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.