The DOI matches its Crossref record; 1 of the 1 references it cites were found in a registry or an index.
Process analytical technology (PAT) for biopharmaceutical products: Part I. concepts and applications
Abstract
Process analytical technology (PAT) has been gaining momentum in the biotech community due to the potential for continuous real‐time quality assurance resulting in improved operational control and compliance. In this two part series, we address PAT as it applies to processes that produce biotech therapeutic products. In the first part, we address evolution of the underlying concepts and applications in biopharmaceutical manufacturing. We also present a literature review of applications in the areas of upstream and downstream processing to illustrate how implementation of PAT can help realize advanced approaches to ensuring product quality in real time. In the second part, we will explore similar applications in the areas of drug product manufacturing, rapid microbiology, and chemometrics as well as evolution of PAT in biotech processing. Biotechnol. Bioeng. 2010; 105: 276–284. Published 2009 Wiley Periodicals, Inc.
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Cites
Bioprocess optimization using design-of-experiments methodology
Mandenius, C., & Brundin, A. (2008) · Biotechnology Progress · doi:10.1002/btpr.67 · Cited by 422
Cited by
Process analytical technology (PAT) for biopharmaceutical products
Rathore, A. S., Bhambure, R., & Ghare, V. (2010) · Analytical and Bioanalytical Chemistry · doi:10.1007/s00216-010-3781-x · Cited by 368
Self-citationO’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
Refolding of proteins from inclusion bodies: rational design and recipes
Basu, A., Li, X., & Leong, S. S. J. (2011) · Applied Microbiology and Biotechnology · doi:10.1007/s00253-011-3513-y · Cited by 79
Feidl, F., Garbellini, S., Luna, M. F., Vogg, S., Souquet, J., Broly, H., Morbidelli, M., & Butté, A. (2019) · Processes · doi:10.3390/pr7100683 · Cited by 46
Wasalathanthri, D. P., Feroz, H., Puri, N., Hung, J., Lane, G., Holstein, M., Chemmalil, L., Both, D., Ghose, S., Ding, J., et al. (2020) · Biotechnology and Bioengineering · doi:10.1002/bit.27532 · Cited by 38
Cell culture media analysis using rapid spectroscopic methods
Ryder, A. G. (2018) · Current Opinion in Chemical Engineering · doi:10.1016/j.coche.2018.08.008 · Cited by 30
Process analytics 4.0: A paradigm shift in rapid analytics for biologics development
Wasalathanthri, D. P., Shah, R., Ding, J., Leone, A., & Li, Z. J. (2021) · Biotechnology Progress · doi:10.1002/btpr.3177 · Cited by 17
Self-citationWestwood, F., Ponstingl, M., & Dickens, J. E. (2024) · Journal of Pharmaceutical and Biomedical Analysis · doi:10.1016/j.jpba.2024.115965 · Cited by 4
Metadata
- Authors
- Read, E. K., Park, J. T., Shah, R. B., Riley, B. S., Brorson, K. A., & Rathore, A. S.
- Venue
- Biotechnology and Bioengineering
- Publisher
- Wiley
- Published
- 2009-10-20
- Volume
- 105
- Issue
- 2
- Pages
- 276-284
- ISSN
- 0006-3592 (ISSN-L)
- 1097-0290
- OpenAlex
- W4241141797
- Cited by
- 217
- References
- 1
- FWCI
- 3.48
- Type
- journal article
- Language
- en
- Open access
- closed
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