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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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“Mammalian cell lines are used in approximately 80% of approved recombinant therapeutics due to humanized glycosylation patterns, consistent protein folding, and high production and secretion of proteins of interest (Walsh 2018).”
Background
Understanding the transcriptional response to ER stress in Chinese hamster ovary cells using multiplexed single cell RNA-seqPreprint
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“Chinese hamster ovary (CHO) cells are the most commonly used expression host for the manufacture of recombinant therapeutic proteins such as monoclonal antibodies (Walsh, 2018).”
Background
High‐density adherent culture of CHO cells using rolled scaffold bioreactor
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Background
Biological Treatments and Target Therapies for Pediatric Respiratory Medicine: Not Only Asthma
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“This broad definition includes blood components, hormones, cellular therapies, and even gene therapies (1).”
Background
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“Study Sample To identify all therapeutic mAbs previously approved by the FDA, we performed a search of the FDALabel database(4) for currently available lists of biological agents from the FDA’s Center for Biologics Evaluation and Research, Micromedex (IBM), and relevant literature, with a search date completion of Mar…”
Method
Strategies for Continuous Processing in Microbial Systems
Kopp, J., Slouka, C., Delvigne, F., & Herwig, C. (2021) · Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing · doi:10.1002/9783527827343.ch1 · Cited by 5
Commercial-scale Economic Comparison of Different Batch Modes for Upstream and Downstream Processing of Monoclonal Antibody
Cha, H.-M., Hwang, J.-M., Yeon, J.-H., Lim, J.-H., Han, H., & Kim, D. (2021) · Biotechnology and Bioprocess Engineering · doi:10.1007/s12257-020-0389-7 · Cited by 5
“Monoclonal antibodies (mAbs), Fc-fusion proteins, and cytokines are some of the best-selling biopharmaceutical products, and their use will continue to increase [1].”
Background
Production, purification and characterization of a double-tagged TEV protease.
Rizza, J., Ortega, C., Carrión, F., Fló, M., & Correa, A. (2021) · Protein Expression and Purification · doi:10.1016/j.pep.2021.106021 · Cited by 5
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“Today, Chinese hamster ovary (CHO) cells are by far the most popular system in use [1] because they are known to be easy to grow; safe as far as not carrying any infectious agents; and last but not least, highly productive with yields in the multiple grams per liter range [2,3].”
Background
Harnessing the potential of bacterial oxidative folding to aid protein production
Slater, S. L., & Mavridou, D. A. I. (2021) · Molecular Microbiology · doi:10.1111/mmi.14700 · Cited by 7
“A major perceived disadvantage of bacterial expression strains is that they require extensive engineering to produce these PTMs non- natively; on the contrary, the aberrant PTM introduction that confounds yeast, insect, or mammalian systems can be avoided by using bacteria (Tripathi & Shrivastava, 2019).”
BackgroundInfluential
Insights on the Formulation of Recombinant Proteins
Ribeiro, R., Abreu, T. R., Silva, A. C., Gonçalves, J., & Moreira, J. N. (2019) · Advances in biochemical engineering, biotechnology · doi:10.1007/10_2019_119 · Cited by 11
Recombinant Protein Production and Purification of Insoluble Proteins
Ferrer‐Miralles, N., Saccardo, P., Corchero, J. L., & García‐Fruitós, E. (2022) · Methods in molecular biology · doi:10.1007/978-1-0716-1859-2_1 · Cited by 7
Biopharmaceuticals Produced from Cultivated Mammalian Cells
Al‐Majmaie, R., Kuystermans, D., & Al‐Rubeai, M. (2021) · Cell engineering · doi:10.1007/978-3-030-79871-0_1 · Cited by 4
Expanding the Biotherapeutics Realm via miR-34a: "Potent Clever Little" Agent in Breast Cancer Therapy.
Mohammady, M., Ghetmiri, S. I., Baharizade, M., Morowvat, M. H., & Torabi, S. (2019) · Current Pharmaceutical Biotechnology · doi:10.2174/1389201020666190617162042 · Cited by 5
Yeast as a Model for Human Disease
Zieniuk, B., Wierzchowska, K., Jasińska, K., Kobus, J., Piotrowicz, A., Uğur, Ş., & Fabiszewska, A. U. (2026) · International Journal of Molecular Sciences · doi:10.3390/ijms27041632 · Cited by 5
“Compared with Chinese Hamster Ovary (CHO) cells, the current industry standard yeast offers faster growth, lower production costs, and scalability, making it a complementary platform for rapid and cost-effective drug manufacturing [172].”
Innovative bioseparation technologies employing thermoresponsive polymer interfaces
Nagase, K. (2025) · Polymer Journal · doi:10.1038/s41428-025-01117-6 · Cited by 3
High-throughput glycosylation screening method for biologics development using MALDI-TOF-MS
Zhang, W.-L., Xie, L., Zhao, H., Ma, X., & Ren, S. (2025) · Communications Chemistry · doi:10.1038/s42004-025-01680-2 · Cited by 4
Machine learning-enhanced 1NMR for rapid amino acid quantification in monoclonal antibody production
Shi, Y., Fang, K., Wu, S., Wan, Y., Jin, Y., Yang, J., Xie, X., Pan, J., Wang, H., & Qu, H. (2025) · European Journal of Pharmaceutical Sciences · doi:10.1016/j.ejps.2025.107356 · Cited by 4
Colloidal Stability Assessment of a Model Antibody Oligonucleotide Conjugate
Banks, D. D., & Cordia, J. F. (2025) · Molecular Pharmaceutics · doi:10.1021/acs.molpharmaceut.5c01126 · Cited by 4
Growth Factors and Cytokines for Regenerative Medicine: Translational Challenges and Emerging Engineering Solutions
Mohammadi, A., Heydari, M. A., & Jamalpoor, Z. (2025) · Regenerative Engineering and Translational Medicine · doi:10.1007/s40883-025-00458-1 · Cited by 5
“Bioengineering strategies have emerged to address these limitations [157, 158].”
Next-gen novel nanocage-based multivalent vaccine candidate to tackle the rising menace of Mpox
Ahuja, R., Vishwakarma, P., Kumar, V., Khatri, R., Chatterjee, A., Mishra, S., Rizvi, Z. A., Singh, A., Kaur, G., Maithil, V., et al. (2025) · npj Vaccines · doi:10.1038/s41541-025-01174-1 · Cited by 4
“Several functional proteins like growth hormone, interferon alpha 2b 58,59 extracellular domain PDL-1 60 , anti-PDL-1 single domain antibodies 61 , lysozyme, ovine growth hormone, yellow ﬂ uorescent protein and anti-cancer target MDM-2 62 have been recovered at a yield as high as 20 g/L 63 – 69 .”
The current status, trends, and developments in biopharmaceutical policy making in Iran
Safardoust, A., Ghanei, M., Mahboudi, F., Pourqasem, M., Mirmohammadi, S., & Moghadasian, M. (2025) · Journal of Science and Technology Policy Management · doi:10.1108/jstpm-01-2023-0009 · Cited by 4
Accelerating biopharmaceutical cell line selection with label-free multimodal nonlinear optical microscopy and machine learning
Shi, J., Ho, A., Snyder, C. E., Chaney, E. J., Sorrells, J. E., Alex, A., Talaban, R. V., Spillman, D. R., Marjanović, M., Doan, M., et al. (2025) · Communications Biology · doi:10.1038/s42003-025-07596-w · Cited by 7
“Among the available biopharmaceutical products, recombinant proteins, including monoclonal antibodies (mAbs), constitute a signi ﬁ cant share of these biotechnological medicines and rank as the highest-selling class 2 .”
Nanobody fusion enhances production of difficult-to-produce secretory proteins
Yan, R., Zhang, Y., Zhang, H., & Ma, J.-Y. (2025) · Journal of Biological Chemistry · doi:10.1016/j.jbc.2025.108292 · Cited by 4
“This pathway is extensively utilized in the biomedical ﬁ eld, including the production of bio-therapeutics by the pharmaceutical industry (2).”
Simple recombinant monoclonal antibody production from Escherichia coli
Baker, K., Eastwood, T. A., Garcia, E., Lennon, C., & Mulvihill, D. P. (2025) · Open Biology · doi:10.1098/rsob.240229 · Cited by 4
“Antibody fragments have been produced from E. coli through targeting the Fab peptide to the periplasmic region to allow the formation of the required disulfide bonds required for functional antibody complexes [1,3,4].”
Open Innovation and Regulatory Challenges in New Modality Development: The Pivotal Role of Contract Development and Manufacturing Organisations in Advancing Antibody Drugs
Yoshiura, H., Kawata, Y., & Sengoku, S. (2024) · Therapeutic Innovation and Regulatory Science · doi:10.1007/s43441-024-00701-x · Cited by 4
“The presence and importance of biopharmaceuticals have increased with the advancement of biotechnological technologies [1–3].”
A nanowell platform to identify, sort and expand high antibody-producing cells
Abali, F., Schasfoort, R., Nijland, S., Wittenberns, J., Tibbe, A., den Hartog, M., Boon, L., & Terstappen, L. W. M. M. (2024) · Scientific Reports · doi:10.1038/s41598-024-60054-1 · Cited by 4
In-Hydrogel Cell-Free Protein Expression System as Biocompatible and Implantable Biomaterial.
Sánchez-Costa, M., Urigoitia, A., Comino, N., Arnaiz, B., Khatami, N., Ruiz-Hernández, R., Diamanti, E., Abarrategi, A., & López-Gallego, F. (2024) · ACS Applied Materials and Interfaces · doi:10.1021/acsami.4c01388 · Cited by 4
Mitigating transcriptional bottleneck using a constitutively active transcription factor, VP16-CREB, in mammalian cells
Yoon, C., Baek, K. E., Kim, D., & Lee, G. M. (2023) · Metabolic Engineering · doi:10.1016/j.ymben.2023.09.005 · Cited by 4
Self-assembling and pH-responsive protein nanoparticle as potential platform for targeted tumor therapy
Xu, Z.-K., Zhang, X., Dong, W., Lv, H., Zuo, L.-J., Zhu, L., Wang, R.-N., & Ma, X. (2023) · Frontiers in Molecular Biosciences · doi:10.3389/fmolb.2023.1172100 · Cited by 4
“Protein therapeutics are drawing more and more attention because they are biodegradable, metabolizable, highly active and specific (Leader et al., 2008; Walsh, 2018).”
Background
Tuning metabolic efficiency for increased product yield in high titer fed‐batch Chinese hamster ovary cell culture
Helfer, A., Gros, S., Kolwyck, D., & Karst, D. J. (2023) · Biotechnology Progress · doi:10.1002/btpr.3327 · Cited by 5
“gene therapy and mRNA modalities.(1,2) CHO cells are of great interest for therapeutic protein production since their expression system can achieve high productivity while mimicking human-like post-translational modifications.”
Background
A New Expression System Based on Psychrotolerant Debaryomyces macquariensis Yeast and Its Application to the Production of Cold-Active β-d-Galactosidase from Paracoccus sp. 32d
Wanarska, M., Krajewska, E., Wicka-Grochocka, M., Cieśliński, H., Pawlak-Szukalska, A., Białkowska, A. M., Turkiewicz, M., Florczak, T., Gromek, E., Krysiak, J. M., et al. (2022) · International Journal of Molecular Sciences · doi:10.3390/ijms231911691 · Cited by 8
“It is still widely used in the production of biopharmaceuticals due to its GRAS status [18], although it has some disadvantages, e.”
Background
Disclosing the Potential of Fluorinated Ionic Liquids as Interferon-Alpha 2b Delivery Systems
Ferreira, M. L., Vieira, N. S. M., Oliveira, A. L. S., Araújo, J. M. M., & Pereiro, A. B. (2022) · Nanomaterials · doi:10.3390/nano12111851 · Cited by 4
“These compounds have contributed to the diagnosis and treatment of several diseases where conventional therapies have constantly failed, such as numerous cancers, immune and autoimmune infections and metabolic diseases, Alzheimer’s, HIV, and Parkinson’s, along with others [3,4].”
Background
Early-stage in silico flowsheet analysis for a monoclonal antibody platform
Kaiser, J., Babi, D. K., Pinelo, M., & Krühne, U. (2022) · Process Safety and Environmental Protection · doi:10.1016/j.cherd.2022.04.003 · Cited by 5
A Novel Potent Carrier for Unconventional Protein Export in Ustilago maydis
Philipp, M., Hussnaetter, K. P., Reindl, M., Müntjes, K., Feldbrügge, M., & Schipper, K. (2022) · Frontiers in Cell and Developmental Biology · doi:10.3389/fcell.2021.816335 · Cited by 4
“Keywords: luciferase, anti-Sars-CoV2 nanobody, unconventional secretion, Ustilago maydis, sybody INTRODUCTION Themarket for recombinant proteins like biopharmaceuticals is steadily increasing (Walsh 2018).”
Background
Sequence Effect of Peptide-Based Materials on Delivering Interferon-α (IFN-α): A Molecular Dynamic Perspective.
Liu, Y., Zhu, G.-L., Shen, Z., & Chen, Y.-T. (2022) · Langmuir · doi:10.1021/acs.langmuir.1c02515 · Cited by 4
Ethanol as additive enhances expression of Ranibizumab in Escherichia coli: Impact on cellular physiology and transcriptome
Priyanka, P., Patil, R. S., Meshram, P., Gupta, J. A., Banerjee, M., & Rathore, A. S. (2021) · Process Biochemistry · doi:10.1016/j.procbio.2021.11.029 · Cited by 6
A trivalent TNF‐R2 as a new tumor necrosis factor alpha‐blocking molecule
Contreras, M. A., Macaya, L., Suárez, V. M., Camacho, F., González, A., Montesinos, R., Toledo, J. R., & Sánchez, O. (2021) · Proteins Structure Function and Bioinformatics · doi:10.1002/prot.26177 · Cited by 4
“Previously, the obtention of a trivalent TNF-R2 using the C-propeptide domain of human type III procollagen as a trimerization domain was reported.24 There, the resulting protein presented superior characteristics when was compared with Etanercept, while 3cTNFR2 was similar to Etanercept.”
BackgroundInfluential
Stability of Protein Structure during Nanocarrier Encapsulation: Insights on Solvent Effects from Simulations and Spectroscopic Analysis
Markwalter, C. E., Uralcan, B., Pelczer, I., Zarzhitsky, S., Hecht, M. H., Prud’homme, R. K., & Debenedetti, P. G. (2020) · ACS Nano · doi:10.1021/acsnano.0c06056 · Cited by 4
Development of recombinant human granulocyte colony-stimulating factor (nartograstim) production process in Escherichia coli compatible with industrial scale and with no antibiotics in the culture medium
Eguia, F. A. P., Mascarelli, D., Carvalho, E., Rodríguez, G. R., Makiyama, E., Borelli, P., Lieberman, C., Ho, P., Barazzone, G., & Gonçalves, V. M. (2020) · Applied Microbiology and Biotechnology · doi:10.1007/s00253-020-11014-y · Cited by 4
Characterization of Affitin proteolytic digestion in biorelevant media and improvement of their stabilities via protein engineering
Loussouarn, A., Béhar, G., Pecorari, F., Croyal, M., & Renodon-Cornière, A. (2020) · Scientific Reports · doi:10.1038/s41598-020-76855-z · Cited by 4
Application of Genetic Engineering in Biotherapeutics Development
Schweickert, P. G., & Cheng, Z. (2019) · Journal of Pharmaceutical Innovation · doi:10.1007/s12247-019-09411-6 · Cited by 8
“Because of these advantages, the majority of biotherapeutics produced today are generated using CHO cells [47], with monoclonal antibodies (mAb) being the largest manufacturing focus [48].”
Background
Protein crystallisation with gas microbubbles as soft template in a microfluidic device
Tian, W.-Q., Ogunyinka, O., Oretti, C., Bandulasena, H. C. H., Rielly, C., & Yang, H. (2023) · Molecular Systems Design & Engineering · doi:10.1039/d3me00058c · Cited by 4

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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