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

ADVERTISEMENT

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).


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

First Biosimilar Application Kicks Off Legal Battle
October 31, 2014
FDA Approves Pfizer's Trumenba for the Prevention of Meningitis B
October 30, 2014
EMA: Extrapolation Across Indications for Biosimilars a Possibility
October 30, 2014
Bristol-Myers Squibb Announces Agreement to Acquire HER2-Targeted Cancer Treatment
October 29, 2014
Amgen, Sanofi, and Ono Pharmaceuticals Partner with Universities on Transmembrane Protein Research
October 28, 2014
Author Guidelines
Source: BioPharm International Supplements,
Click here