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Biopharmaceutical benchmarks 2018

Walsh, Gary·2018·Nature Biotechnology

DOI 10.1038/nbt.4305

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“…production, specific demands for human post-translational modifications for certain r-proteins have made HEK293 successful alternatives to the conventional CHO cells and in 2018 five approved protein therapeutics were produced in HEK293 cell lines (Dumont et al., 2016; Walsh, 2018).”
Background
Nanotechnology‐Assisted RNA Delivery: From Nucleic Acid Therapeutics to COVID‐19 Vaccines
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“Moss-based biopharmaceuticals As high-value pharmaceutical products, recombinant pharmaceutical proteins display an increasing sector within the pharmaceutical market [31].”
Background
Engineering of Chinese hamster ovary cell lipid metabolism results in an expanded ER and enhanced recombinant biotherapeutic protein production
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“combinant molecules, but particularly mAbs (Walsh, 2018).”
Background
From anaerobic digestion to single cell protein synthesis: A promising route beyond biogas utilization
Li, R., Fan, X., Jiang, Y., Wang, R., Guo, R., Zhang, Y., & Fu, S. (2023) · Water Research · doi:10.1016/j.watres.2023.120417 · Cited by 58
Enhanced performance of polymer-polymer aqueous two-phase systems using ionic liquids as adjuvants towards the purification of recombinant proteins
Castro, L. S., Pereira, P., Passarinha, L., Freire, M., & Pedro, A. (2020) · doi:10.1016/j.seppur.2020.117051 · Cited by 51
Enhanced Protein Adsorption Capacity of Macroporous Pectin Particles with High Specific Surface Area and an Interconnected Pore Network.
Nguyen, T., Miyauchi, M., Rahmatika, A. M., Cao, K. L. A., Tanabe, E., & Ogi, T. (2022) · ACS Applied Materials and Interfaces · doi:10.1021/acsami.1c22307 · Cited by 50
A critical review on exploitation of agro-industrial biomass as substrates for the therapeutic microbial enzymes production and implemented protein purification techniques
Raina, D., Kumar, V., & Saran, S. (2022) · Chemosphere · doi:10.1016/j.chemosphere.2022.133712 · Cited by 60
Unraveling what makes a monoclonal antibody difficult‐to‐express: From intracellular accumulation to incomplete folding and degradation via ERAD
Mathias, S., Wippermann, A., Raab, N., Zeh, N., Handrick, R., Gorr, I. H., Schulz, P., Fischer, S., Gamer, M., & Otte, K. (2019) · Biotechnology and Bioengineering · doi:10.1002/bit.27196 · Cited by 55
Purification of Modified Therapeutic Proteins Available on the Market: An Analysis of Chromatography-Based Strategies
Sánchez‐Trasviña, C., Flores-Gatica, M., Enriquez-Ochoa, D., Rito‐Palomares, M., & Mayolo‐Deloisa, K. (2021) · Frontiers in Bioengineering and Biotechnology · doi:10.3389/fbioe.2021.717326 · Cited by 63
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BackgroundInfluential
Comprehensive Analysis of Genomic Safe Harbors as Target Sites for Stable Expression of the Heterologous Gene in HEK293 Cells
Shin, S., Kim, S. H., Shin, S. W., Grav, L. M., Pedersen, L. E., Lee, J. S., & Lee, G. M. (2020) · ACS Synthetic Biology · doi:10.1021/acssynbio.0c00097 · Cited by 60
Perspectives for Glyco-Engineering of Recombinant Biopharmaceuticals from Microalgae
Barolo, L., Abbriano, R. M., Commault, A. S., George, J., Kahlke, T., Fabris, M., Padula, M. P., Lopez, A., Ralph, P. J., & Pernice, M. (2020) · Cells · doi:10.3390/cells9030633 · Cited by 66
“Few recombinant biopharmaceuticals produced in alternative host systems have successfully passed clinical trials and reached commercialization status [2,78].”
Background
An optimized genome-wide, virus-free CRISPR screen for mammalian cells
Xiong, K., Karottki, K. J. L. C., Hefzi, H., Li, S., Grav, L. M., Li, S., Spahn, P. N., Lee, J. S., Ventiņa, I., Lee, G. M., et al. (2021) · Cell Reports Methods · doi:10.1016/j.crmeth.2021.100062 · Cited by 38
“In this study, we present a new VF CRISPR screening platform and demonstrate it in CHO cells, the model of choice for producing pharmaceutical proteins (Walsh, 2018).”
Chromosome‐scale scaffolds for the Chinese hamster reference genome assembly to facilitate the study of the CHO epigenome
Hilliard, W., MacDonald, M. L., & Lee, K. H. (2020) · Biotechnology and Bioengineering · doi:10.1002/bit.27432 · Cited by 48
“CHO cells have several advantageous characteristics, including robust growth in suspension culture and the ability to generate proteins with human‐ like glycosylation patterns, that have led to their long history of use as a workhorse organism to produce many recombinant proteins, and monoclonal antibodies (mAbs) in p…”
Background
Attenuating apoptosis in Chinese hamster ovary cells for improved biopharmaceutical production
Henry, M. N., MacDonald, M. A., Orellana, C. A., Gray, P. P., Gillard, M., Baker, K. N., Nielsen, L. K., Marcellin, E., Mahler, S. M., & Martínez, V. S. (2020) · Biotechnology and Bioengineering · doi:10.1002/bit.27269 · Cited by 51
“Introduction The global biotherapeutics market was valuated at $188 billion USD in 2017 (Walsh, 2018) and continues to grow.”
Screening Strategies for High-Yield Chinese Hamster Ovary Cell Clones
Yang, W., Zhang, J., Xiao, Y., Li, W., & Wang, T. (2022) · Frontiers in Bioengineering and Biotechnology · doi:10.3389/fbioe.2022.858478 · Cited by 47
“Among the top 10 drugs in global sales in 2019, eight are biopharmaceuticals, and seven are monoclonal antibodies produced in CHO cells (Walsh, 2018; Bhutani et al., 2021), mainly due to its ability to express various recombinant proteins with a post translational modification pattern similar to…”
Background
Real‐time amino acid and glucose monitoring system for the automatic control of nutrient feeding in CHO cell culture using Raman spectroscopy
Domján, J., Pantea, E., Gyürkés, M., Madarász, L., Kozák, D., Farkas, A., Horváth, B., Benkő, Z., Nagy, Z. K., Marosi, G., et al. (2022) · Biotechnology Journal · doi:10.1002/biot.202100395 · Cited by 49
“Chinese hamster ovary (CHO) cells are themost commonly usedmammalian host organism for the production of high-value therapeutic monoclonal antibodies (mAbs).[1,2] The process performance of CHO cell cultures strongly depends on the cultivation conditions prevailing”
Background
Progress of cationic gene delivery reagents for non-viral vector
Ma, K., Mi, C.-L., Cao, X.-X., & Wang, T.-Y. (2021) · Applied Microbiology and Biotechnology · doi:10.1007/s00253-020-11028-6 · Cited by 46
“Mammalian cells e expression systems have some advantages compared with other expression system, such as Escherichia coli, yeast, and insect cells (Walsh 2018).”
Background
A Green Chemistry Continuum for a Robust and Sustainable Active Pharmaceutical Ingredient Supply Chain
Koenig, S. G., Bee, C., Borovika, A., Briddell, C., Colberg, J. C., Humphrey, G. R., Kopach, M. E., Martínez, I., Nambiar, S., Plummer, S., et al. (2019) · ACS Sustainable Chemistry & Engineering · doi:10.1021/acssuschemeng.9b02842 · Cited by 62
Folding of heterologous proteins in bacterial cell factories: Cellular mechanisms and engineering strategies
Rong, Y., Jensen, S. I., Lindorff‐Larsen, K., & Nielsen, A. T. (2022) · Biotechnology Advances · doi:10.1016/j.biotechadv.2022.108079 · Cited by 47
Refolding in the modern biopharmaceutical industry
Buscajoni, L., Martinetz, M. C., Berkemeyer, M., & Brocard, C. (2022) · Biotechnology Advances · doi:10.1016/j.biotechadv.2022.108050 · Cited by 52
Full-length recombinant antibodies from Escherichia coli : production, characterization, effector function (Fc) engineering, and clinical evaluation
Rashid, M. H. (2022) · mAbs · doi:10.1080/19420862.2022.2111748 · Cited by 47
“It remains a popular host as evidenced by its use in the production of more than 85 approved drugs, and many more protein therapeutics in clinical and preclinical development.(3,4) This popularity stems from its fast growth, low cost of production, easy handling, versatile genetic manipulation, high productivity, and…”
Background
The cell density effect in animal cell-based bioprocessing: Questions, insights and perspectives
Lavado‐García, J., Pérez‐Rubio, P., Cervera, L., & Gòdia, F. (2022) · Biotechnology Advances · doi:10.1016/j.biotechadv.2022.108017 · Cited by 47
β-Glucans from Yeast—Immunomodulators from Novel Waste Resources
Thomas, S., Rezoagli, E., Abidin, I. Z., Major, I., Murray, P., & Murphy, E. J. (2022) · Applied Sciences · doi:10.3390/app12105208 · Cited by 54
Yeasts as Biopharmaceutical Production Platforms
Kulagina, N., Besseau, S., Godon, C., Goldman, G., Papon, N., & Courdavault, V. (2021) · Frontiers in Fungal Biology · doi:10.3389/ffunb.2021.733492 · Cited by 45
“Following the first murine mAb approved and commercialized in 1986 to prevent kidney transplant rejection, more than 100 mAbs were developed (Walsh, 2018).”
BackgroundInfluential
Integrative overview of antibodies against SARS-CoV-2 and their possible applications in COVID-19 prophylaxis and treatment
Valdez‐Cruz, N. A., García‐Hernández, E., Espitia, C., Cobos-Marín, L., Altamirano, C., Bando-Campos, C. G., Cofas‐Vargas, L. F., Coronado-Aceves, E. W., González-Hernández, R. A., Hernández‐Peralta, P., et al. (2021) · Microbial Cell Factories · doi:10.1186/s12934-021-01576-5 · Cited by 52
Multicopy Targeted Integration for Accelerated Development of High-Producing Chinese Hamster Ovary Cells
Sergeeva, D., Lee, G. M., Nielsen, L. K., & Grav, L. M. (2020) · ACS Synthetic Biology · doi:10.1021/acssynbio.0c00322 · Cited by 60
Protein materials as sustainable non- and minimally invasive strategies for biomedical applications
Stie, M. B., Kalouta, K., Vetri, V., & Foderà, V. (2022) · Journal of Controlled Release · doi:10.1016/j.jconrel.2022.02.016 · Cited by 57
Temperature-responsive chromatography for bioseparations: A review
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Particles in Biopharmaceutical Formulations, Part 2: An Update on Analytical Techniques and Applications for Therapeutic Proteins, Viruses, Vaccines and Cells
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Temperature Down‐Shift Modifies Expression of UPR‐/ERAD‐Related Genes and Enhances Production of a Chimeric Fusion Protein in CHO Cells
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Coupling non-denaturing chromatography to mass spectrometry for the characterization of monoclonal antibodies and related products
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Towards a new avenue for producing therapeutic proteins: Microalgae as a tempting green biofactory
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The Rocky Road From Fed-Batch to Continuous Processing With E. coli
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“Even though biopharmaceutical production is generally still carried out batch-wise, new technology has emerged (Walsh, 2014, 2018), and many drugs can currently be sold at the cheapest prices ever (Berlec and Strukelj, 2013; Jungbauer, 2013; Walsh, 2018).”
Background
Cost–Benefit Analysis of Monoclonal Antibody Cultivation Scenarios in Terms of Life Cycle Environmental Impact and Operating Cost
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Recent applications of ion mobility spectrometry in natural product research
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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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