Quality by Design: Industrial Case Studies on Defining and Implementing Design Space for Pharmaceutical Processes—Part 1 - How to use multivariate experiments to define acceptable ranges. - BioP

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Quality by Design: Industrial Case Studies on Defining and Implementing Design Space for Pharmaceutical Processes—Part 1
How to use multivariate experiments to define acceptable ranges.


BioPharm International
Volume 21, Issue 12

REFERENCES

1. US Food and Drug Administration (FDA). Guidance for Industry. Q8, Pharmaceutical Development. Rockville, MD; 2006 May.

2. US FDA. PAT Guidance for Industry—A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance. Rockville, MD; 2004 Sept.

3. US FDA. Guidance for Industry. Q9 Quality Risk Management. Rockville, MD; 2006 June.

4. Nail SL, Searles JA. Elements of quality by design in development and scale-up of freeze-dried parenterals. BioPharm Int. 2008 Jan;21(1):44-52.

5. Cook S, Patton KA, Bazemore LR. Quality by design in the CMO environment. BioPharm Int. 2007 Dec;20(12):28-37.

6. Harms J, Wang X, Kim T, Yang J, Rathore AS. Defining design space for biotech products: case study of Pichia pastoris fermentation. Biotechnol Prog. 2008;24:655-662.

7. Rathore AS, Branning R, Cecchini D. Design space for biotech products. BioPharm Intl. 2007 April;20(5):36-40.

8. Seely J. Process Characterization. In: Rathore AS, Sofer G, editors. Process Validation in Manufacturing of Biopharmaceuticals. Boca Raton, FL: Taylor & Francis; 2005. p. 31-68.

9. Seely RJ, Haury J. Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes. In Rathore AS, Sofer G, editors. Process Validation in Manufacturing of Biopharmaceuticals. Boca Raton, FL: Taylor & Francis; 2005. p. 13-30.


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