Tools for Enabling Process Analytical Technology Applications in Biotechnology - The authors review the various analytical methods that can enable use of PAT - BioPharm International

ADVERTISEMENT

Tools for Enabling Process Analytical Technology Applications in Biotechnology
The authors review the various analytical methods that can enable use of PAT


BioPharm International
Volume 25, Issue 8, pp. 27-35

REFERENCES

1. FDA, PAT Guidance for Industry— A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance, September, (2004).

2. E.K. Read et al., Biotechnol. Bioengin. 105, 276–284 (2010).

3. E.K. Read et al, Biotechnol. Bioengin. 105, 285–295 (2010).

4. A.S. Rathore and H. Winkle, Nat. Biotechnol. 27, 26–34 (2009).

5. A.S. Rathore, R. Bhambure, and V. Ghare, Anal. Bioanal. Chem. 398, 137–154 (2010).

6. W.F. McClure et al., Near-Infrared Technology in the Agricultural and Food Industries, 2, 145–169 (2001).

7. Handbook of Near-Infrared Analysis, D.A. Burns and E.W. Ciurczak, Eds. (CRC Press, Taylor & Francis Group, Boca Raton, Florida, 2001) 22, 573–575.

8. M. Roman Balabin, Z. Ravilya Safieva, and I. Ekaterina Lomakina, Chemometr. Intell. Lab 2, 183–188 (2007).

9. A.O. Kirdar, G. Chen, and A.S. Rathore, Biotechnol. Prog. 26, 527–531 (2010).

10. S. Gnoth, M. Jenzsch, R. Simutis, and A. Lubbert, J. Biotechnol. 132, 180–186 (2007).

11. X. Lawrence Yu et al, Advan. Drug Del. Rev. 56, 349–369 (2004).

12. C. Dirk Hinz, Anal. and Bioanal. Chem. 384, 1036–1042 (2006).

13. P.J. Treado and M.D. Morris, Prac. Spectros. Series 16, (1993).

14. P. Matousek and A.W. Parker, Raman Spectrosc. 38, 563–567 (2007).

15. T.R.M. De Beer et al., Anal. Chem. 79, 7992–8003 (2007).

16. http://www.brukeroptics.com/minispec.html.

17. I. Duarte et al., Agric. Food Chem. 50, 2475–2481 (2002).

18. C. Goudar et al., Metabolic Engin. 12, 138–149 (2010).

19. H. Metz and K. Mader, Inter. J. of Pharmaceutics 364, 170–175 (2008).

20. E. Heinzle and A. Oeggerli., Anal. Chim. Acta. 238, 101–115 (1990).

21. S. Chauvatcharins et al. Bioeng. 79, 264–269 (1995).

22. D. Smith and P. Španlm, Mass Spectrom. Rev. 24, 661–700, (2005).

23. F. Erni, J. of Chrom. 251, 141–151 (1982).

24. E.P.C. Lai, B.L.C., and S. Chen, App. Spec. 42, 381–529 (1988).


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,
Click here