Implementation of QbD for Manufacturing of Biologics—Has It Met the Expectations?
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Elsevier
Reference124 articles.
1. Quality by design for biopharmaceuticals;Rathore;Nat. Biotechnol.,2009
2. Roadmap for implementation of quality by design (QbD) for biotechnology products;Rathore;Trends Biotechnol.,2009
3. Design of experiments applications in bioprocessing: concepts and approach;Kumar;Biotechnol. Prog.,2014
4. Challenges of glycosylation analysis and control: an integrated approach to producing optimal and consistent therapeutic drugs;Zhang;Drug Discov. Today,2016
5. Application of Simplex-based experimental optimisation to challenging bioprocess development problems: case studies in downstream processing;Konstantinidis;Biotechnol. Prog.,2016
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