Article CommentaryCommentary
The Evolution of Quality by Design (QbD) for Biologics
Anthony R. Newcombe
PDA Journal of Pharmaceutical Science and Technology July 2014, 68 (4) 320-322; DOI: https://doi.org/10.5731/pdajpst.2014.00989
Anthony R. Newcombe
Principal Consultant, PAREXEL International, Uxbridge, Middlesex, UK

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Notice of extension of deadlines to request participation in pilot program and to submit applications; and notice of increase in the number of original applications in pilot program. Federal Register 2009, 74(179).
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A-Mab: A Case Study in Bioprocess Development. CMC Biotech Working group: version 2.1, October 2009.
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A-VAX: Applying Quality by Design to Vaccines. CMC Vaccines Working Group: version 1.0 May 2012.
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- Krummen L.
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FDA Guidance for Industry: Process Validation: General Principles and Practices; U.S. FDA: Rockville, MD, January 2011.
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FDA Revision 2. Q8 (R2) Pharmaceutical Development; U.S. FDA: Rockville, MD, January 2011.
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FDA/EMEA Questions and Answers on Design Space Verification. EMEA/603905/2013, 2013.
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EMEA. ICH topic M4Q, Common Technical Document for the Registration of Pharmaceuticals for Human Use Quality; Overall Summary of Module 2 and Module 3: Quality, CPMP/ICH/2887/99, 2003.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 4
July/August 2014
The Evolution of Quality by Design (QbD) for Biologics
Anthony R. Newcombe
PDA Journal of Pharmaceutical Science and Technology Jul 2014, 68 (4) 320-322; DOI: 10.5731/pdajpst.2014.00989
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