PharmTech Drug Digest 11.20
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News|Articles|February 1, 2010

Quality by Design for biotechnology products: challenges and solutions — References

References for the article published in the February issue of Pharmaceutical Technology Europe.

References for the article published in the print issue of Pharmaceutical Technology Europe.

  1. FDA PAT Guidance for Industry — A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance, September 2004. www.fda.gov
  2. FDA Guidance for Industry: Q8 Pharmaceutical Development May 2006. Q8 Annex Pharmaceutical Development, Step 3, November, 2007.
  3. FDA Guidance for Industry: Q9 Quality Risk Management, June 2006.
  4. FDA Guidance for Industry: Q10 Quality Systems Approach to Pharmaceutical CGMP Regulations, September, 2006.
  5. A.S. Rathore and H. Winkle, Nature Biotechnology, 27, 26–34 (2009).
  6. S. Kozlowski and P. Swann, "Considerations for biotechnology product Quality by Design," in A.S. Rathore and R. Mhatre, Eds, Quality by Design for Biopharmaceuticals: Perspectives and Case Studies (Wiley Interscience, NJ, USA 2009) pp 9–30.
  7. A.S. Rathore et al., BioPharm Intl., 21(12), 37–41 (2008).
  8. T. Arora et al., BioPharm Intl., 22(11), (2009).
  9. A.S. Rathore, R. Branning and D. Cecchini, BioPharm Intl., 20(4), 36–40 (2007).
  10. A.S. Rathore et al., BioPharm Intl., 22(1), (2009).
  11. J. Harms et al., Biotech. Prog., 24(3), 655–662 (2008).
  12. P. van Hoek et al., "Case Study on Definition of Design Space for a Microbial Fermentation Step," in A.S. Rathore and R. Mhatre, Eds, Quality by Design for Biopharmaceuticals: Perspectives and Case Studies, (Wiley Interscience, NJ, USA, 2009) pp 85–109.
  13. D.J. Cecchini, "Applications of design space for biopharmaceutical purification processes," in A.S. Rathore and R. Mhatre, Eds, Quality by Design for Biopharmaceuticals: Perspectives and Case Studies (Wiley Interscience, NJ, USA, 2009) pp. 127–141.
  14. P.K. Watler and J. Rozembersky, "Application of QbD principles to tangential flow filtration operations," in A.S. Rathore and R. Mhatre, Eds, Quality by Design for Biopharmaceuticals: Perspectives and Case Studies (Wiley Interscience, NJ, USA, 2009) pp 111–125.
  15. K. Ng and N. Rajagopalan, "Application of Quality by Design and risk assessment principles for the development of formulation design space," in A.S. Rathore and R. Mhatre, Eds, Quality by Design for Biopharmaceuticals: Perspectives and Case Studies (Wiley Interscience, NJ, USA, 2009) pp 161–174.
  16. A.S. Rathore, Trends in Biotechnology, 27, 546–553 (2009).
  17. A-Mab, A Case Study in Bioprocess Development (2009). www.ispe.org
  18. A.S. Rathore, Trends in Biotechnology, 27(12), 698–705 (2009).
  19. S. Kozlowski, BIO/FDA Liaison Meeting on QbD (September 2008).
  20. H. Schellekens, Nephrol. Dial. Transplant. 2(Suppl. 1), i27–i36 (2009).
  21. A.O. Kirdar et al., Biotech. Prog., 23, 61–67 (2007).
  22. A.A. Shukla et al., Journal of Chromatography B, 848(1), 28–39 (2008).
  23. B.S. Kendrick et al., BioPharm Intl., 22(8), 32–44 (2009).
  24. D.M. Boyle et al., Biotechnol. Appl. Biochem., 54(2), 85–92 (2009).
  25. A.O. Kirdar, K.D. Green and A.S. Rathore, Biotech. Prog., 24(3), 720–726 (2008).
  26. M.A. Schenerman et al., "Using a Risk Assessment Process to Determine Criticality of Product Quality Attributes," in A.S. Rathore and R. Mhatre, Eds, Quality by Design for Biopharmaceuticals. Wiley Interscience, NY, USA, 2009) pp 53–84.
  27. FDA, Notice of pilot programme for submission of quality information for biotechnology products in the Office of Biotechnology Products, Docket number FDA-2008-N-03551.

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