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.
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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.
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.
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.
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.
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.
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 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.
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) | ✓ | ✓ |
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.
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.
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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