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Cited by 481Monoclonal and Polyclonal Antibodies ResearchBiosimilars and Bioanalytical MethodsProtein purification and stability

Recent advances in (therapeutic protein) drug development

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Lagassé, H.A. Daniel, Alexaki, Aikaterini, Simhadri, Vijaya L., Katagiri, Nobuko H., Jankowski, Wojciech, Sauna, Zuben E., Kimchi-Sarfaty, Chava·2017·F1000Research
DOI 10.12688/f1000research.9970.1PMC PMC5302153
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Abstract

Therapeutic protein drugs are an important class of medicines serving patients most in need of novel therapies. Recently approved recombinant protein therapeutics have been developed to treat a wide variety of clinical indications, including cancers, autoimmunity/inflammation, exposure to infectious agents, and genetic disorders. The latest advances in protein-engineering technologies have allowed drug developers and manufacturers to fine-tune and exploit desirable functional characteristics of proteins of interest while maintaining (and in some cases enhancing) product safety or efficacy or both. In this review, we highlight the emerging trends and approaches in protein drug development by using examples of therapeutic proteins approved by the U.S. Food and Drug Administration over the previous five years (2011–2016, namely January 1, 2011, through August 31, 2016).

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  • With such high-expression yields in flasks, production of antibody fragments would not require scale-up to bioreactors during drug development.

    “With such high-expression yields in the flasks, the production of antibody fragments would not require a scale-up to bioreactors during the drug development process [129].”

    From Evolution of Escherichia coli Expression System in Producing Antibody Recombinant Fragments (2020) · cites this paper as [129]

    The Protein engineering section discusses the complexity of therapeutic-protein manufacturing, but does not address antibody-fragment yields in flasks or whether those yields eliminate bioreactor scale-up. Searches for those terms and for flask production without scale-up found no passage supporting the claim; page numbers were not available in our copy. (LLM, conf=0.72)

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Cited by

Sorted by citations

Authors
Lagassé, H. A. D., Alexaki, A., Simhadri, V. L., Katagiri, N. H., Jankowski, W., Sauna, Z. E., & Kimchi-Sarfaty, C.
Affiliations
Center for Biologics Evaluation and Research (US)
Corresponding author
Sauna, Zuben E.
ORCID
Venue
F1000Research
Publisher
F1000 Research Ltd
Published
2017-02-07
Volume
6
Pages
113
ISSN
2046-1402 (ISSN-L)
DOI
10.12688/f1000research.9970.1
PMC
PMC5302153
OpenAlex
W2586724023
Cited by
481
References
1
Citations by year
2026: 17 · 2025: 38 · 2024: 64 · 2023: 57 · 2022: 60 · 2021: 59 · 2020: 72 · 2019: 64 · 2018: 45 · 2017: 5
FWCI
7.74
Type
journal article
Language
en
Open access
Licence
Locations
  • F1000Research (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Topics
  • Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
  • Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Protein purification and stability
Keywords
therapeutic proteins, recombinant therapeutic proteins, protein engineering, FDA-approved drugs, drug development, cancer therapy, infectious disease exposure, genetic disorders

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