Upstream process intensification and continuous manufacturing

Current Opinion in Chemical Engineering - Tập 22 - Trang 191-198 - 2018
Chun Chen1, H Edward Wong1, Chetan T Goudar1
1Drug Substance Technologies, Process Development, Amgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA 91320, United States

Tài liệu tham khảo

2018 Zhou, 2014 Kelley, 2009, Industrialization of mAb prssoduction technology: the bioprocessing industry at a crossroads, MAbs, 1, 443, 10.4161/mabs.1.5.9448 Levine, 2012, Efficient, flexible facilities for the 21st century, Bioprocess Int, 10, 20 Gong, 2018, Development of PD-1 and PD-L1 inhibitors as a form of cancer immunotherapy: a comprehensive review of registration trials and future considerations, J Immunother Cancer, 6, 8, 10.1186/s40425-018-0316-z Database of privately and publicly funded clinical studies conducted around the world; URL: https://clinicaltrialsclinicaltrials.gov. Konstantinov, 2015, White paper on continuous bioprocessing may 20-21 2014 continuous manufacturing symposium, J Pharm Sci, 813, 10.1002/jps.24268 Walther, 2015, The business impact of an integrated continuous biomanufacturing platform for recombinant protein production, J Biotechnol, 213, 3, 10.1016/j.jbiotec.2015.05.010 Bonham-Carter, 2011, A brief history of perfusion biomanufacturing, BioProcess Int, 9, 24 Pollock, 2013, Fed-batch and perfusion culture processes: economic, environmental, and operational feasibility under uncertainty, Biotechnol Bioeng, 110, 206, 10.1002/bit.24608 Bielser, 2018, Perfusion mammalian cell culture for recombinant protein manufacturing - a critical review, Biotechnol Adv, 36, 1328, 10.1016/j.biotechadv.2018.04.011 Goudar, 2015, Integrated continuous biomanufacturing: a new paradigm for biopharmaceutical production, J Biotechnol, 213, 1, 10.1016/j.jbiotec.2015.08.015 Karst, 2017, Continuous integrated manufacturing of therapeutic proteins, Curr Opin Biotechnol, 53, 76, 10.1016/j.copbio.2017.12.015 Yang, 2016, Concentrated fed-batch cell culture increases manufacturing capacity without additional volumetric capacity, J Biotechnol, 217, 1, 10.1016/j.jbiotec.2015.10.009 Xu, 2017, Bioreactor productivity and media cost comparison for different intensified cell culture processes, Biotechnol Prog, 33, 867, 10.1002/btpr.2415 Shukla, 2013, Single-use disposable technologies for biopharmaceutical manufacturing, Trends Biotechnol, 31, 147, 10.1016/j.tibtech.2012.10.004 Wurm, 2004, Production of recombinant protein therapeutics in cultivated mammalian cells, Nat Biotechnol, 22, 1393, 10.1038/nbt1026 Kunert, 2016, Advances in recombinant antibody manufacturing, Appl Microbiol Biotechnol, 100, 3451, 10.1007/s00253-016-7388-9 Li, 2010, Cell culture processes for monoclonal antibody production, MAbs, 2, 466, 10.4161/mabs.2.5.12720 De Jesus, 2011, Manufacturing recombinant proteins in kg-ton quantities using animal cells in bioreactors, Eur J Pharm Biopharm, 78, 184, 10.1016/j.ejpb.2011.01.005 Birch, 2006, Antibody production, Adv Drug Deliv Rev, 58, 671, 10.1016/j.addr.2005.12.006 Huang, 2010, Maximizing productivity of CHO cell-based fed-batch culture using chemically defined media conditions and typical manufacturing equipment, Biotechnol Prog, 26, 1400, 10.1002/btpr.436 Bibila, 1995, In pursuit of the optimal fed-batch process for monoclonal antibody production, Biotechnol Prog, 11, 1, 10.1021/bp00031a001 Xie, 1994, Fed-batch cultivation of animal cells using different medium design concepts and feeding strategies, Biotechnol Bioeng, 43, 1175, 10.1002/bit.260431123 Lu, 2013, Automated dynamic fed-batch process and media optimization for high productivity cell culture process development, Biotechnol Bioeng, 110, 191, 10.1002/bit.24602 Clincke, 2013, Very high density of Chinese hamster ovary cells in perfusion by alternating tangential flow or tangential flow filtration in WAVE Bioreactor-part II: applications for antibody production and cryopreservation, Biotechnol Prog, 29, 768, 10.1002/btpr.1703 Zhang, 2015, Very high cell density perfusion of CHO cells anchored in a non-woven matrix-based bioreactor, J Biotechnol, 213, 28, 10.1016/j.jbiotec.2015.07.006 Wright, 2015, A novel seed-train process: using high-density cell banking, a disposable bioreactor, and perfusion technologies, BioProcess Int, 13 Yang, 2014, Perfusion seed cultures improve biopharmaceutical fed-batch production capacity and product quality, Biotechnol Prog, 30, 616, 10.1002/btpr.1884 Le, 2015, Continuous processing in upstream operations, Chem Eng Prog, 111, 32 Chatterjee, 2012, FDA perspective on continuous manufacturing, IFPAC Annual Meeting, 26, 34 Walther, 2018, Perfusion cell culture decreases process and product heterogeneity in a head-to-head comparison with fed-batch, Biotechnol J, 10.1002/biot.201700733 van Reis, 1991, Industrial scale harvest of proteins from mammalian cell culture by tangential flow filtration, Biotechnol Bioeng, 38, 413, 10.1002/bit.260380411 Kelly, 2014, Understanding and modeling alternating tangential flow filtration for perfusion cell culture, Biotechnol Prog, 30, 1291, 10.1002/btpr.1953 Karst, 2016, Characterization and comparison of ATF and TFF in stirred bioreactors for continuous mammalian cell culture processes, Biochem Eng J, 110, 17, 10.1016/j.bej.2016.02.003 Wang, 2017, Shear contributions to cell culture performance and product recovery in ATF and TFF perfusion systems, J Biotechnol, 246, 52, 10.1016/j.jbiotec.2017.01.020 Bosco, 2017, Alternating flow filtration as an alternative to internal spin filter based perfusion process: impact on productivity and product quality, Biotechnol Prog, 33, 1010, 10.1002/btpr.2487 Lin, 2017, Principles and approach to developing mammalian cell culture media for high cell density perfusion process leveraging established fed-batch media, Biotechnol Prog, 33, 891, 10.1002/btpr.2472 Hiller, 2017, Cell-controlled hybrid perfusion fed-batch CHO cell process provides significant productivity improvement over conventional fed-batch cultures, Biotechnol Bioeng, 114, 1438, 10.1002/bit.26259 Warikoo, 2012, Integrated continuous production of recombinant therapeutic proteins, Biotechnol Bioeng, 109, 3018, 10.1002/bit.24584 Voisard, 2003, Potential of cell retention techniques for large-scale high-density perfusion culture of suspended mammalian cells, Biotechnol Bioeng, 82, 751, 10.1002/bit.10629 Shirgaonkar, 2004, Acoustic cell filter: a proven cell retention technology for perfusion of animal cell cultures, Biotechnol Adv, 22, 433, 10.1016/j.biotechadv.2004.03.003 Gorenflo, 2002, Scale-up and optimization of an acoustic filter for 200 L/day perfusion of a CHO cell culture, Biotechnol Bioeng, 80, 438, 10.1002/bit.10386 Yardley, 2000, On-line, real-time measurements of cellular biomass using dielectric spectroscopy, Biotechnol Genet Eng Rev, 17, 3, 10.1080/02648725.2000.10647986 Justice, 2011, Process control in cell culture technology using dielectric spectroscopy, Biotechnol Adv, 29, 391, 10.1016/j.biotechadv.2011.03.002 Camisard, 2002, Inline characterization of cell concentration and cell volume in agitated bioreactors using in situ microscopy: application to volume variation induced by osmotic stress, Biotechnol Bioeng, 78, 73, 10.1002/bit.10178 Guez, 2004, Real time in situ microscopy for animal cell-concentration monitoring during high density culture in bioreactor, J Biotechnol, 111, 335, 10.1016/j.jbiotec.2004.04.028 Rathore, 2010, Process analytical technology (PAT) for biopharmaceutical products, Anal Bioanal Chem, 398, 137, 10.1007/s00216-010-3781-x Abu-Absi, 2011, Real time monitoring of multiple parameters in mammalian cell culture bioreactors using an in-line Raman spectroscopy probe, Biotechnol Bioeng, 108, 1215, 10.1002/bit.23023 Scarff, 2006, Near infrared spectroscopy for bioprocess monitoring and control: current status and future trends, Crit Rev Biotechnol, 26, 17, 10.1080/07388550500513677 Zhang, 2009, Mass spectrometry for structural characterization of therapeutic antibodies, Mass Spectrom Rev, 28, 147, 10.1002/mas.20190 Zhang, 2010, Prediction of collision-induced dissociation spectra of common N-glycopeptides for glycoform identification, Anal Chem, 82, 10194, 10.1021/ac102359u Shah, 2014, LC-MS/MS peptide mapping with automated data processing for routine profiling of N-glycans in immunoglobulins, J Am Soc Mass Spectrom, 25, 999, 10.1007/s13361-014-0858-3 Wong, 2018, Amino acid misincorporation in recombinant proteins, Biotechnol Adv, 36, 168, 10.1016/j.biotechadv.2017.10.006 Zhang, 2011, Prediction of collision-induced-dissociation spectra of peptides with post-translational or process-induced modifications, Anal Chem, 83, 8642, 10.1021/ac2020917 Sha, 2016, N-glycosylation design and control of therapeutic monoclonal antibodies, Trends Biotechnol, 34, 835, 10.1016/j.tibtech.2016.02.013 Hossler, 2009, Optimal and consistent protein glycosylation in mammalian cell culture, Glycobiology, 19, 936, 10.1093/glycob/cwp079 Liu, 2014, The availability of glucose to CHO cells affects the intracellular lipid-linked oligosaccharide distribution, site occupancy and the N-glycosylation profile of a monoclonal antibody, J Biotechnol, 170, 17, 10.1016/j.jbiotec.2013.11.007 Nyberg, 1999, Metabolic effects on recombinant interferon-gamma glycosylation in continuous culture of Chinese hamster ovary cells, Biotechnol Bioeng, 62, 336, 10.1002/(SICI)1097-0290(19990205)62:3<336::AID-BIT10>3.0.CO;2-N Gramer, 2011, Modulation of antibody galactosylation through feeding of uridine, manganese chloride, and galactose, Biotechnol Bioeng, 108, 1591, 10.1002/bit.23075 Yang, 2000, Effects of ammonia on CHO cell growth, erythropoietin production, and glycosylation, Biotechnol Bioeng, 68, 370, 10.1002/(SICI)1097-0290(20000520)68:4<370::AID-BIT2>3.0.CO;2-K Huang, 2015, A robust method for increasing Fc glycan high mannose level of recombinant antibodies, Biotechnol Bioeng, 112, 1200, 10.1002/bit.25534 Berkowitz, 2012, Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars, Nat Rev Drug Discov, 11, 527, 10.1038/nrd3746 Kirchhoff, 2017, Biosimilars: Key regulatory considerations and similarity assessment tools, Biotechnol Bioeng, 114, 2696, 10.1002/bit.26438 Fan, 2012, Improving the efficiency of CHO cell line generation using glutamine synthetase gene knockout cells, Biotechnol Bioeng, 109, 1007, 10.1002/bit.24365 Chen, 2016, Integration of systems biology in cell line and process development for biopharmaceutical manufacturing, Biochem Eng J, 107, 11, 10.1016/j.bej.2015.11.013 Bailey, 2012, Determination of Chinese hamster ovary cell line stability and recombinant antibody expression during long-term culture, Biotechnol Bioeng, 109, 2093, 10.1002/bit.24485 Yang, 2010, DNA methylation contributes to loss in productivity of monoclonal antibody-producing CHO cell lines, J Biotechnol, 147, 180, 10.1016/j.jbiotec.2010.04.004 Pikaart, 1998, Loss of transcriptional activity of a transgene is accompanied by DNA methylation and histone deacetylation and is prevented by insulators, Genes Dev, 12, 2852, 10.1101/gad.12.18.2852 Kim, 2011, A mechanistic understanding of production instability in CHO cell lines expressing recombinant monoclonal antibodies, Biotechnol Bioeng, 108, 2434, 10.1002/bit.23189 Moritz, 2015, CMV promoter mutants with a reduced propensity to productivity loss in CHO cells, Sci Rep, 5, 16952, 10.1038/srep16952 Rada-Iglesias, 2007, Butyrate mediates decrease of histone acetylation centered on transcription start sites and down-regulation of associated genes, Genome Res, 17, 708, 10.1101/gr.5540007 Yang, 2014, Addition of valproic acid to CHO cell fed-batch cultures improves monoclonal antibody titers, Mol Biotechnol, 56, 421, 10.1007/s12033-013-9725-x Chusainow, 2009, A study of monoclonal antibody-producing CHO cell lines: what makes a stable high producer?, Biotechnol Bioeng, 102, 1182, 10.1002/bit.22158 Vcelar, 2018, Changes in chromosome counts and patterns in CHO cell lines upon generation of recombinant cell lines and subcloning, Biotechnol J, 10.1002/biot.201700495 Vcelar, 2018, Karyotype variation of CHO host cell lines over time in culture characterized by chromosome counting and chromosome painting, Biotechnol Bioeng, 115, 165, 10.1002/bit.26453 Baik, 2017, Growth rate changes in CHO host cells are associated with karyotypic heterogeneity, Biotechnol J Ko, 2017, Probing the importance of clonality: single cell subcloning of clonally derived CHO cell lines yields widely diverse clones differing in growth, productivity, and product quality, Biotechnol Prog Xu, 2011, The genomic sequence of the Chinese hamster ovary (CHO)-K1 cell line, Nat Biotechnol, 29, 735, 10.1038/nbt.1932 Wuest, 2012, Genomics in mammalian cell culture bioprocessing, Biotechnol Adv, 30, 629, 10.1016/j.biotechadv.2011.10.010 Lewis, 2013, Genomic landscapes of Chinese hamster ovary cell lines as revealed by the Cricetulus griseus draft genome, Nat Biotechnol, 31, 759, 10.1038/nbt.2624 Kang, 2014, Cell line profiling to improve monoclonal antibody production, Biotechnol Bioeng, 111, 748, 10.1002/bit.25141 Yusufi, 2017, Mammalian systems biotechnology reveals global cellular adaptations in a recombinant CHO cell line, Cell Syst, 4, 530, 10.1016/j.cels.2017.04.009 Jadhav, 2013, CHO microRNA engineering is growing up: recent successes and future challenges, Biotechnol Adv, 31, 1501, 10.1016/j.biotechadv.2013.07.007 Orellana, 2018, RNA-Seq highlights high clonal variation in monoclonal antibody producing CHO cells, Biotechnol J, 13, 10.1002/biot.201700231 Korke, 2004, Large scale gene expression profiling of metabolic shift of mammalian cells in culture, J Biotechnol, 107, 1, 10.1016/j.jbiotec.2003.09.007 Lee, 2016, Accelerated homology-directed targeted integration of transgenes in Chinese hamster ovary cells via CRISPR/Cas9 and fluorescent enrichment, Biotechnol Bioeng, 113, 2518, 10.1002/bit.26002 Bunnak, 2016, Life-cycle and cost of goods assessment of fed-batch and perfusion-based manufacturing processes for mAbs, Biotechnol Prog, 32, 1324, 10.1002/btpr.2323