Quality-by-Design is a systematic, risk-based framework for biopharmaceutical development that integrates predefined product quality targets with deliberate, concurrent optimization of process parameters and material attributes to ensure consistent, reproducible manufacturing performance and product quality.
293
Publications
14.5K
Citations
1.2K
Authors
390
Institutions
Publications per year
2017–2026
155
Publications
293
Quality by design for biopharmaceuticals
Anurag S. Rathore, Helen Winkle · Nature Biotechnology · 2009 · 796 citations
Quality by Design in Biopharmaceuticals
Harry Yang · 2016 · 545 citations
1–5 of 293
Authors
1.2K
- AS
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5
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Institutions
390
Pfizer (United States)
New York, United States
11 h-index
26 publications
1.4K citations
United States Food and Drug Administration
Silver Spring, United States
7 h-index
21 publications
4.4K citations
Center for Drug Evaluation and Research
Silver Spring, United States
7 h-index
18 publications
2.3K citations
University of Copenhagen
Copenhagen, Denmark
6 h-index
25 publications
1.1K citations
Purdue University West Lafayette
West Lafayette, United States
6 h-index
22 publications
983 citations
Indian Institute of Technology Delhi
New Delhi, India
6 h-index
15 publications
643 citations
Rede de Química e Tecnologia
Porto, Portugal
6 h-index
14 publications
537 citations
Centre National de la Recherche Scientifique
Paris, France
6 h-index
16 publications
496 citations
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Venues
- Pharmaceutics
16 publications · 357 citations
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- Journal of Pharmaceutical and Biomedical Analysis
12 publications · 620 citations
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- International Journal of Pharmaceutics
10 publications · 850 citations
12
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- Journal of Pharmaceutical Sciences
11 publications · 510 citations
11
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- Organic Process Research & Development
10 publications · 439 citations
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