Process defining and simulation and scheduling of a standard vaccine for a modular concept

Process defining and simulation and scheduling of a standard vaccine for a modular concept is the title of a bachelor thesis created in the autumn semester 2011 in cooperation with NNE Pharmaplan A/S and Bioprocess Technology at Engineering College Aarhus.

The goal of the project was to define process modules, and to create a base case simulation and scheduling, for the modular vaccine facility concept. The results showed that nine process modules were sufficient. The modules were divided on three upstream -, two fermentation/cultivation and four downstream modules. The modules were created by comparing five different standard vaccines, each using a different technology. For each vaccine candidate some customization of each module should be expected.    

For a standard inactivated vaccine was the manufacturing process simulated by using Intellegin SuperPro Designer. Though the simulation was each unit operation sized and the consumption of buffers and cultivation medias defined. The standard inactivated vaccine was scheduled by using Intellegin SchedulePro. Besides a production schedule did the scheduling also include a scheduling of the buffer and media preparation. The result of the simulation and scheduling was that the desired flexibility was not obtained, but if a vaccine candidate for the modular concept uses the same technology and has approximately the same process design could the simulation and scheduling give indication of the process.      

The data generation from SuperPro Designer and SchedulePro was optimized into company standard by including Microsoft Excel and Visual Basic for Application. The AddIn optimized the time of creating Microsoft Excel repots and minimized the risk of losing data.

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