Biological medicines are therapies that contain one or more active ingredients produced or extracted from a biological system. For example, biological drugs are monoclonal antibodies (mAbs), some vaccines, blood components, hormones and many other biomolecules. Among the biological drugs, the most interesting from the therapeutic point of view are mAbs.
Whole antibodies, or their Fab fragments, are capable of recognizing and specifically binding proteins, or, in some cases, other organic molecules such as peptides, polysaccharides, glycoproteins, lipids, or nucleic acids, called antigens or epitopes. In virtue of their specific binding and subsequent neutralization of the target involved in the pathological state, mAbs are used in the treatment of tumours, inflammations, infectious events, cardiovascular diseases, rejection following organ transplants.
Industrially, mAbs are produced in batch bioreactors in the downstream processing (DSP) step. Then, they are purified to achieve biopharmaceutical quality standards by means of purification platforms consisting in a sequence of unitary operations which include centrifugation, filtration, affinity chromatography with protein-A, ion exchange chromatography (cation/anion), viral inactivation, ultrafiltration, diafiltration. The major limitation of this technological approach consists in the high cost of the protein-A based resin and the large amount of chemicals that are used for the regeneration of the chromatographic column after each purification step. This has an unsustainable economic and environmental impact that has to be mitigated to allow a larger portion of the world’s population to take the benefits of such therapies at affordable costs.
In this context, BIOPURE project has the overall purpose to deliver a step change in monoclonal antibodies purification through the implementation of radically new and disruptive technology based on membrane-assisted crystallization (MAC), for the recovery and purification of monoclonal antibodies in the solid state directly from clarified cell culture fluids (CCCF). The proposed approach has the potential to replace the protein A chromatographic step by an inexpensive, robust, environmentally sustainable and easily scalable process. By achieving the main objective 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. In this respect, 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.
