When the Process Becomes the Product: Single-Use Technology and the Next Biomanufacturing Paradigm - The move to single-use manufacturing has prompted a paradigm shift in facility design. - BioPharm

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When the Process Becomes the Product: Single-Use Technology and the Next Biomanufacturing Paradigm
The move to single-use manufacturing has prompted a paradigm shift in facility design.


BioPharm International Supplements
Volume 26, Issue 4, pp. s27-s30

REFERENCES

1. G. Köhler and C. Milstein, Nature 256, 495-497 (1975).

2. J.M. Walker, Methods in Molecular Biology, (Springer).

3. FACTBOX-World's Top-Selling Drugs in 2014 vs 2010, http://www.reuters.com/article/2010/04/13/roche-avastin-drugs-idUSLDE63C0BC20100413/, accessed March 11, 2013.

4. A. Sinclair, BioPharm Intl. 21 (6), 26-30 (2008).

5. A. Foulon et al., BioProcess Intl. 6 (6), 12-17 (2008).

6. A. Ravisé et al., Biochem. Eng.Biotechnol. 115, 185-219 (2010).

7. A. Koch, et al., American Pharmaceutical Review, Nov-Dec issue (2006).

8. Code of Federal Regulations, Title 211, Current Good Manufacturing Practice for Finished Pharmaceuticals, Part 42 (Govern-ment Printing Office, Washington, DC).

9. A. Luitjens and A. Pralong (2011). Going Fully Disposable – Current Possibilities: A Case Study from Crucell, Single-use Technology, in Biopharmaceutical Manufacturing (Wiley, 2009) pp. 341-349.

10. A. Luitjens, J.Lewis, and A. Pralong (2012). Single-Use Biotechnologies and Modular Manufacturing Environments Invite Paradigm Shifts, in Bioprocess Development and Biopharmaceutical Manufacturing, Biopharmaceutical Production Technology, (Wiley, 2012) pp. 817-857.

11. FDA, Guidance for Industry: Process Validation: General Principles and Practices (Rockville, MD, 2011)

12. FDA, Guidance for Industry: PAT —A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance (Rockville, MD, 2004).


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