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Immunogenicity of biopharmaceuticals
Open accessAbstract
The availability of biopharmaceuticals has been increasing over the past decade and as their patents expire, the emergence of biosimilar agents approaches. The primary issue of concern for the safety of these agents is the potential for immunogenicity. Both product- and host-related factors have documented impact on the immune response, but many factors are still unknown. Although in many cases the presence of antibodies may have little clinical consequence, the upsurge of pure red cell aplasia cases further increased concerns about potential clinical consequences of extensive use of biopharmaceuticals and biosimilars. Available laboratory measurement methods are insufficient to predict biological and clinical properties of biopharmaceuticals, or even to compare their bioequivalence. Comparison of results from different studies is complicated by the variability of assay measurements, presentation of data and lack of standardization.
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Cited by
Progress in biopharmaceutical development
Kesik‐Brodacka, M. (2018) · Biotechnology and Applied Biochemistry · doi:10.1002/bab.1617 · Cited by 353
O’Flaherty, R., Bergin, A., Flampouri, E., Mota, L. M., Obaidi, I., Quigley, A., Xie, Y., & Butler, M. (2020) · Biotechnology Advances · doi:10.1016/j.biotechadv.2020.107552 · Cited by 277
Carpenter, J. F., Randolph, T. W., Jiskoot, W., Crommelin, D. J. A., Middaugh, C. R., & Winter, G. (2010) · Journal of Pharmaceutical Sciences · doi:10.1002/jps.21989 · Cited by 202
Prediction of aggregation prone regions of therapeutic proteins
Chennamsetty, N., Voynov, V., Kayser, V., Helk, B., & Trout, B. L. (2010) · The Journal of Physical Chemistry B · doi:10.1021/jp911706q · Cited by 200
Hulse, W. L., Gray, J., & Forbes, R. T. (2013) · International Journal of Pharmaceutics · doi:10.1016/j.ijpharm.2013.05.062 · Cited by 31
Metadata
- Authors
- Kessler, M., Goldsmith, D., & Schellekens, H.
- Venue
- Nephrology Dialysis Transplantation
- Publisher
- Oxford University Press (OUP)
- Published
- 2006-10-01
- Volume
- 21
- Issue
- suppl_5
- Pages
- v9-v12
- ISSN
- 0931-0509 (ISSN-L)
- 1460-2385
- OpenAlex
- W2110270840
- Cited by
- 209
- References
- 0
- FWCI
- 4.97
- Type
- journal article
- Language
- en
- Open access
- bronze
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
