Cited by 107Protein purification and stabilityMonoclonal and Polyclonal Antibodies Researchvaccines and immunoinformatics approaches

Aggregation risk prediction for antibodies and its application to biotherapeutic development

Open access
Obrezanova, Olga, Arnell, Andreas, de la Cuesta, Ramón Gómez, Berthelot, Maud E, Gallagher, Thomas RA, Zurdo, Jesús, Stallwood, Yvette·2015·mAbs

Abstract

Aggregation is a common problem affecting biopharmaceutical development that can have a significant effect on the quality of the product, as well as the safety to patients, particularly because of the increased risk of immune reactions. Here, we describe a new high-throughput screening algorithm developed to classify antibody molecules based on their propensity to aggregate. The tool, constructed and validated on experimental aggregation data for over 500 antibodies, is able to discern molecules with a high aggregation propensity as defined by experimental criteria relevant to bioprocessing and manufacturing of these molecules. Furthermore, we show how this tool can be combined with other computational approaches during early drug development to select molecules with reduced risk of aggregation and optimal developability properties.

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Crossref · 10.1080/19420862.2015.1007828

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References 32 · Cited by 107

Research works printed but not linked: 3

  1. [12]Zurdo J, Michael R, Stallwood Y, Hedman K, Aastrup T Improving the developability of biopharmaceuticals. Inno Pharma Technol 2011; 37: 34- 40.
  2. [25]Lonza Biologics Epibase™ Immunogenicity Assessment Page [Internet]. Cambridge, UK: Lonza Biologics; 2014 [cited 2014 Oct 7] Available from: http://www.lonza.com/custom-manufacturing/development-technologies/protein-and-vaccine-development-services/immunogenicity-platforms.aspx
  3. [28]Zurdo J Surviving the valley of death. Eur Biopharmaceutical Rev 2013; 195: 50- 4.

Authors
Obrezanova, O., Arnell, A., de la Cuesta, R. G., Berthelot, M. E., Gallagher, T. R., Zurdo, J., & Stallwood, Y.
Affiliations
Lonza (United Kingdom) (GB)
Corresponding author
Obrezanova, Olga
Venue
mAbs
Published
2015-03-04
Volume
7
Issue
2
Pages
352-363
ISSN
  • 1942-0862 (ISSN-L)
  • 1942-0870
OpenAlex
W1516451386
Cited by
107
References
32
Citations by year
2026: 6 · 2025: 6 · 2024: 11 · 2023: 8 · 2022: 9 · 2021: 12 · 2020: 14 · 2019: 13 · 2018: 11 · 2017: 11 · 2016: 3 · 2015: 3
FWCI
4.05
Type
journal article
Language
en
Open access
Licence
cc-by-nc
Locations
  • mAbs (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
Topics
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Protein purification and stability
  • Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › vaccines and immunoinformatics approaches
Keywords
antibody aggregation, high-throughput screening, biologic therapy, developability, biopharmaceutical quality, bioprocessing, early drug development, computational screening
MeSH terms
Algorithms, Antibodies, Humans, Protein Aggregates

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