Cited by 242Monoclonal and Polyclonal Antibodies ResearchProtein purification and stabilityBiosimilars and Bioanalytical Methods

Developability Assessment During the Selection of Novel Therapeutic Antibodies

Jarasch, Alexander, Koll, Hans, Regula, Joerg T., Bader, Martin, Papadimitriou, Apollon, Kettenberger, Hubert·2015·Journal of Pharmaceutical Sciences

Abstract

Therapeutic antibodies and antibody derivatives comprise the majority of today's biotherapeutics. Routine methods to generate novel antibodies, such as immunization and phage-display, often give rise to several candidates with desired functional properties. On the contrary, resource-intense steps such as the development of a cell line, a manufacturing process, or a formulation, are typically carried out for only one candidate. Therefore, "developability," that is, the likelihood for the successful development of a lead candidate into a stable, manufacturable, safe, and efficacious drug, may be used as an additional selection criterion. Employing a set of small-scale, fast, and predictive tests addressing biochemical and biophysical features, as well as in vivo fate can help to identify a clinical candidate molecule with promising properties at an early stage of drug development. This article gives an overview of existing methods for developability testing and shows how these assays can be interlaced in the lead selection process.

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Crossref · 10.1002/jps.24430

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Authors
Jarasch, A., Koll, H., Regula, J. T., Bader, M., Papadimitriou, A., & Kettenberger, H.
Affiliations
Roche Pharma AG (Germany) (DE)
Corresponding author
Kettenberger, Hubert
Venue
Journal of Pharmaceutical Sciences
Publisher
Elsevier BV
Published
2015-06
Volume
104
Issue
6
Pages
1885-1898
ISSN
0022-3549 (ISSN-L)
OpenAlex
W2035589414
Cited by
242
References
136
Citations by year
2026: 15 · 2025: 22 · 2024: 19 · 2023: 27 · 2022: 29 · 2021: 32 · 2020: 21 · 2019: 29 · 2018: 17 · 2017: 20 · 2016: 9 · 2015: 2
FWCI
2.55
Type
journal article
Language
en
Open access
closed
Locations
  • Journal of Pharmaceutical Sciences (publishedVersion)
  • PubMed (publishedVersion)
Funders
Roche
Topics
  • Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Protein purification and stability
  • Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
Keywords
developability assessment, therapeutic antibodies, antibody selection, lead candidate selection, biologic therapy, antibody stability, manufacturability, in vivo fate, early drug development, predictive assays
MeSH terms
Animals, Antibodies, Monoclonal, Glycosylation, Humans, Models, Molecular, Protein Conformation, Protein Stability, Drug Discovery

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