMP manufacture

LAB SCALE

Pathfinder PRO 125 (200 μL-125 ml) is designed for high throughput formulation development using an intuitive software platform to deliver DOE samples into a standard multi-well plate. It delivers from 200 μL per sample into a 24, 48 or 96-well plate and it will fill the 96-well plate in less than 1 minute. PRO 125 is formulation flexible and able to achieve encapsulation efficiency typically >98%.

CLINICAL SCALE

Pathfinder PRO 250 (200 μL-250 ml) increases the volume of samples produced to 250ml. It delivers higher volumes of production using the same operating conditions. The larger volume samples can be used for in-depth analysis of physical properties and in vitro and in vivo studies. Certified to GMP and 21CFR part 11. PRO 250 is formulation flexible and able to achieve encapsulation efficiency typically >98%.

GMP SCALE

Horizon LNP Mini enables formulations to seamlessly transfer from the Pathfinder series given the use of the identical AXF-Mini geometry. This sealed GMP system has a nominal flow rate range of 12 – 500 ml/min and is supplied with software tools for user management and data integrity inline with the regulations of 21 CFR Part 11. Pumping pressures are low compared with T-mixers, with excellent performance achievable at 2-3 barg.  This allows for a much wider choice of pump technologies, with less complex sealing arrangements, leading to reduced maintenance requirements and improved hygienic design.  Suitable pumps are available over a wide range of flowrates, therefore there is no need to number up pumps, and consequently there is a reduced maintenance burden.

For a given AXF configuration, LNP size can be controlled by changing total flowrate.  The resulting particles achieve PDI<0.2 and very high encapsulation efficiencies, typically >98% after optimisation.

AXF parts are all electropolished 316 stainless steel, with the only consumables being PTFE O-rings to seal the membrane, and sanitary flange gaskets.  Therefore, the AXF itself may be sterilised by steam or dry heat.

Resources

Continuous, scalable

  • Streams of mono-dispersed particles at controllable dimensions with a narrow particle size distribution (typical CV~10%)

Low maintenance

  • Low-cost operation,  with no moving parts, that are easy to clean
  • Small equipment footprint (able to fit into a small briefcase)
  •  SS316 & PTFE parts for high material compatibility and simple sterilisation

High Volume, GMP ready

  • Throughput volumes from discovery phase through to clinical and manufacturing (0.06L/hr-1500L/hr)

Efficient Cross Flow Mixing

  • Preservation of biological activity of biomolecules after encapsulation
  •  Up to 30% lower energy usage compared to other emulsion generation methods

Micropores membrane technology is ideal for creating complex formulations and to solve formulation challenges to deliver the highest performing, most efficient, cost-effective formulated delivery systems. Micropore’s patented crossflow membrane technology is used in applications including pharmaceuticals/ medicines, food/ nutrition, cosmetics/ skincare, household products, agrochemicals/ farming and construction.

Some of the most recent applications include:

  • Liposomes & Lipid nanoparticles (LNPs)

Liposomes and LNPs are amphiphilic structures used as drug delivery vehicles to encapsulate both hydrophilic and hydrophobic active pharmaceutical ingredients (APIs). LNPs have gained prominence recently due to their ability to deliver therapeutic payloads, including DNA and mRNA for vaccines, precisely through treating their surface with proteins allowing highly specific binding to a target cell type.

Publication: Production of mRNA lipid nanoparticles using advanced crossflow micromixing

Muattaz Hussain, Burcu Binici, Liam O’Connor, Yvonne Perrie, Production of mRNA lipid nanoparticles using advanced crossflow micromixing, Journal of Pharmacy and Pharmacology, Volume 76, Issue 12, December 2024, Pages 1572–1583, https://doi.org/10.1093/jpp/rgae122

 

  • Fragrance encapsulation

Fragrance chemicals can be found in laundry detergents, soaps and personal care products, however fragrances exhibit high volatility and rapidly lose their aroma or, worse, transform into unpleasant odours, if subject to prolonged atmospheric exposure. Microencapsulation of the fragrance material applies a protective coating. Micropore Encapsulation technologies can provide the repeatability, reproducibility and fine control not previously offered by historic emulsification techniques.

  • API Crystallisation

Crystallisation defines an APIs physical properties and ability to deliver the desired therapeutic effect and to avoid undesirable effect  Micropore’s robust continuous membrane technology can eliminate many of the issues faced by both batch cooled and anti-solvent approaches to crystallisation and is scalable to tonnes per hour.

  • Core-shell coacervation in drug delivery

Complex coacervation involves the microencapsulation of products where the core is surrounded by a shell (2 – 300 μm) which protects it against degradation while enabling control over payload delivery under specific conditions. Eg. Selective encapsulation of therapeutic nucleotides, such as miRNA mimics, small interfering RNAs, and transcripts to accommodate a wide range of therapeutic strategies including inhibition of atherogenic miR-33a in atherosclerosis.

  • Hydrogels in drug delivery & biomedical engineering

Hydrogels consist of tunable 3D, hydrophilic, polymeric networks that protect labile drugs from degradation and assist their controlled release. Currently, hydrogels are used for manufacturing contact lenses, hygiene products, wound dressings, tissue engineering scaffolds and drug delivery systems. Micropores’ Membrane emulsification overcomes many existing production challenges by forming hydrogel droplets directly as a w/o emulsion. Precise size control can be achieved with perfectly spherical droplets in sizes less than 50μm.

  • Sustained release PLGA microspheres

PLGA (Poly (lactic acid-co-glycolic acid)) is used for surgical implants and sutures because of its biodegradability, biocompatibility and sustained-release properties. However PLGA is not easy to formulate into sustained release drug products meaning inventor drug products and generic versions remain scarce with only 20 drugs approved in 30+ years. Micropore’s technology is an inherently gentle process that results in very high-quality microspheres when using a double emulsion process, because the primary emulsion is not broken during secondary emulsification. Micropore’s continuous manufacturing technology offers no risk in scaleup. No product degradation – Right size first time – Reduced compliance issues.

  • Silica particles

Mesoporous silica particles (MSP) have gained wide popularity over recent years because of their advantages of uniform and tunable pore size, easy independent functionalisation of the surface, internal and external pores and the gating mechanism of the pore opening make it a distinctive drug carrier. Their high loading capacity due to the large pore volume and surface engineering properties allows for better drug targeting. These versatile carriers can be used for loading a variety of cargos ranging from drugs to macromolecules such as proteins, DNA and RNA.

  • Phase Change Materials

Phase change materials (PCMs) allow the storage of large amounts of latent heat during phase transition. They have the potential to both increase the effciency of renewable energies such as solar power through storage of excess energy, and to reduce overall energy demand through passive thermal regulation. NASA has identified more than a hundred of these materials. In addition to passive energy storage, they have application in thermoregulated fabrics, high power electronics, telecommunication installations and microprocessors. PCMs are not suitable for use without prior encapsulation. Encapsulation in a shell material provides benefits including protection of the PCM from the external environment and increased specific surface area to improve heat transfer.

What is the Micropore Pathfinder used for? 

The Micropore AXF-Pathfinder is a compact, benchtop system used for the rapid, efficient, and scalable production of nanoparticles, particularly in the development of mRNA-based vaccines and RNA/LNP (lipid nanoparticle) therapeutics. It uses advanced crossflow mixing technology to create uniform, monodisperse particles, enabling seamless scaling from formulation development to commercial GMP manufacturing.

What is advanced crossflow mixing?

Advanced crossflow (AXF™) mixing is a precise, low-shear membrane technology used to create emulsions, suspensions, and lipid nanoparticles (LNPs) with extremely tight size distributions. By passing fluids across a precision-engineered membrane, it offers continuous, scalable, and contamination-free mixing for pharmaceutical, cosmetic, and food applications

How does crossflow technology work?

The Pathfinder uses Advanced Crossflow (AXF) mixing technology, which formulates nanoparticles through controlled fluid dynamics rather than traditional batch methods, enabling precise and reproducible nanoparticle production.

What are the advantages of the AXF Pathfinder?

The Micropore AXF Pathfinder is a compact, integrated benchtop system designed for the formulation and development of nanoparticles, specifically for Lipid Nanoparticle (LNP) therapeutics, mRNA vaccines, and drug delivery systems. It utilizes Micropore’s patented advanced crossflow (AXF) membrane technology, which offers significant advantages in efficiency, scalability, and cost over traditional mixing methods

What applications is the Pathfinder suitable for?

The Pathfinder is suitable for producing liposomes, lipid nanoparticles (LNPs), polymer nanoparticles, microspheres, and crystalline materials, primarily for genomic medicine and drug delivery applications.

What is the throughput capacity of the Pathfinder?

In high-throughput mode the Pathfinder can fill a 96-well plate in under 60 seconds. Sample volume range is 0.2 mL (Discover Mode) to 250 mL (Produce Mode) depending on the model. An aseptic unit containing multiple membranes can be customised for the required operating throughput up to 1500 L/hr.

Can the Pathfinder be used for genomic medicine production?

Yes. The Pathfinder is specifically designed to accelerate nanoparticle formulation development including genomic medicines. The Pathfinder PRO 250 is GMP certified, and the Horizon LNP Mini PRO production-scale system supports 21 CFR Part 11 compliance.

What sample volumes does the Pathfinder handle?

The Pathfinder handles sample volumes from 0.2 mL (Discover Mode) up to 250 mL (Produce Mode). Continuous production is available via the companion Horizon system.

How does the Pathfinder ensure reproducibility?

The Pathfinder achieves reproducibility through controlled AXF mixing, delivering narrow particle size distributions with a coefficient of variation of approximately 10% and encapsulation efficiency typically exceeding 98%.

What is the difference between Discover and Develop modes?

Discover Mode uses minimal sample volumes (~200 uL) to identify optimal processing conditions such as flow rate. Develop Mode produces larger quantities for comprehensive testing and preclinical studies.

Can the Pathfinder be scaled up for production?

Yes. The range includes three main models: Pathfinder PRO 125 (lab-scale), Pathfinder PRO 250 (clinical-scale with GMP certification), and the Horizon LNP Mini (production-scale with 21 CFR Part 11 compliance).

What types of nanoparticles can be produced with the Pathfinder?

The Pathfinder can produce liposomes, lipid nanoparticles (LNPs), polymer nanoparticles, microspheres, and crystalline materials.

Why is the Pathfinder important for nanoparticle formulation development?

The Pathfinder provides GMP-ready nanoparticle production from day one, helping researchers and companies scale from R&D to clinical manufacturing seamlessly without switching to a different technology platform. It has the capacity to use a formulation created on virtually any other platform to distinguish optimal scale up conditions.

How is the Pathfinder different from microfluidic approaches?

Unlike traditional microfluidic approaches such as Impingement Jet Mixing, the Pathfinder uses lower shear and vanishingly low pressure, crucial for maintaining the stability of delicate formulations like mRNA-LNPs. It uses a single, reusable, consistent technology throughout development, keeping production costs low without expensive consumables. Constructed from durable 316L stainless steel, it allows thorough industrial cleaning and sterilisation, making it ideal for GMP environments.

Who uses the Pathfinder?

Biotech companies, pharmaceutical developers, and academic labs focused on nanomedicine research use the Pathfinder for drug delivery, vaccine development, gene therapy, and other nanomedicine applications.

Can I have a demonstration or free trial of the Pathfinder?

Yes, if a system is available. Contact us for a booking. We can arrange a personalised demo and test your samples within our lab facility in Sydney. Onsite free trials are also available. Contact us or complete a request a demo form to get started.

Variant comparison

  Pathfinder 125 Pathfinder 250 Horizon systems
Product type Benchtop system for early-stage formulation discovery & screening Benchtop system for clinical development & scale-up Scalable automated production, Pilot-scale to GMP manufacturing
Formulation Technology Advanced Crossflow (AXF) mixing Advanced Crossflow (AXF) mixing Advanced Crossflow (AXF) mixing
Low-cost operation, with no cartridges, easy to clean, simple sterilisation
Volume range ~200 µL to 125 mL ~200 µL to 250 mL Continuous production from litres to manufacturing scale
Mixer geometry AXF-mini (lab)

AXF-1 (Manufacturing)

AXF-n (Large Scale Manufacturing)

AXF-mini (lab)

AXF-1 (Manufacturing)

AXF-n (Large Scale Manufacturing)

Same AXF geometry maintained across scale-up
Sample generation Multi-well plate compatible; Flask/vial production for larger studies Multi-well plate, Flask/vial production for larger studies Continuous inline manufacturing
Particle size distribution Narrow distribution, typically <0.2 PDI Narrow distribution, typically <0.2 PDI Highly reproducible monodisperse particles
Encapsulation efficiency Typically >98% Typically >98% Designed for reproducible high EE at scale
GMP suitablility Optional 21 CFR Part 11 compliance GMP & 21 CFR Part 11 ready Designed for GMP manufacturing
Ideal user Research labs, formulation scientists Translational research, biotech, clinical development labs CDMOs, pharma manufacturing, GMP facilities
Key advantages Fast, low-volume formulation optimisation Seamless transition to larger studies Scale-up without re-optimisation

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