FAstLyo: Formulation accelerated freeze-drying by reduced vapour flow resistance (micro-collapse)

Abstract

"New medicines/therapies being developed by the pharmaceutical industry and research organizations are increasingly based on some type of biological (rather than chemical) substance, e.g. a large molecule like a protein rather than a small molecule like aspirin. These substances, known collectively as biopharmaceuticals, are significantly more complex to develop and manufacture as a stable and efficacious product than their chemical counter-parts. This increases the demand for new knowledge and understanding to enable the development of these products (for example the composition or formulation of the product) and the associated commercial manufacturing process. Progress in developing new methods and instrumentation which are tailored specifically to the concurrent design of product and process, has been constrained largely by the relatively small market for such instruments and the significant investment that is required to, first test their feasibility, and then develop into a fully validated market offering.

The aim of this project is to test the feasibility for developing a new instrument, that has the potential for further development into a high throughput screening tool that will provide the new knowledge required to accelerate and de-risk the development of new product in the fast developing markets for biopharmaceutical, while presenting a unique opportunity for SMEs in the CRO sector and Research Organizations to increase market share and create opportunities for high-skilled employment in this sector."

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