The DOI matches its Crossref record; 10 of the 10 references it cites were found in a registry or an index.
Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars
Open accessAbstract
Biologics such as monoclonal antibodies are much more complex than small-molecule drugs, which raises challenging questions for the development and regulatory evaluation of follow-on versions of such biopharmaceutical products (also known as biosimilars) and their clinical use once patent protection for the pioneering biologic has expired. With the recent introduction of regulatory pathways for follow-on versions of complex biologics, the role of analytical technologies in comparing biosimilars with the corresponding reference product is attracting substantial interest in establishing the development requirements for biosimilars. Here, we discuss the current state of the art in analytical technologies to assess three characteristics of protein biopharmaceuticals that regulatory authorities have identified as being important in development strategies for biosimilars: post-translational modifications, three-dimensional structures and protein aggregation.
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Cites
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Cited by
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Self-citationToward Biotherapeutic Product Real‐Time Quality Monitoring
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The molecular basis for hydrodynamic properties of PEGylated human serum albumin
(2024) · doi:10.1016/j.bpj.2024.05.019 · Cited by 9
Metadata
- Authors
- Berkowitz, S. A., Engen, J. R., Mazzeo, J. R., & Jones, G. B.
- Venue
- Nature Reviews Drug Discovery
- Published
- 2012-06-29
- Volume
- 11
- Issue
- 7
- Pages
- 527-540
- ISSN
- 1474-1776 (ISSN-L)
- 1474-1784
- OpenAlex
- W1971014721
- Cited by
- 529
- References
- 10
- FWCI
- 2.77
- Type
- journal article
- Language
- en
- Open access
- green
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- Berkowitz, S. A., Engen, J. R., Mazzeo, J. R., & Jones, G. B. (2012). Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars. Nature Reviews Drug Discovery. https://doi.org/10.1038/nrd3746
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