The DOI matches its Crossref record; 10 of the 10 references it cites were found in a registry or an index.
Quality by design for biopharmaceuticals
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Citations
Cites
Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control
Yu, L. X. (2008) · Pharmaceutical Research · doi:10.1007/s11095-007-9511-1 · Cited by 1,191
Mire-Sluis, A. R., Barrett, Y. C., Devanarayan, V., Koren, E., Liu, H., Maia, M., Parish, T., Scott, G., Shankar, G., Shores, E., et al. (2004) · Journal of Immunological Methods · doi:10.1016/j.jim.2004.06.002 · Cited by 624
Applications of process analytical technology to crystallization processes
Yu, L. (2004) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2003.10.012 · Cited by 323
Gupta, S., Indelicato, S. R., Jethwa, V., Kawabata, T., Kelley, M., Mire-Sluis, A. R., Richards, S. M., Rup, B., Shores, E., Swanson, S. J., et al. (2007) · Journal of Immunological Methods · doi:10.1016/j.jim.2006.12.004 · Cited by 241
Current and future issues in the manufacturing and development of monoclonal antibodies
Kozlowski, S., & Swann, P. (2006) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2006.05.002 · Cited by 170
Gnoth, S., Jenzsch, M., Simutis, R., & Lübbert, A. (2007) · Journal of Biotechnology · doi:10.1016/j.jbiotec.2007.03.020 · Cited by 127
Rathore, A. S., Yu, M., Yeboah, S., & Sharma, A. (2007) · Biotechnology and Bioengineering · doi:10.1002/bit.21759 · Cited by 126
Self-citationDefining Process Design Space for Biotech Products: Case Study of Pichia pastoris Fermentation
Harms, J., Wang, X., Kim, T., Yang, X., & Rathore, A. S. (2008) · Biotechnology Progress · doi:10.1021/bp070338y · Cited by 101
Self-citationKirdar, A. O., Conner, J. S., Baclaski, J., & Rathore, A. S. (2007) · Biotechnology Progress · doi:10.1021/bp060377u · Cited by 99
Self-citationKirdar, A. O., Green, K. D., & Rathore, A. S. (2008) · Biotechnology Progress · doi:10.1021/bp0704384 · Cited by 97
Self-citation
Cited by
Understanding pharmaceutical quality by design
Yu, L. X., Amidon, G., Khan, M. A., Hoag, S. W., Polli, J., Raju, G. K., & Woodcock, J. (2014) · The AAPS Journal · doi:10.1208/s12248-014-9598-3 · Cited by 1,475
Current hurdles to the translation of nanomedicines from bench to the clinic
Đorđević, S., Gonzalez, M. M., Conejos-Sánchez, I., Carreira, B., Pozzi, S., Acúrcio, R. C., Satchi-Fainaro, R., Florindo, H. F., & Vicent, M. J. (2022) · Drug Delivery and Translational Research · doi:10.1007/s13346-021-01024-2 · Cited by 657
Clinical manufacturing of CAR T cells: foundation of a promising therapy
Wang, X., & Rivière, I. (2016) · Molecular Therapy - Oncolytics · doi:10.1038/mto.2016.15 · Cited by 637
Roadmap for implementation of quality by design (QbD) for biotechnology products
Rathore, A. S. (2009) · Trends in Biotechnology · doi:10.1016/j.tibtech.2009.06.006 · Cited by 411
Self-citationPandi, P., Bulusu, R., Kommineni, N., Khan, W., & Singh, M. (2020) · International Journal of Pharmaceutics · doi:10.1016/j.ijpharm.2020.119560 · Cited by 391
Metadata
- Authors
- Rathore, A. S., & Winkle, H.
- Venue
- Nature Biotechnology
- Published
- 2009-01
- Volume
- 27
- Issue
- 1
- Pages
- 26-34
- ISSN
- 0733-222X (ISSN-L)
- 1087-0156
- 1546-1696
- OpenAlex
- W2077285487
- Cited by
- 830
- References
- 10
- FWCI
- 13.44
- Type
- journal article
- Language
- en
- Open access
- closed
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
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How to cite
Cite CoChat for the checks on this page, and the paper for its own findings.
- This page
- CoChat. (2026). Citation check: Quality by design for biopharmaceuticals. https://app.cochat.ai/papers/10.1038/nbt0109-26
- The paper
- Rathore, A. S., & Winkle, H. (2009). Quality by design for biopharmaceuticals. Nature Biotechnology. https://doi.org/10.1038/nbt0109-26
Data sources
Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
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.
