Biopharmaceuticals purification by continuous membrane-assisted crystallization achieving lower cost and intensified processes (BIOPURE)

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With the growing global demand for biological medicines to address new therapeutic areas, the BIOPURE project will deliver a step change in monoclonal antibodies (mAbs) purification through the implementation of radically new and disruptive technology to recover mAbs-products in the solid-state directly from cell-free culture fluids. BIOPURE promises to lower manufacturing and purchase of equipment costs with a smaller footprint. It simplifies logistic chains and enhances environmental sustainability by avoiding extensive use of chemicals, compared to the standard chromatography-based platforms. It opens the doors to new possibilities and biomedicines so far too challenging economically or technologically. As end result, the citizens will have access to a more affordable and diverse selection of new generation biomedicines. The proposed membrane-based technology has already been proved at the laboratory scale (TRL4) as a cheaper and easily scalable alternative to protein A chromatography for mAb purification. The next step is to demonstrate the generalized efficiency of the technology and scale it up to TRL6 through the design of a fully automatized prototype that will be operated continuously and capable of compliance with quality and regulations for biopharmaceutical productions. In addition to technological development, the new BIOPURE technology will be validated with real market players, leading to verifying the planned business model, the IPR management plan, and the associated financial planning included in the go-to-market strategy. By achieving the main objectives of BIOPURE, it is expected that the adoption of membrane-assisted method for mAb-products purification will provide a breakthrough advancement in terms of productivity efficiency via continuous manufacturing, and cost reduction via process intensification.