The DOI matches its Crossref record; 322 of the 322 references it cites were found in a registry or an index.
Structure, heterogeneity and developability assessment of therapeutic antibodies
Open accessAbstract
Increasing attention has been paid to developability assessment with the understanding that thorough evaluation of monoclonal antibody lead candidates at an early stage can avoid delays during late-stage development. The concept of developability is based on the knowledge gained from the successful development of approximately 80 marketed antibody and Fc-fusion protein drug products and from the lessons learned from many failed development programs over the last three decades. Here, we reviewed antibody quality attributes that are critical to development and traditional and state-of-the-art analytical methods to monitor those attributes. Based on our collective experiences, a practical workflow is proposed as a best practice for developability assessment including in silico evaluation, extended characterization and forced degradation using appropriate analytical methods that allow characterization with limited material consumption and fast turnaround time.
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Cites
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Strategies and challenges for the next generation of therapeutic antibodies
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Self-citationNext generation antibody drugs: pursuit of the 'high-hanging fruit'
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Biophysical properties of the clinical-stage antibody landscape
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“Besides aggregation, mAbs with lower thermal stability have been shown to have lower expression.(73,207) Thermal stability has been commonly measured by differential scanning calorimetry (DSC).”
BackgroundSelf-citationDesign of therapeutic proteins with enhanced stability
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Cited by
Predicting antibody developability profiles through early stage discovery screening
Bailly, M., Mieczkowski, C., Juan, V., Metwally, E., Tomazela, D., Baker, J., Uchida, M., Kofman, E., Raoufi, F., Motlagh, S., et al. (2020) · mAbs · doi:10.1080/19420862.2020.1743053 · Cited by 228
Self-citationLai, P.-K., Gallegos, A., Mody, N., Sathish, H. A., & Trout, B. L. (2022) · mAbs · doi:10.1080/19420862.2022.2026208 · Cited by 103
Sawyer, W. S., Srikumar, N., Carver, J., Chu, P. Y., Shen, A., Xu, A., Williams, A. J., Spiess, C., Wu, C., Liu, Y., et al. (2020) · Proceedings of the National Academy of Sciences · doi:10.1073/pnas.1917383117 · Cited by 55
Bashour, H., Smorodina, E., Pariset, M., Zhong, J., Akbar, R., Chernigovskaya, M., Lê Quý, K., Snapkow, I., Rawat, P., Krawczyk, K., et al. (2024) · Communications Biology · doi:10.1038/s42003-024-06561-3 · Cited by 32
The therapeutic antibody profiler for computational developability assessment
Raybould, M. I. J., & Deane, C. M. (2022) · Methods in molecular biology · doi:10.1007/978-1-0716-1450-1_5 · Cited by 25
Metadata
- Authors
- Xu, Y., Wang, D., Mason, B., Rossomando, T., Li, N., Liu, D., Cheung, J. K., Xu, W., Raghava, S., Katiyar, A., Nowak, C., Xiang, T., Dong, D. D., Sun, J., Beck, A., & Liu, H.
- Venue
- mAbs
- Publisher
- Informa UK Limited
- Published
- 2018-12-17
- Volume
- 11
- Issue
- 2
- Pages
- 239-264
- ISSN
- 1942-0862 (ISSN-L)
- 1942-0870
- OpenAlex
- W2904971004
- Cited by
- 264
- References
- 322
- FWCI
- 7.53
- Type
- journal article
- Language
- en
- Open access
- gold
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- Xu, Y., Wang, D., Mason, B., Rossomando, T., Li, N., Liu, D., Cheung, J. K., Xu, W., Raghava, S., Katiyar, A., Nowak, C., Xiang, T., Dong, D. D., Sun, J., Beck, A., & Liu, H. (2019). Structure, heterogeneity and developability assessment of therapeutic antibodies. mAbs. https://doi.org/10.1080/19420862.2018.1553476
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