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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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References

  1. 1.↵
    Submission of quality information for biotechnology products in the Office of Biotechnology Products; notice of pilot program. Federal Register 2008, 73(128).
  2. 2.↵
    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).
  3. 3.↵
    A-Mab: A Case Study in Bioprocess Development. CMC Biotech Working group: version 2.1, October 2009.
  4. 4.↵
    A-VAX: Applying Quality by Design to Vaccines. CMC Vaccines Working Group: version 1.0 May 2012.
  5. 5.↵
    1. Krummen L.
    Quality by Design Implementation for Biologics: Lessons Learned from the FDA Pilot Program. International Conference on Accelerating Biopharmaceutical Development and Quality by Design in Biologics, AIChE proceedings, February 27, 2013.
  6. 6.↵
    1. Martin-Moe S.,
    2. Lim F. J.,
    3. Wong R. L.,
    4. Sreedhara A.,
    5. Sundaram J.,
    6. Sane S. U.
    A new roadmap for biopharmaceutical drug product development: integrating development, validation, and quality by design. J. Pharm. Sci. 2011, 100(8), 3031–3043.
    OpenUrlPubMed
  7. 7.↵
    FDA Guidance for Industry: Process Validation: General Principles and Practices; U.S. FDA: Rockville, MD, January 2011.
  8. 8.↵
    FDA Revision 2. Q8 (R2) Pharmaceutical Development; U.S. FDA: Rockville, MD, January 2011.
  9. 9.↵
    FDA/EMEA Questions and Answers on Design Space Verification. EMEA/603905/2013, 2013.
  10. 10.↵
    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.
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PDA Journal of Pharmaceutical Science and Technology: 68 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 4
July/August 2014
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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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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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