Our facility in Gateshead holds a UK MHRA Manufacturing Licence [UK GMP 22280] for the manufacture of APIs, raw materials and IMPs, using Microfluidising [wet] or ball milling [wet or dry]. Our license includes chemical/physical particle sizing analysis. We have an extensive range of particle characterisation equipment including the most advanced digital imaging technologies. This enables us to quickly optimize the production methods, and also enables us to perform method development and method validation services in accordance with ICH guidelines. We have considerable experience in developing suitable surfactant /dispersant systems to optimize stability and particle size reduction in, for example, dispersions, emulsions and liposomes. Where appropriate we use freeze drying at both lab and pilot scale under cGMP retaining particle characteristics.
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