Micropore AXF Pathfinder

The AXF-Pathfinder is a compact integrated benchtop unit that promises to reduce the cost and accelerate the development of genomic medicines.

Micropore AXF Pathfinder

The AXF-Pathfinder is a compact integrated benchtop unit that promises to reduce the cost and accelerate the development of 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 TechnologyAdvanced crossflow (AXF™) mixing
Particle size distributionNarrow (typical CV~10%)
Volumes formulated0.2-250ml

Product Overview

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.

  • Demonstration video
  • Benefits
  • Applications

Demonstration video

Benefits

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

Applications

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:

  • 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.

  • 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.

  • 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.

Product Enquiry

SPEAK TO OUR AUSTRALIAN AND NEW ZEALAND TEAM

If you would like to enquire about this product, fill out this form and one of our product specialists will contact you shortly.
If you need help in the operation or repair of an instrument then please contact the Customer Help Centre directly.

Please note, product enquiries are only applicable to Australia, New Zealand, Papua New Guinea and Fiji


    Or call us instead at (02) 9541 3500