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Biopharmaceutical benchmarks 2018

Walsh, Gary·2018·Nature Biotechnology

DOI 10.1038/nbt.4305

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Car t cell immunotherapy for human cancer
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Background
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Background
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Background
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Background
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Background
Towards Autonomous Process Control—Digital Twin for CHO Cell-Based Antibody Manufacturing Using a Dynamic Metabolic Model
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“animal cells, mostly Chinese hamster ovary (CHO) cells [16,17].”
Background
Structural analysis of random transgene integration in CHO manufacturing cell lines by targeted sequencing
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“using Chinese hamster ovary (CHO) cell systems (Walsh, 2018).”
BackgroundMethodInfluential
A novel reactor configuration for continuous virus inactivation
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Development of a Novel, Fully Human, Anti-PCSK9 Antibody with Potent Hypolipidemic Activity by Utilizing Phage Display-Based Strategy
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“…IgG mAb being the most appropriate format for clinical applications because of its long half-life, high stability and bivalent binding property [64,65], we further constructed the full-length Fc-silenced anti-PCSK9 antibodies by fusing two anti-PCSK9 scFv variants (AP2M18 and AP2M21) to a modi ﬁ…”
Metabolic profiling of Chinese hamster ovary cell cultures at different working volumes and agitation speeds using spin tube reactors
Torres, M., Elvin, M., Betts, Z., Place, S., Gaffney, C. E., & Dickson, A. J. (2020) · Biotechnology Progress · doi:10.1002/btpr.3099 · Cited by 23
“Chinese hamster ovary (CHO) cell lines are the most preferred mammalian expression platform for the production of a broad range of recombinant (r-) proteins, including monoclonal antibodies (mAbs) and Fc fusion proteins.(1) Process development in CHO cell-based bioproduction can be a long and costly procedure, limited…”
Background
Surface biofunctionalization to improve the efficacy of biomaterial substrates to be used in regenerative medicine
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Chromatin-modifying elements for recombinant protein production in mammalian cell systems
Guo, X. H., Wang, C., & Wang, T. (2020) · Critical Reviews in Biotechnology · doi:10.1080/07388551.2020.1805401 · Cited by 21
Multi-Attribute Monitoring of Complex Erythropoetin Beta Glycosylation by GluC Liquid Chromatography–Mass Spectrometry Peptide Mapping
Buettner, A., Maier, M., Bonnington, L. S., Bulau, P., & Reusch, D. (2020) · Analytical Chemistry · doi:10.1021/acs.analchem.0c00124 · Cited by 22
Optimized CRISPR/Cas9 Strategy for Homology-Directed Multiple Targeted Integration of Transgenes in CHO Cells.
Shin, S., & Lee, J. S. (2019) · Biotechnology and Bioengineering · doi:10.22541/au.157550577.76346516 · Cited by 19
“Given the major clinical and commercial success of monoclonal antibody therapeutics and the emergence of next-generation difficult-to-express antibody products, including multi-specific antibody formats and fusion proteins (Spiess et al., 2015; Walsh, 2018), the demand for multiple KI based CLD will continue to grow b…”
Background
Prompting Fab Yeast Surface Display Efficiency by ER Retention and Molecular Chaperon Co-expression
Mei, M., Li, J., Wang, S., Lee, K. B., Iverson, B. L., Zhang, G., Ge, X., & Li, Y. (2019) · Frontiers in Bioengineering and Biotechnology · doi:10.3389/fbioe.2019.00362 · Cited by 28
“By the end of 2018, at least 116 mAb-based biopharmaceutical products are active on the market (Walsh, 2018; DeFrancesco, 2019).”
Background
Feedback-responsive cell factories for dynamic modulation of the unfolded protein response
Barrios, D., Bachhav, B., Carlos‐Alcalde, W., Llanos, C. P., Zhou, W., & Segatori, L. (2025) · Nature Communications · doi:10.1038/s41467-025-58994-x · Cited by 15
“Due to their fundamental role in diverse biological processes, protein therapeutics are used to treat many diseases, from acute ischemic strokes to rheumatoid arthritis and cancer 1 .”
Behavior of host-cell-protein-rich aggregates in antibody capture and polishing chromatography
Herman, C. E., Min, L., Choe, L., Maurer, R. W., Xu, X.-K., Ghose, S., Lee, K. H., & Lenhoff, A. (2023) · Journal of Chromatography A · doi:10.1016/j.chroma.2023.464081 · Cited by 18
Deep learning-based codon optimization with large-scale synonymous variant datasets enables generalized tunable protein expressionPreprint
Constant, D. A., Gutierrez, J. M., Sastry, A. V., Viazzo, R., Smith, N. R., Hossain, J., Spencer, D. A., Carter, H., Ventura, A. B., Louie, M. T. M., et al. (2023) · bioRxiv (Cold Spring Harbor Laboratory) · doi:10.1101/2023.02.11.528149 · Cited by 21
“As of 2018, there were 316 licensed proteinbased biopharmaceutical products with sales totaling at least $651 billion since 2014 [2].”
Background
CRISPR‐interceded CHO cell line development approaches
Amiri, S., Adibzadeh, S., Ghanbari, S., Rahmani, B., Kheirandish, M. H., Farokhi‐Fard, A., Dastjerdeh, M. S., & Davami, F. (2023) · Biotechnology and Bioengineering · doi:10.1002/bit.28329 · Cited by 21
“In the case of monoclonal antibodies (mAbs) as an essential section in biopharmaceuticals, this fact is more pronounced considering that 84% (57 of the 68 mAb products approved till the end of July 2018) are produced in CHO platforms (Walsh, 2018).”
Background
3D-LC-MS with 2D Multimethod Option for Fully Automated Assessment of Multiple Attributes of Monoclonal Antibodies Directly from Cell Culture Supernatants.
Verscheure, L., Vanhoenacker, G., Schneider, S., Merchiers, T., Storms, J., Sandra, P., Lynen, F., & Sandra, K. (2022) · Analytical Chemistry · doi:10.1021/acs.analchem.1c05461 · Cited by 18
Restoration of DNA repair mitigates genome instability and increases productivity of Chinese hamster ovary cells
Spahn, P. N., Zhang, X., Hu, Q., Lu, H., Hamaker, N. K., Hefzi, H., Li, S., Kuo, C., Huang, Y., Lee, J. C., et al. (2021) · Biotechnology and Bioengineering · doi:10.1002/bit.28016 · Cited by 22
“…of therapeutic proteins for over 40 years, and projections show they will maintain this dominant position into the foreseeable future because they produce >80% of therapeutic proteins approved between 2014 and 2018, corresponding to more than $100 billion of products per year (Walsh, 2018).”
Background
DigiGlyc: A hybrid tool for reactive scheduling in cell culture systems
Kotidis, P., Pappas, I. S., Avraamidou, S., Pistikopoulos, E. N., Kontoravdi, C., & Papathanasiou, M. M. (2021) · Computers & Chemical Engineering · doi:10.1016/j.compchemeng.2021.107460 · Cited by 17
A proline metabolism selection system and its application to the engineering of lipid biosynthesis in Chinese hamster ovary cells
Budge, J. D., Roobol, J., Singh, G., Mozzanino, T., Knight, T. J., Povey, J. F., Dean, A., Turner, S. J., Jaques, C. M., Young, R. J., et al. (2021) · Metabolic Engineering Communications · doi:10.1016/j.mec.2021.e00179 · Cited by 20
“Chinese hamster ovary (CHO) cells are the expression system most widely used to produce complex human-like recombinant proteins such as monoclonal antibodies (mAbs) (Walsh, 2018).”
Background
Compartmentalized Proteomic Profiling Outlines the Crucial Role of the Classical Secretory Pathway during Recombinant Protein Production in Chinese Hamster Ovary Cells
Rodriguez, S. P., Wulff, T., Voldborg, B. G. R., Altamirano, C., Trujillo‐Roldán, M. A., & Valdez‐Cruz, N. A. (2021) · ACS Omega · doi:10.1021/acsomega.0c06030 · Cited by 20
Application of metabolic modeling for targeted optimization of high seeding density processes
Brunner, M., Kolb, K., Keitel, A., Stiefel, F., Wucherpfennig, T., Bechmann, J., Unsoeld, A., & Schaub, J. (2021) · Biotechnology and Bioengineering · doi:10.1002/bit.27693 · Cited by 21
“Increases in biopharmaceutical product approvals over the last years, as well as a high number of molecules currently in clinical development and an anticipated growth of the biosimilar market, will challenge future manufacturing capacities (Bielser et al., 2018; Walsh, 2018).”
Background
High-surface-area interconnected macroporous nanofibrous cellulose microspheres: a versatile platform for large capacity and high-throughput protein separation
Qiao, L., Lei, S., & Du, K. (2021) · Cellulose · doi:10.1007/s10570-020-03654-0 · Cited by 18
“…as an indispensable part of biomacromolecules, not only play critical roles in fundamental biological processes including receptor activation, immune response, and intracellular transport, but also occupy important status in biotechnological and biopharmaceutical industry (Smith 2005; Walsh 2018).”
Background
Development and application of a cultivation platform for mammalian suspension cell lines with single‐cell resolution
Schmitz, J., Täuber, S., Westerwalbesloh, C., von Lieres, E., Noll, T., & Grünberger, A. (2020) · Biotechnology and Bioengineering · doi:10.1002/bit.27627 · Cited by 19
“As CHO cell lines are the most frequently used cells in biopharmaceutical bioproduction processes (Walsh, 2018), CHO‐K1 cells were used as a model system for the developed microfluidic device.”
Method
Binding mechanism of functional moieties of a mixed-mode ligand in antibody purification
Li, M.-T., Zou, X.-J., Zhang, Q.-L., Lin, D.-Q., & Yao, S.-J. (2020) · doi:10.1016/j.cej.2020.125887 · Cited by 18
Effects of Hydrophobic Tail Length Variation on Surfactant-Mediated Protein Stabilization
Hanson, M. G., Katz, J. S., Ma, H., Putterman, M., Yezer, B. A., Petermann, O., & Reineke, T. M. (2020) · Molecular Pharmaceutics · doi:10.1021/acs.molpharmaceut.0c00737 · Cited by 21
A Chinese hamster transcription start site atlas that enables targeted editing of CHO cells
Shamie, I., Duttke, S. H. C., Karottki, K. J. L. C., Han, C. Z., Hansen, A. H., Hefzi, H., Xiong, K., Li, S., Roth, S. J., Tao, J., et al. (2021) · NAR Genomics and Bioinformatics · doi:10.1093/nargab/lqab061 · Cited by 16
“As of 2018, 84% of FDA approved monoclonal antibodies were produced in CHO cells (1) and by sales in 2020, 5 out of the top 10 drugs are CHO-derived recombinant proteins (4).”
Background
Direct Comparison of Label-Free Biosensor Binding Kinetics Obtained on the Biacore 8K and the Carterra LSA
Knowling, S. E., Clark, J., Sjuts, H., & Abdiche, Y. (2020) · SLAS discovery : advancing life sciences R & D · doi:10.1177/2472555220934814 · Cited by 18
A Generic Procedure for the Isolation of pH- and Magnesium-Responsive Chicken scFvs for Downstream Purification of Human Antibodies
Hinz, S. C., Elter, A., Rammo, O., Schwämmle, A., Ali, A., Zielonka, S., Herget, T., & Kolmar, H. (2020) · Frontiers in Bioengineering and Biotechnology · doi:10.3389/fbioe.2020.00688 · Cited by 18
“This leads to an increase in competitive pressure, a motivation for research and development of new low-cost production and purification strategies (Walsh, 2018).”
Background
Photosensitizing proteins for antibacterial photodynamic inactivation
Hally, C., Delcanale, P., Nonell, S., Viappiani, C., & Abbruzzetti, S. (2020) · Translational Biophotonics · doi:10.1002/tbio.201900031 · Cited by 18
Production of recombinant human type I collagen homotrimers in CHO cells and their physicochemical and functional properties
Wang, C., Guo, X., Fan, M., Yue, L., Wang, H., Wang, J., Zha, Z., & Yin, H. (2024) · Journal of Biotechnology · doi:10.1016/j.jbiotec.2024.09.011 · Cited by 17
Biosynthesis of protein-based drugs using eukaryotic microalgae
Xie, Z., He, J., Peng, S., Zhang, X., & Kong, W. (2023) · Algal Research · doi:10.1016/j.algal.2023.103219 · Cited by 21
Apilimod enhances specific productivity in recombinant CHO cells through cell cycle arrest and mediation of autophagy
Lu, J.-T., Xiao, M., Feng, Y., Wang, X.-Y., Qiu, L.-L., Chai, Y.-R., Wang, T.-Y., & Jia, Y.-L. (2022) · Biotechnology Journal · doi:10.1002/biot.202200147 · Cited by 17
“Chinese hamster ovary (CHO) cell line is one of the significant mammalian hosts for therapeutic protein production.[1] Improving the”
Background
Dynamic simulation, optimisation and economic analysis of fed-batch vs. perfusion bioreactors for advanced mAb manufacturing
Jones, W., & Gerogiorgis, D. (2022) · Computers and Chemical Engineering · doi:10.1016/j.compchemeng.2022.107855 · Cited by 17
Gene delivery strategies for therapeutic proteins production in plants: Emerging opportunities and challenges.
Peng, L.-H., Gu, T.-W., Xu, Y., Dad, H. A., Liu, J.-X., Lian, J.-Z., & Huang, L.-Q. (2021) · Biotechnology Advances · doi:10.1016/j.biotechadv.2021.107845 · Cited by 17
A comparative analysis of recombinant Fab and full‐length antibody production in Chinese hamster ovary cells
Hussain, H., Patel, T., Ozanne, A. M. S., Vito, D., Ellis, M., Hinchliffe, M., Humphreys, D. P., Stephens, P. E., Sweeney, B., White, J., et al. (2021) · Biotechnology and Bioengineering · doi:10.1002/bit.27944 · Cited by 18
“The Fab antibody fragment Idarucizumab (Praxbind®) has also been approved for neutralization of the anticoagulant effect of dabigatran (Walsh, 2018).”
BackgroundInfluential
Towards rational glyco-engineering in CHO: from data to predictive models
Štor, J., Ruckerbauer, D. E., Széliová, D., Zanghellini, J., & Borth, N. (2021) · Current Opinion in Biotechnology · doi:10.1016/j.copbio.2021.05.003 · Cited by 19
“The most widely used expression systems for biotherapeutics are Chinese hamster ovary (CHO) cell lines [3].”
Background
Discrepancies between High-Resolution Native and Glycopeptide-Centric Mass Spectrometric Approaches: A Case Study into the Glycosylation of Erythropoietin Variants
Čaval, T., Buettner, A., Haberger, M., Reusch, D., & Heck, A. J. R. (2021) · Journal of the American Society for Mass Spectrometry · doi:10.1021/jasms.1c00060 · Cited by 20
Proteomic Profiling of IgG1 Producing CHO Cells Using LC/LC-SPS-MS3: The Effects of Bioprocessing Conditions on Productivity and Product Quality
Strasser, L., Farrell, A., Ho, J. T. C., Scheffler, K., Cook, K., Pankert, P., Mowlds, P., Viner, R., Karger, B. L., & Bones, J. (2021) · Frontiers in Bioengineering and Biotechnology · doi:10.3389/fbioe.2021.569045 · Cited by 17
“With an increasing number of approvals every year, the biopharmaceutical market is dominated by monoclonal antibodies (mAbs) which are most commonly produced in Chinese hamster ovary (CHO) cells (Kaplon and Reichert, 2018; Walsh, 2018).”
Background
CHOK1SV GS‐KO SSI expression system: A combination of the Fer1L4 locus and glutamine synthetase selection
Feary, M., Moffat, M. A., Casperson, G. F., Allen, M. J., & Young, R. J. (2021) · Biotechnology Progress · doi:10.1002/btpr.3137 · Cited by 15
“Of the 68 mAb products approved in 2014–2016, 84% used a CHObased expression system, with the remaining approved antibodies produced in either NS0 cells (9 products) or Sp2/0 cells (2 products).(3) The GS Gene Expression System was initially developed for use in adherent CHO-K1 cells,(4) requiring the use of the MSX a…”
Method
PEGylation of recombinant human deoxyribonuclease I deceases its transport across lung epithelial cells and uptake by macrophages.
Mahri, S., Hardy, E., Wilms, T., Keersmaecker, H. D., Braeckmans, K., Smedt, S. D., Bosquillon, C., & Vanbever, R. (2020) · International journal of pharmaceutics · doi:10.1016/j.ijpharm.2020.120107 · Cited by 17
“Currently, the number of approved products with distinct active protein ingredients exceeds a couple of hundred products, and many more are in clinical trials [3].”
Background
Comparison of protein precipitation methods for sample preparation prior to proteomic analysis of Chinese hamster ovary cell homogenates
Rodriguez, S. P., Ramírez, O. T., Trujillo‐Roldán, M. A., & Valdez‐Cruz, N. A. (2020) · Electronic Journal of Biotechnology · doi:10.1016/j.ejbt.2020.09.006 · Cited by 19
“Their importance is reflected in the number of these drugs approved, ranging from 16 during 1990–1994 to 112 in the period from 2015 to 2018 [62].”
Background
Decision Making and Risk Management in Biopharmaceutical Engineering—Opportunities in the Age of Covid-19 and Digitalization
Sokolov, M. (2020) · Industrial & Engineering Chemistry Research · doi:10.1021/acs.iecr.0c02994 · Cited by 17
Combining lipoic acid to methylene blue reduces the Warburg effect in CHO cells: From TCA cycle activation to enhancing monoclonal antibody production
Montégut, L., Martínez-Basilio, P. C., Moreira, J. D. V., Schwartz, L. H., & Jolicœur, M. (2020) · PLoS ONE · doi:10.1371/journal.pone.0231770 · Cited by 19
“Chinese Hamster Ovary (CHO) cells are considered to be the primary platform for the production of monoclonal antibodies (mAb) and other complex biopharmaceuticals [1].”
Background
Computer-Aided Strategies for Determining the Amino Acid Composition of Medium for Chinese Hamster Ovary Cell-Based Biomanufacturing Platforms
Traustason, B., Cheeks, M., & Dikicioǧlu, D. (2019) · International Journal of Molecular Sciences · doi:10.3390/ijms20215464 · Cited by 20
“CHO cells are predominantly used as expression hosts for recombinant monoclonal antibody (mAb) production, which comprises the fastest growing segment of the biopharmaceutical industry [2].”
Background

Authors: Walsh, G.
Affiliations: University of Limerick (IE)
Corresponding author: Walsh, Gary
ORCID: Walsh, Gary
Venue: Nature Biotechnology
Publisher: Springer Science and Business Media LLC
Published: 2018-12
Volume: 36
Issue: 12
Pages: 1136-1145
ISSN: 0733-222X (ISSN-L)
1087-0156
1546-1696
DOI: 10.1038/nbt.4305
OpenAlex: W2917928050
Cited by: 978
References: 15
Citations by year: 2026: 68 · 2025: 68 · 2024: 88 · 2023: 141 · 2022: 173 · 2021: 197 · 2020: 173 · 2019: 65
FWCI: 165.34
Type: journal article
Language: en
Open access: closed
Licence: www.springernature.com/gp/researchers/text-and-data-mining (tdm)
www.springernature.com/gp/researchers/text-and-data-mining (vor)
Locations: Nature Biotechnology (publishedVersion)
PubMed (publishedVersion)
Topics: Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
Life Sciences › Immunology and Microbiology › Immunology › Monoclonal and Polyclonal Antibodies Research
Keywords: biopharmaceutical market, monoclonal antibodies, cell therapy, gene therapy, biosimilars, biologics, market growth
MeSH terms: Animals, Antibodies, Monoclonal, Biological Products, Biotechnology, Drug Industry, European Union, Humans, Nucleic Acids, Recombinant Proteins, United States, United States Food and Drug Administration, Drug Approval, Benchmarking, Biosimilar Pharmaceuticals

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