Moving complex emulsions from the laboratory to commercial production can be challenging. Processes that work well at small scale can behave very differently as volumes increase, leading to inconsistent particle sizes, product degradation, material waste and costly re-optimisation. In the pharmaceutical and specialty chemical industries, complex emulsions – such as water-in-oil-in-water (W/O/W) double emulsions, microspheres, and encapsulated fragrances – are notoriously difficult to move from the laboratory to commercial production. While a formulation may perform perfectly at a 50mL scale, increasing that volume often necessitates manufacturing trade-offs that compromise product integrity, triggering lengthy re-optimisation processes to resolve.
Some of the key challenges include:
1. Uneven energy distribution:
Traditional high-shear mixing can expose different parts of a batch to very different levels of energy, resulting in inconsistent droplet sizes.
2. Batch failure and material waste:
Over- or under-processing can compromise sensitive emulsions, potentially resulting in an entire production batch being rejected.
3. Constant process re-optimisation:
Conventional scale-up often requires mixing conditions to be re-tuned at each production volume, adding time and complexity.
4. Product degradation:
High shear and localised heat can damage sensitive components such as proteins, volatile oils and fragrances.
5. Operational variability during technology transfer
Processes that rely on manual adjustments during the R&D stage are difficult to replicate at an industrial scale.
Micropore Technologies’ AXF® technology offers more consistent approach and helps develop more controlled, reproducible and scalable nanoparticle formulations.
Low-shear advanced crossflow (AXF) mixing provides a different approach to scale-up. By creating droplets under controlled, consistent conditions, the same particle-engineering principles established during R&D can be maintained as production volumes increase. Continuous processing can also allow scale-up by extending processing time rather than fundamentally changing the mixing conditions. For manufacturers working with complex emulsions, microspheres and encapsulated products, choosing a scalable process early can help reduce waste, minimise re-optimisation and improve technology transfer from lab to production.
The AXF Pathfinder provides a flexible laboratory-scale platform for investigating formulation parameters, optimising processes and generating robust data before moving towards larger-scale production. Unlike conventional batch approaches, AXF uses controlled crossflow mixing to provide precise control over the mixing environment, helping researchers understand how process conditions influence particle size, distribution and formulation performance. Importantly, the Pathfinder is designed with scale-up in mind. Formulation conditions established at laboratory scale can provide a more reliable foundation for transferring processes to larger Horizon AXF systems, reducing the need to completely redevelop the process as production volumes increase. This makes AXF particularly valuable for researchers working towards larger-scale development, process intensification and GMP manufacturing.
To help you explore the technology, we have two comprehensive resources available for download:
Click here – AXF Pathfinder Handbook – A more detailed practical guide covering formulation development, process optimisation, scale-up considerations and the use of AXF for different applications.
Click here – AXF Pathfinder eBook – An introduction to AXF technology, its advantages and applications in nanoparticle formulation.
Download the Handbook and eBook to discover how AXF can support your journey from early formulation development through to scalable manufacturing.
Ask us for a demonstration today!