A research-based feasibilty study using a new manufacturing process to investigate production of specialist formulated particles in a cost-effective and high throughput process with highly defined particle properties. The innovative aim of the project is to use continuous membrane emsulsification as a means to formulate particles using physical as well as chemical formulation control, on a large enough scale to meet disclosed industry needs. Specialist particles have been shown to have unique properties for a number of commercial applications. The proposed research is preparatory to 'industrial research' which would build on the results from this initial feasibility study, investigating the behaviour of specific particle formulations in different commercial applications.

Microcapsules are ubiquitous in everyday life and are found in products used in crop protection, drug delivery, personal care, cosmetics etc. All microcapsules contain an active ingredient protected by the capsule shell for a multitude of purposes including safety, taste masking, stability and targeted delivery. To improve the performance of the capsule (in terms of stability and delivery behaviour) the capsule size distribution needs to be as narrow as possible, which is currently very difficult to achieve on industrial scales using existing manufacturing processes. Adapting microfiltration technologies to create membrane emulsification is a currently under-exploited manufacturing route that will enable the large-scale production of capsules with tightly controlled size distributions, leading to products with improved release properties at a cost that industry can afford. The technology will be tested on a specific high-value coatings application. The project is led by a small dynamic company, escubed limited who will work closely with researchers at the University of Leeds to develop the membrane technology for industrial use and will demonstrate its applicability to pilot plant scale at International Paint, a global leader in coatings technologies.

This project aims to transform a batch process for the manufacture of controlled release injectable drugs into a continuous process with appropriate control mechanisms to ensure robust, consistent product using methods that comply with FDA and other regulators' requirements. This has never been achieved before. It is particularly important for patient care and their treatments that sustained release drug therapies deliver their active components at a controlled and predictable release rate. Achieving this precise control of drug microspheres requires good control over particle size and size distribution during the manufacturing process. Micropore will partner with G2GBIO INC of South Korea in the project. The two companies have a history of collaboration since 2019\. During this time G2G BIO has repurposed an existing Alzheimer's drug as a long acting injectable to improve patient compliance. Micropore has supported G2GBIO with its advanced crossflow technology. G2GBIO has achieved Phase 1 clinical trial approval in Canada for their product. The next step in development is to convert the manufacturing process into a high volume continuous process that will pass regulatory scrutiny. Historically, it has been difficult to achieve economies of scale in the emulsification production supply chain. Standard manufacturing technology uses brute force rotor/stator homogenisation techniques, which provide localised high shear forces, damaging product quality, and resulting in a broad emulsion droplet size distribution. This requires costly separation processes to produce a narrower size range final product and creates significant wastage (Typically 30%+ but Micropore has a few examples of up to 90% wastage) of out-of-specification material. More recently Micropore's technology has demonstrated a near-zero waste capability arising from its gentle process technology. In this 3 year Micropore Technologies and G2GBio propose to scale up Micropore's crossflow technology from a single-membrane unit to multiple-membrane units to provide a significantly more cost-effective robust manufacturing route, meeting G2GBio's known requirements for multi-kilogramme manufacturing. In addition to this Micropore and G2GBio will collaborate to identify inline process analytics to enable the principles of the FDA, and other regulators, of Quality by Design (QbD) and Process Analytical Technology (PAT) to deliver an integrated process with robust process control. Micropore has won a number of global awards for its core technology and has gained market traction across the world.

Abstracts are not currently available in GtR for all funded research. This is normally because the abstract was not required at the time of proposal submission, but may be because it included sensitive information such as personal details.

In the production of pharmaceutical and fine chemicals, most of the reactions are conducted 'homogeneously' in one phase, i.e. a suitable solvent is used to dissolved all of the starting material, reagent and catalyst. At the end of the reaction, extra operations (known as 'work up') are required to separate the product from byproducts and any remaining starting materials. Work up/separation procedures can be complicated and time-consuming, and can constitute 40-70% of the costs of chemical processes. It also consumes extra resources (energy, material, additional solvent), which is detrimental to the environment. One way of overcoming the separation issue is to conduct multiphase reactions, where the starting material and the reagent are dissolved in immiscible solvents (such as oil and water). After the reaction, the products remain physically separated from the reagent and byproducts, which simplifies the workup procedure. However, there are several fundamental issues that need to be addresse; namely, how fast reactions can occur at the interface, and how to control it precisely to afford reproducible and predictable outcomes (which is very important for its eventual application in industry). The proposed programme will develop a new type of continuous manufacturing process for multiphase oxidations. First, it will use electrochemistry to generate inorganic oxidants in water from non-hazardous inorganic salts and electricity. The solution of oxidant will be mixed with reactants in an immiscible solvent, using a specially designed reactor that generates an emulsion from the two immiscible fluids. After the reaction, the two different phases then separate out naturally, thus simplifying the workup procedure. The research programme will focus on the generation of different oxidants and their intrinsic reactivity. We will also develop novel emulsion forming systems to handle liquid/liquid reactive flows. The rates of the various steps in the process will be deteremined, to produce a predictive model that we can be used to construct a mini-plant for demonstration purposes.