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An ultra scale-down characterization of low shear stress primary recovery stages to enhance selectivity of fusion protein recovery from its molecular variants

This is a first characterisation of the challenges of recovery of a next generation biopharmaceutical product; an engineered fusion protein used to promote a selective immune response. Ultra scale-down methods (see USD Technologies impact case study) were used to create a new understanding of how process stress affects the presence of near-neighbour contaminating molecules as well as a range of non-protein contaminants. This paper has provided a first USD demonstration of the value of a low stress cell culture and recovery sequence involving centrifugation or depth filtration and shown how successful early predictions of full scale operations may be achieved.