Continuous downstream bioprocessing for intensified manufacture of biopharmaceuticals and antibodies. (15th February 2021)

• Record Type: Journal Article
• Authors: Gerstweiler, Lukas; Bi, Jingxiu; Middelberg, Anton P.J.
• Is Part Of: Chemical engineering science. Volume 231(2021)
• Publication Date: 2021-02-15
• Subjects: Continuous processing -- Antibody -- Biopharmaceuticals -- Continuous purification -- Periodic counter current chromatography -- Downstream process development -- Process intensification; AEX Anion exchange -- ATF Alternating tangential flow filtration -- ATPs Aqueous two phase systems -- BSA Bovine serum albumin -- CEX Cation exchange -- CF Concentration factors -- CFIR Coiled ow inversion reactor -- CHO Chinese Hamster Ovary -- COG Cost of goods -- CCC Counter current chromatography -- CCTC Counter-current tangential chromatography -- CPC Centrifugal partition chromatography -- EDFM Electrodialysis with filtration membranes -- FDA Food and Drug Administration -- GCSF Granulocyte colony stimulating factor -- HCP Host cell protein -- IgG Immunoglobulin G -- IC Interconnected -- IEX Ion exchange -- PAT Process analytic technology -- PCC Periodic counter current -- PEG Polyethylene glycol -- P-CAC Preparative continuous annular chromatography -- MSB Mixer settler batteries -- MCSGP Multicolumn counter current solvent gradient purification -- mAb Monoclonal antibody -- OCC One-column continuous chromatography -- PAT Process analytic technologies -- sCPC Sequential centrifugal partition chromatography -- SEC Size Exclusion Chromatography -- SMCC Sequential multi-column chromatography -- SPDF Single pass diafiltration -- SPTFF Single pass tangential flow filtration -- SMB Simulated moving bed -- TPP Three-phase-partition -- TFF Tangential flow filtration -- TMB True moving bed -- VLPs Virus like particles; Chemical engineering -- Periodicals; Génie chimique -- Périodiques; Chemical engineering; Periodicals; Electronic journals; 660
• DOI: 10.1016/j.ces.2020.116272
• Languages: English
• ISSNs: 0009-2509

Abstract

Highlights: Continuous processing (CP) is delivering new efficiencies in biomanufacturing. The traditional focus on antibodies is being broadened to other biopharmaceuticals. CP can leap biomanufacturing into the 21 st C cementing it as an advanced industry. A process systems approach to integrated continuous bioprocess design is required. Further research is urgently needed to accelerate this new paradigm. Abstract: Continuous production delivers higher productivity and better quality than traditional batch-wise approaches. It intensifies production lowering capital cost and enables better control. Despite obvious advantages, continuous processing has not yet guided biomanufacturing to 21st Century Advanced Manufacturing status. Production relies primarily on batch-wise methods that have served the industry through its infancy. While great improvements have been achieved on the upstream side, downstream processing lacks development in continuous processing and is now the handbrake on modernisation. Nevertheless, there are hopeful advances. Research on continuous chromatographic purification for antibodies is maturing, and work has commenced on other unit operations and on process system integration. This exciting field of process intensification research is at a turning point, though considerably more research is needed. This review aims to summarize the latest developments and capabilities of continuous downstream processing applied in biopharmaceutical research and gives an overview of recent developments.