Seeding and Continuous Biopharmaceutical Crystallisation (SCoBiC)

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Biotechnology has made significant advancements in the understanding of human genomics and proteomics revolutionising medical diagnosis, prevention and treatment. Advances and breakthroughs in target-oriented biotechnology research have been used to enhance the synthesis of a number of commercially significant products. It has been reported that there are over 6000 biopharmaceuticals currently in development, potentially worth in excess of $100's bn (£145bn in 2012). Despite the increasing successes in discovering protein-based medicines, their manufacture in a cost effective and reliable fashion remains a major industrial challenge, which currently limits the ability of the biopharmaceutical industry to deliver solutions to patients. The vision here is to develop a programme for process intensification and de-bottleneck of downstream bioprocessing (DSB), by implementation of Seeding and Continuous Biopharmaceutical Crystallisation (SCoBiC), for the separation and purification of biopharmaceuticals. The ambition of this proposed project to develop strategies for a continuous biocrystallisation process, including selective crystallisation directly from multicomponent fermentation broths by seeding, for whole antibodies and antibody fragments. The goal is to reduce manufacturing costs, provide for simpler processes while achieving the high purity of material achievable from multi step chromatography. This ambition is driven by the awareness that separation and purification processes represent one of the most time and cost-intense downstream operations in the manufacture of commercial biopharmaceutical products. This proposal will develop a continuous biocrystallisation platform as an alternative to conventional DSB, offering improvements to manufacturability, enabling higher throughput, lowering the product costs, an increase in product quality and stability, including opportunities for novel formulations and technologies.