Evaluating downstream processing options at the bioprocess-business interface

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In recent years, therapeutic antibodies produced in recombinant mammalian cells have become the fastest growing part of the new biopharmaceuticals sector. Along with this growth there have been significant increases in titres during the cell culture, such that all companies now face great challenges in handling the resulting materials during downstream processing. This challenge combined with the major time pressures on bioprocess development means that the decisions now rest on a multitude of process and business issues and have become extremely complex. The cost of experimentation to explore all these options is prohibitive and hence modelling tools are vital for different process sequences and operating conditions to be examined inexpensively, thus saving time and reducing costly pilot/scale trials. The proposed programme will link the leadership in antibody production of CAT, the manufacturing expertise of AstraZeneca and the leadership in bioprocess decisional support systems of UCL to tackle some of these intricate process-business decisions. The resulting decision-support algorithms will identify the most cost-effective downstream manufacturing strategies for the future. This will be achieved by developing combinatorial optimisation techniques and integrating them with multi-objective decision analysis and detailed process economic and logistical models to allow for a holistic assessment of the interactions between operational and financial indicators for alternative purification strategies.