Micropore Pathfinder

One mixer from lab to clinic to GMP manufacture

Nanoparticle engineering using a single, reusable device overcomes the limitations of existing methods of LNP manufacture and offers a single approach to address all the stages in the process.

Book a free trial of the Micropore AXF Pathfinder, the innovative solution for overcoming challenges in LNP manufacturing. Our expert team will visit your premises to demonstrate how this compact device can deliver optimal, scaleable results.

Micropore AXF Pathfinder LNP mixing device
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Micropore Pathfinder mixing device

Democratise Medicine - Micropore Pathfinder

Micropore advanced cross flow mixing technology enables a faster, cheaper and more efficient LNP manufacturing process. The mixing device is small enough to fit in the palm of your hand, can disassemble completely and is simple to clean.

It can be scaled up in volume from 0.2ml used during development stages to 20L/hr and beyond as required. It uses the same shear, same physics and same technology from lab bench to manufacturing scale to enable scale up with confidence.

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You may be experiencing a formulation challenge, require support, or would like a feasibility study. Let's discuss your research requirements.

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The product development journey
The journey

The product development journey all starts with mixing

Product develop is a journey and has distinct phases that can include discovery, pre-clinical, clinical and manufacturing. The formulation technology you start with affects the whole development journey.

Discovery

Pre-clinical

Clinical

Manufacturing

Microfluidics mixing technology
Manufacturing process

Current mixing technologies present challenges

When considering the manufacturing process of an LNP it is important to understand the speed of production, robustness of the technique, in process controls needed and the yield that can be achieved.

Impingement jet mixing (IJM) or T-mixers are the most widespread manufacturing method currently. It involves rapid high turbulent mixing and can support high yields through batch mode by placing units in parallel configuration with synchronised pumps. Although IJM is popular for many pharmaceutical manufacturers, concerns remain, high turbulent mixing combined with high pressure and shear stress effects can compromise LNP stability and affect overall performance of the product.

T-mixers and microfluidic chips

Microfluidics is another popular method that offers high reproducibility and can be used for formulation at the discovery stage but each microfluidic chip has a very limited throughput. You can use a number of microfluidic chips in parallel but unlike computer chips there are practical limits to fluid channel miniaturisation, and they require complex set ups.

So, it's just not possible to scale up formulating using microfluidics and as your development journey continues you will always reach a no through road for microfluidic technology.

CREATE

Overcome roadblocks experienced by other methods. Discover Micropore advanced cross flow technology, how it works and benefits or capabilities it provides.

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Pathfinder AXF family
Advanced Cross flow (AXF)

Starting small: Pathfinder AXF family

Using a stainless-steel, 316L precision engineered membrane, Micropore advanced cross flow mixing technology enables a faster, cheaper and more efficient LNP manufacturing process. The mixing device is small enough to fit in the palm of your hand, can disassemble completely, is simple to clean and requires PTFE O-rings a simple, low cost consumable.

Advanced Cross flow (AXF) and microfluidic mixing both offer similar levels of experimental control and performance at the discovery stage where the formulation quantities can be as small as 1-2 mL. As development continues to the pre-clinical stage the output of an AXF mixing device with 100,000 pores can easily be increased to deliver from 1-2 mL up to 10-20 L/hr and beyond to 100s of mL as required.

Zetasizer size distribution report of LNPs created with the Micropore AXF mini

  • Continuous, scalableNarrow particle size distribution
  • Low maintenance, no cartridgesNo moving parts, that are easy to clean. Small equipment footprint
  • High volume, GMP readyDiscovery through to clinical and manufacturing (0.06L/hr - 1500L/hr)
  • Efficient cross flow mixingmRNA encapsulation efficiencies over 97% in LNP production
Results:
Z-Average (d.nm):54.82
Intercept:0.949
PdI:0.060
Result quality:Good
LNP size distribution report
Micropore AXF technology

DELIVER

Chat to us about how throughput Micro and Nanoparticle engineering is achieved with a single Micropore platform using scalable membrane emulsification and encapsulation technology.

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Ease of scalability

Micropore advanced cross flow mixing technology enables a faster, cheaper and more efficient LNP manufacturing process. The mixing device is small enough to fit in the palm of your hand, can disassemble completely and is simple to clean.

It can be scaled up in volume from 0.2ml used during development stages to 20L/hr and beyond as required. It uses the same shear, same physics and same technology from lab bench to manufacturing scale to enable scale up with confidence.

Micropore advanced cross flow mixing technology enables a faster, cheaper and more efficient LNP manufacturing process. The mixing device is small enough to fit in the palm of your hand, can disassemble completely and is simple to clean.

It can be scaled up in volume from 0.2ml used during development stages to 20L/hr and beyond as required. It uses the same shear, same physics and same technology from lab bench to manufacturing scale to enable scale up with confidence.

Micropore technologies continuous formation
Micropore technologies

Continuous Formation & Stabilisation of LNPs Increases Scale, Reduces Hold Time & Minimises Risk of mRNA Degradation

Micropore technologies employs laminar flow mixing across a permanent stainless steel membrane to produce reproducible, scalable LNPs. The outer dispersed phase is continuously mixed with the aqueous inner compartment to form LNPs. Size controlled uniform particles are generated in a continuous flow capacity of up to 1500 L/hour making this by far the fastest production rate in the LNP industry. This would translate to roughly 58,000 doses of vaccine every minute, an important capability when faced with the demands of global disease emergencies.

Micropore LNP production diagram
Quality, efficacy and safety
Quality, Efficacy and Safety

GMP compliance with online and inline analytical tools

Key elements every regulator will consider when deciding whether to approve a LNP vaccine or therapeutic are Quality, Efficacy and Safety. Critical Quality Attributes (CQAs) when developing LNPs include: particle size, polydispersity, zeta potential, RNA loading.

ATA Scientific offers several technologies to characterise LNPs. These can be found in the table below.

Advanced Physicochemical Analysis Solutions

ATA Scientific technology Particle size Polydispersity Particle concentration Surface charge Thermal stability Higher order structure Binding interaction Particle composition
Dynamic Light Scattering
Inline/online DLS
Multi Angle DLS (MADLS)
Nanoparticle Tracking Analysis (NTA)
Electrophoretic Light Scattering (ELS)
Laser Diffraction
Differential Scanning Calorimetry (DSC)
Isothermal Titration Calorimetry (ITC)
Grating Coupled Interferometry (GCI)
Microfluidic Modulation Spectroscopy (MMS)

Removing barriers for next generation LNP manufacturing

Micropore is a technology provider with global experience in manufacturing all different types of vaccine modalities can further ensure a cost-effective, high-quality process. Partnering with Micropore will enable a stronger benchmark with in-depth expertise and the ability to leverage novel technologies will also help reduce risk and shorten timelines.
With mRNA vaccine production requiring relatively less space than other approaches, new facilities may be more feasible and affordable. Micropore technology can enable localised production of vaccines and thus accelerate access to a much larger population. In locations with limited or no infrastructure, the Micropore approach can be the shortest route to production and can reflect the exact needs of the organisation at minimal cost.
Micropore offers a minimal cost model achieved through the AXF advanced cross flow technology platform. The flexibility of mRNA-based vaccines when manufactured using this single piece of stainless steel equipment with no consumables means it requires the least capital investment. The scalability of production (from 200 µL to 1500 L/hr) reduces the facility design complexity and means that more doses can be manufactured in a continuous process which eliminates variability, compared to a batch-to-batch approach. As such, this vaccine modality combined with the Micropore mixing platform can be a robust starting point for production with low risk.
Micropore cross flow technology demonstrates predicable scalability which is favourable especially for GMP manufacturing which means process controls can be introduced that are automated, process analytical technologies (PAT). Automated analysis of properties such as online particle size enables the option to automatically control any deviations in size and feed that back to control the pumps and optimise control to give the correct size again. This increases confidence in quality of production meaning throughput can be increased further.
The determinants of stability of mRNA in LNP formulations - what parts are predicated on the payload of mRNA and what portions are predicated on the lipid nanoparticles themselves or what portions are predicated on the development technology that's used - can be related to its size and its secondary structure. Messenger RNA poses a unique manufacturing challenge because of its large size. Other RNA entities such as siRNA and guide RNA for clustered regularly interspaced short palindromic repeats (CRISPR) technology typically are produced using chemical synthesis, which can be performed in a relatively controlled environment. But mRNAs are larger, with complex three dimensional structures that aren't yet fully understood.

Malvern Zetasizer (DLS) enables particle size and stability measurements while the RedShiftBio Aurora (MMS) system enables secondary structure (HOS) determination.

RESOURCES

A better way to create nanoparticles whitepaper

A better way to create nanoparticles

The landscape of Nanoparticle generation is changing rapidly. Interestingly most commercial offerings are not particularly novel, some are blatant 'me-too's' and frankly most struggle with scale. To understand the future a dive into history helps.

Let's discuss several modalities of nanoparticle generation such as T-tube mixers, microfluidics, confined injection mixers, and advanced cross flow technologies to understand why they work or not.

Access Free Whitepaper

Essential Guide to Nanoparticle Engineering eBook

Essential Guide to Nanoparticle Engineering for Drug Delivery - eBook

Unlock the full potential of your nanoparticle drug delivery systems with our comprehensive eBook. This essential guide delves into the intricacies of LNP manufacturing, offering expert tips on optimizing formulations, ensuring reproducibility, and overcoming common challenges.

Whether you are a researcher or a biopharma professional, you'll gain valuable insights into the latest technologies and best practices to streamline your LNP production from research to commercial scale.

Learn about the strengths and weaknesses of popular nanoparticle production processes, and discover what an ideal platform for nanoparticle production looks like. With practical guidance from industry experts, this resource is designed to help you achieve high-quality, scalable results in your nanoparticle engineering endeavors.

Download our Free eBook

Get in touch

Get in touch with ATA Scientific today to learn more about our systems and services and discuss how the Micropore Pathfinder can deliver nanoparticles at scale without extensive setup or cost. Trial options are available.

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