Continuous Manufacturing Processes for Biotechnological Products MasterClass

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The environment for recombinant proteins used as biotherapeutics is changing. In the context of developing new biological entities, the bioindustry should further improve speed to clinic, gain in manufacturing flexibility while reducing costs of good sales (COGS). Despite at start of the recombinant era in the 80s/90s, continuous upstream processes have been applied especially for sensitive molecules such as hormones, cytokines and blood factors, the development of monoclonal antibodies as drugs was mainly based on large-scale fed-batch upstream connected to chromatography-based purification operated in batch. However, since the last ten years, it seems that the productivity of manufacturing processes of recombinant proteins based on large-scale fed-batch and classical chromatography processes has reached a plateau. As new technologies in cell separation and automatization of chromatographybased processes emerged, continuous manufacturing becomes a valid option for improving manufacturing productivity, flexibility and COGS. Whereas continuous manufacturing is now well considered for small molecules, it is not yet the case for biologics. Despite, some challenges still exist in applying continuous manufacturing processing for biologics, that approach could address some of the current limitations of largescale fed-batch processes.