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Development Portfolio: Semi-Continuous Manufacturing

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In collaboration with a key strategic customer, Aesica has brought to market readiness a product
manufactured using the first semi-continuous processing line and technology installed at a CDMO. The line delivers continuous flow, from the wet granulation stage, through to tablet compression.

Unlike the more traditional batch based methods used for tablet manufacture, which take days with
this process, after initial blending, the production of uncoated tablets is carried out in 40 minutes. Aesica can offer semi-continuous manufacturing capacity to other customers and provides this service from its Queenborough, UK finished dose manufacturing facility.

Semi-continuous manufacturing meets the market demand for shortened drug development
times, a reduction in the quantity of API required in development, and a reduction in clean down
and batch transfer loss during the manufacturing process. In addition, it enables process development, clinical scale manufacture and commercial manufacture to be carried out on
the same piece of equipment. This results in rapid collection of data to demonstrate the robustness and quality of the manufacturing process using QbD (Quality by Design) principles.

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