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

Article

Pharmaceutical Technology Europe

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.

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  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.
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  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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