Quality by Design: Industrial Case Studies on Defining and Implementing Design Space for Pharmaceutical Processes (Part 2) - Understanding the relationship between the process and CQAs. - BioPharm

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Quality by Design: Industrial Case Studies on Defining and Implementing Design Space for Pharmaceutical Processes (Part 2)
Understanding the relationship between the process and CQAs.


BioPharm International
Volume 22, Issue 1

REFERENCES

1. US Food and Drug Administration. 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. Gnoth S, Jenzsch M, Simutis R, Lübbert A. Process analytical technology (PAT): batch-to-batch reproducibility of fermentation processes by robust process operational design and control. J Biotechnol. 2007;132:180–6.

4. Kirdar AO, Conner JS, Baclaski J, Rathore AS. Application of multivariate analysis towards biotech processes: Case study of a cell-culture unit operation. Biotech Prog. 2007;23:61–7.

5. Johnson R, Yu O, Kirdar AO, Annamalai A, Ahuja S, Ram K, Rathore, AS. Applications of multivariate data analysis (MVDA) for biotech processing. BioPharm Int. 2007 Oct;20(10):130–44.

6. Kirdar AO, Green KD, Rathore AS. Application of multivariate analysis for identification and resolution of a root cause for a bioprocessing application. Biotech Prog. 2008;24:720–6.

7. Rathore AS, Sharma A, Chillin D. Applying process analytical technology to biotech unit operations. BioPharm Int. 2006 Aug; 19(8):48–57.

8. Rathore AS, Yu M, Yeboah S, Sharma A. Case study and application of process analytical technology (PAT) towards bioprocessing: use of on-line high performance liquid chromatography (HPLC) for making real time pooling decisions for process chromatography. Biotechnol Bioeng. 2008;100:306–16.

9. Rathore AS, Branning R, Cecchini D. Design space for biotech products. BioPharm Intl. 2007 April;20(4):36–40.

10. US FDA. Guidance for Industry: Q10 quality systems approach to pharmaceutical CGMP regulations. Rockville, MD: 2006 Sept.

11. Kozlowski S, Swann P. Current and future issues in the manufacturing and development of monoclonal antibodies. Adv Drug Deliv Rev. 2006;58:707–22.

12. 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;24:655–62.

13. Yu LX, Lionberger RA, Raw AS, D'Costa R, Wu H, Hussain AS. Applications of process analytical technology to crystallization process. Adv Drug Deliv Rev. 2004;56:349–69.


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