Aseptic/cGMP designs for production are available.
Micropore's processes are designed to be scalable - from laboratory formulation testing to production tonnages. This enables meaningful laboratory data to be used to scale a process to production volumes.
The low shear and gentle conditions used during membrane emulsification are ideal to prevent damage to protein based therapies and other sensitive active ingredients.
We have expertise in working with companies seeking to replace some less attractive emulsifying agents, e.g. polyglycerol polyricinoleate (PGPR), with more environmentally desirable ones, that need lower shear, provide greater stability and good control during processing.
We provide a service to develop the best release profile for your ingredients and products; using our expertise in encapsulation and formulation technology based on our membrane emulsification processes.
The Micropore patented manufacturing techniques provide uniform droplets and particles and lead to 100% production success in the desired size range. There is no waste compared to conventional manufacturing techniques. Using Micropore technology results in significantly lower energy and waste disposal costs.
Reliability and Reproducibility:
Micropore’s technology enables highly reliable and reproducible production of batches of materials. Our techniques lead to no 'bad batches’ to be disposed of.
The Micropore systems are easy to control and do not require time consuming and costly specialist operator training.
Materials of construction:
Micropore production equipment is constructed from a minimum number of broad compatibility materials, to simplify validation. For example the standard AXF-1 is made from dual certified316/316L stainless steel with Virgin PTFE seals. Electropolished parts and industry standard hygienic fittings tailor the AXF for pharmaceutical industry use.
Micropore’s equipment can be fully enclosed to ensure environmental segregation and product isolation.
The system is easy to control and has a lower factory space requirement than conventional stirred tank technology.
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As traditional homogenisation techniques give a broad particle size distribution, when manufacturing microcapsules, this means that the payload in each microcapsule will be slightly different. In pharmaceutical applications, each capsules content must be known exactly to prevent, over or under-dosing of the drug.
The Solution and Benefits
Micropore’s patented membrane emulsification technology was used to produce the microspheres to be used in pioneering new drug delivery methods.
Our customer needed a high degree of control in order manage and measure the size of particles. This allowed the optimal size for a microsphere for this application to be found this is essential for the longer term in view of regulatory body requirements.
The speed with which the team could progress using Micropore’s technology was an important factor for the R&D team.
One of our customer commented: “We spent about 18 months on this project and made excellent progress in that time. In 12 months, we progressed from experimental to prototype and are now looking at preclinical trials. That’s an impressive time scale to achieve".
How we can help you
Micropore excels at evaluating complex challenges and finding creative, sustainable and scalable solutions.
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