Skip to main content

Main menu

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore

User menu

  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart

Search

  • Advanced search
PDA Journal of Pharmaceutical Science and Technology
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore
  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart
PDA Journal of Pharmaceutical Science and Technology

Advanced Search

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • Follow pda on Twitter
  • Visit PDA on LinkedIn
  • Visit pda on Facebook
Review ArticleReview

Design-for-Six-Sigma for Development of a Bioprocess Quality-by-Design Framework

Beth Junker, Mike Kosinski, David Geer, Rajiv Mahajan, Michel Chartrain, Brian Meyer, Peter Dephillips, Yang Wang, Randy Henrickson, Katie Ezis and Mark Waskiewicz
PDA Journal of Pharmaceutical Science and Technology May 2011, 65 (3) 254-286; DOI: https://doi.org/10.5731/pdajpst.2011.00739
Beth Junker
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Mike Kosinski
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
David Geer
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Rajiv Mahajan
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Michel Chartrain
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Brian Meyer
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Peter Dephillips
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Yang Wang
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Randy Henrickson
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Katie Ezis
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Mark Waskiewicz
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
Loading

References

  1. 1.↵
    1. Kozlowski S.
    , CDER. Biotechnology Products and Agenda Initiatives. Well Characterized Biological Products. Bethesda, MD. January, 2009.
  2. 2.↵
    1. Wechsler J.
    Regulatory beat: Quality standards to reshape manufacturing. Biopharm. 2004b, 20 (2).
  3. 3.↵
    1. Rathore A. S.,
    2. Winkle H.
    Quality by design for biopharmaceuticals. Nature Biotechnology 2009, 27 (1), 26–34.
    OpenUrlCrossRefPubMedWeb of Science
  4. 4.↵
    1. Langille S.,
    2. Ensor L.,
    3. Hussong D.
    Quality by design for pharmaceutical microbiology. Am. Pharm. Rev. 2009, 12 (6), 80–83.
    OpenUrl
  5. 5.↵
    United States FDA. Pharmaceutical cGMPs for the 21st century—a risk-based approach. September 2004. http://www.fda.gov/cder/gmp/gmp2004/gmpfinalreport2004.htm
  6. 6.↵
    ICH. Q8R2 Pharmaceutical development, Step 4 version. August 2009.
  7. 7.↵
    1. Woodcock J.
    The concept of pharmaceutical quality. Am. Pharm. Rev. 2004, Nov/Dec.
  8. 8.↵
    1. Neway J.
    How to make the business case for quality by design. Biopharm Int. 2008, 21 (12), 42–47.
    OpenUrl
  9. 9.↵
    1. Winkle H. N.
    Implemented Quality by Design. PDA/FDA Joint Regulatory Conference. Evolution of the Global Regulatory Environment: A Practical Approach to Change. Washington, DC. September 2007.
  10. 10.↵
    1. Wechsler J.
    FDA promotes QbD for biotech therapies. 2008. http://biopharminternational.findpharma.com/biopharm/Quality/FDA-Promotes-QbD-for-Biotech-Therapies/ArticleStandard/Article/detail/557244
  11. 11.↵
    1. Neway J.
    Quality by design is essential in the new US regulatory environment Next Generation Pharmaceutical 2009, 10 (emagazine) http://www.pharma.com/article/Quality-by-Design-is-Essential-in-the-New-US-Regulatory-Environment/
  12. 12.↵
    1. Meyers C. A.,
    2. Weigl D.
    QbD and GMPs: How the convergence of science and compliance will change the way we work. Bioprocess Int. 2009, 7 (11), 22–25.
    OpenUrl
  13. 13.↵
    1. Lepore J.,
    2. Spavins J.
    PQLI design space. J. Pharm. Innov. 2008, 3, 79–87.
    OpenUrl
  14. 14.↵
    1. Arora T.,
    2. Greene R.,
    3. Mercer J.,
    4. Tsang P.,
    5. Casais M.,
    6. Feldman S.,
    7. Look J.,
    8. Lubiniecki T.,
    9. Mezzatesta J.,
    10. Pluschkell S.,
    11. Rosolowsky M.,
    12. Rathore A.,
    13. Schenerman M.,
    14. Schofield T.,
    15. Sheridan S.,
    16. Smock P.,
    17. Anliker S.,
    18. Atkins L.,
    19. McGarvey B.,
    20. Meiklejohn B.,
    21. Precup J.,
    22. Towns J.
    QbD Working Group of PhRMA Biologics and Biotechnology Leadership Committee ( Arora T., Greene R., Mercer J., Tsang P., Casais M., Feldman S., Look J., Lubiniecki T., Mezzatesta J., Pluschkell S., Rosolowsky M., Rathore A., Schenerman M., Schofield T., Sheridan S., Smock P., Anliker S., Atkins L., McGarvey B., Meiklejohn B., Precup J., Towns J.). Quality by design for biotechnology products, part 3. BioPharm Int. 2010, 23 (1), 36–45.
    OpenUrl
  15. 15.↵
    1. Neway J.
    Practicalities for QbD. Pharmaceutical Processing 2009, 24 (2), 8–16.
    OpenUrl
  16. 16.↵
    1. Dwyer T.,
    2. Keresty G.,
    3. Sherry C.
    The cost of non-conformance: the linkage between quality performance and business results. Pharmaceutical Engineering 2000, 20 (5), 8–18.
    OpenUrl
  17. 17.↵
    1. Ishire S. J.
    1. Myers M.,
    2. Keating C.,
    3. Bannon J.,
    4. Neblock D. S.,
    5. Wojciechowski P. W.
    Chapter 6. Addressing Changes Associated with Technology Transfer: A Case Study. In Current Trends in Monoclonal Antibody Development and Manufacturing; Ishire S. J., Ed.; Springer/American Association of Pharmaceutical Scientists: New York, 2010; pp 75–85.
  18. 18.↵
    1. Shukla A,
    2. Etzel M,
    3. Gadam S
    1. Wojciechowski P. W.,
    2. Smit H. I.,
    3. Myers M. M.,
    4. Voronko P. J.,
    5. Laverty T.,
    6. Ramelmeier R. A.,
    7. Siegel R. C.
    Chapter 18. Making changes to a biopharmaceutical manufacturing process during development and commercial manufacturing: the REMICADE story. In Process scale Bioseparations for the Biopharmaceutical Industry; Shukla A, Etzel M, Gadam S, Eds.; CRC Press: Boca Raton, FL, 2007; Vol. 11, pp 507–522.
    OpenUrl
  19. 19.↵
    1. Torbeck L.,
    2. Branning R.
    QbD: convincing the skeptics. Biopharm Int. 2009, 22 (5), 52–58.
    OpenUrl
  20. 20.↵
    1. Mendivil S.,
    2. Burns A.
    Quality by design: Current regulatory status and future challenges. BioProcess Int. 2009, 7 (Suppl. 1), 84–87.
    OpenUrl
  21. 21.↵
    1. DiMasi J. A.,
    2. Feldman L.,
    3. Seckler A.,
    4. Wilson A.
    Trends in risks associated with new drug development: success rates for investigational drugs. Clinical Pharmacology & Therapeutics 2010, 87 (3), 272–277.
    OpenUrl
  22. 22.↵
    1. Rathore A. S.,
    2. Saleki-Gerhardt A.,
    3. Montgomery S. H.,
    4. Tyler S. M.
    Quality by design: industrial case studies on defining and implementing design space for pharmaceutical processes, Part 1. BioPharm Int. 2008, 21 (12), 37–41, 47.
    OpenUrl
  23. 23.↵
    1. Kenett R. S.,
    2. Kenett D. A.
    Quality by design applications in biosimilar pharmaceutical products. Accred. Qual. Assur. 2008, 13, 681–690.
    OpenUrl
  24. 24.↵
    1. Bohlin M.,
    2. Jones H.,
    3. Black S.
    New developments in scale-up and QbD to ensure control over product quality. Am. Pharm. Rev. 2009, 12, 52–57.
    OpenUrl
  25. 25.↵
    1. Tulsi B.
    Quality-by-design gets mixed reception from industry. Life Science Leader 2009, 1 (6), 32–33.
    OpenUrl
  26. 26.↵
    1. Julien C.,
    2. Whitford W.
    The biopharmaceutical industry's new operating paradigm. BioPharm. 2008, 6 (Suppl. 1), 6–14.
    OpenUrl
  27. 27.↵
    1. Wechsler J.
    Industry, regulators move to adopt quality standards. Pharmaceutical Technology 2007, 31 (2), 30–40.
    OpenUrl
  28. 28.↵
    1. Shacter E.
    FDA perspectives on the analytical characterization of follow-on protein products. American Chemical Society, San Francisco, March 24, 2010.
  29. 29.↵
    1. Banerjee A.
    Designing in quality: Approaches to defining the design space for a monoclonal antibody. Biopharm Intl. 2010, 23 (5), 26–40.
    OpenUrl
  30. 30.↵
    1. Shire S. J.
    1. Heath C.
    Chapter 5. Advancing Our Cell Culture Platform: Incorporating Lessons Learned and New Technologies. In Current trends in monoclonal antibody development and manufacturing; Shire S. J., Ed.; Springer/American Association of Pharmaceutical Scientists: New York, 2010; pp 63–72.
  31. 31.↵
    1. Arora T.,
    2. Greene R.,
    3. Mercer J.,
    4. Tsang P.,
    5. Casais M.,
    6. Feldman S.,
    7. Look J.,
    8. Lubiniecki T.,
    9. Mezzatesta J.,
    10. Pluschkell S.,
    11. Rosolowsky M.,
    12. Rathore A.,
    13. Schenerman M.,
    14. Schofield T.,
    15. Sheridan S.,
    16. Smock P.,
    17. Anliker S.,
    18. Atkins L.,
    19. McGarvey B.,
    20. Meiklejohn B.,
    21. Precup J.,
    22. Towns J.
    QbD working group of PhRMA biologics and biotechnology leadership committee ( Arora T., Greene R., Mercer J., Tsang P., Casais M., Feldman S., Look J., Lubiniecki T., Mezzatesta J., Pluschkell S., Rosolowsky M., Rathore A., Schenerman M., Schofield T., Sheridan S., Smock P., Anliker S., Atkins L., McGarvey B., Meiklejohn B., Precup J., Towns J.). Quality by design for biotechnology products, Part 1. BioPharm Int. 2009, 22 (11), 26–36.
    OpenUrl
  32. 32.↵
    1. Adams M.
    Design for six sigma: A potent supplement to QbD. Pharmaceutical Manufacturing 2000, 9 (2), 36–39.
    OpenUrl
  33. 33.↵
    1. Heilman C. J.
    Coming to a biotech near you: quality by design. Part 1: its applicability in Biopharmaceuticals. BioPharm International 2008, 21 (5), 30–32.
    OpenUrl
  34. 34.↵
    ICH. Q9 Quality risk management, Step 4 version, January 2006.
  35. 35.↵
    ICH. Q10 Pharmaceutical quality systems, April 2009.
  36. 36.↵
    ICH. Q11 Development and manufacturing of drug substances (chemical entities and biotechnological/biological entities, Draft 3 version, January 2010.
  37. 37.↵
    United States FDA. Process validation: General principles and practices, Guidance for Industry, January 2011.
  38. 38.↵
    Parenteral Drug Association PDA Technical Report 42. Process validation of protein manufacturing. 59 (S-4), 1–28, (2005 Sep). Bethesda, MD: PDA.
  39. 39.↵
    1. Avellanet J.
    FDA Forecast: Nine recommendations to weather the new year. Pharmaceutical Processing 2009, 24 (1), 8–11.
    OpenUrl
  40. 40.↵
    1. Shanley A.
    From the editor: Validating process validation. 2008. http://pharmamanufacturing.com/articles/2008/171.html
  41. 41.↵
    1. Garcia T.,
    2. Cook G.; ,
    3. Nosal R.
    PQLI key topics—Criticality, design space, and control strategy. J Pharm. Innov. 2008, 3, 60–68.
    OpenUrl
  42. 42.↵
    1. Weinberg S.
    Taming the QbD elephant: A stochastic model. 2010. http://www.pharmaqbd.com/node/220
  43. 43.↵
    1. Rathore A. S.,
    2. Saleki-Gerhardt A.,
    3. Montgomery S. H.,
    4. Tyler S. M.
    Quality by design: industrial case studies on defining and implementing design space for pharmaceutical processes, Part 2. BioPharm Int. 2009, 22 (1), 36–44.
    OpenUrl
  44. 44.↵
    United States FDA. PAT—A framework for innovative pharmaceutical manufacturing and quality assurance. Guidance for Industry, 2004.
  45. 45.↵
    1. O'Kennedy R.
    PAT for the product lifecycle of a biopharmaceutical product. Am. Pharm. Rev. 2008, 11 (1), 104–108.
    OpenUrl
  46. 46.↵
    1. Berridge J. C.
    PQLI—What is it? Pharm. Eng. 2009, 29 (3), 36–39.
    OpenUrl
  47. 47.↵
    1. Hans J.,
    2. Bansal A.
    Biopharmaceutical information infrastructure, 2.0 (Part 1 of 2). Bioprocess Int. 2009, 7 (11), 10–19.
    OpenUrl
  48. 48.↵
    1. Meyers C. A.,
    2. Weigl D.
    Quality by design and compliance readiness. BioPharm Int. 2010, 23 (1), 22–25.
    OpenUrl
  49. 49.↵
    1. Coakley J.,
    2. Hogan N.,
    3. McGuire L.,
    4. Griffin B.,
    5. Casey C.,
    6. Campbell C.,
    7. Crean A.
    A methodology for knowledge management in biopharmaceutical production. Pharm. Eng. 2010, 30 (3), 30–40.
    OpenUrl
  50. 50.↵
    1. Arora T.,
    2. Greene R.,
    3. Mercer J.,
    4. Tsang P.,
    5. Casais M.,
    6. Feldman S.,
    7. Look J.,
    8. Lubiniecki T.,
    9. Mezzatesta J.,
    10. Pluschkell S.,
    11. Rosolowsky M.,
    12. Rathore A.,
    13. Schenerman M.,
    14. Schofield T.,
    15. Sheridan S.,
    16. Smock P.,
    17. Anliker S.,
    18. Atkins L.,
    19. McGarvey B.,
    20. Meiklejohn B.,
    21. Precup J.,
    22. Towns J.
    QbD Working Group of PhRMA Biologics and Biotechnology Leadership Committee ( Arora T., Greene R., Mercer J., Tsang P., Casais M., Feldman S., Look J., Lubiniecki T., Mezzatesta J., Pluschkell S., Rosolowsky M., Rathore A., Schenerman M., Schofield T., Sheridan S., Smock P., Anliker S., Atkins L., McGarvey B., Meiklejohn B., Precup J., Towns J.). Quality by design for biotechnology products, part 2. BioPharm Int. 2009, 22 (12), 42–58.
    OpenUrl
  51. 51.↵
    1. Venkateshwaran T. G.,
    2. Simmons S. P.,
    3. Jagota N.,
    4. Esherick D. G.,
    5. Mann P. F.
    Global regulatory submissions for QbD. Pharmaceutical Technology 2009, 33 (10), 96–102.
    OpenUrl
  52. 52.↵
    1. Whitford W.,
    2. Julien C.
    Towards better biopharmaceutical process design and control. BioPharm. 2008, 6 (Suppl. 1), 4.
    OpenUrl
  53. 53.↵
    1. Krause S. O.
    QbD for analytical methods. BioPharm Int. 2009, 22 (2), 58.
    OpenUrl
  54. 54.↵
    1. Cox B.
    Attention turns to business case for quality by design. The Gold Sheet, CDC Reports 2009, 43 (1), 1–9.
    OpenUrl
  55. 55.↵
    1. Sinclair A.,
    2. Monge M.
    Delivering affordable biologics from gene to vial. Bioprocess Int. 2010, 8 (3), 16–19.
    OpenUrl
  56. 56.↵
    1. Benevento M.,
    2. Bornsztejn V.
    Early validation, the difference between success and failure. Drug Discovery World 2009, 10 (3), 83–86.
    OpenUrl
  57. 57.↵
    1. Mire-Sluis A.,
    2. Schenerman M.,
    3. Mhatre R.,
    4. Advant S.,
    5. Dougherty J.,
    6. Kozlowski S.,
    7. Nashabeh W.,
    8. McLeod L.
    Quality by design: The next phase. BioProcess Int. 2009, 7 (1), 34–43.
    OpenUrl
  58. 58.↵
    1. Bush L.
    Quality risk management demystified at CMC strategy forum. Biopharm Int. 2009, 22 (9), 20–26.
    OpenUrl
  59. 59.↵
    1. Yu L. X.,
    2. Lionberger R.,
    3. Olson M C.,
    4. Johnston G.,
    5. Buehler G.,
    6. Winkle H.
    Quality by design for generic drugs. Pharm. Technol. 2009, 33 (10), 122–127.
    OpenUrl
  60. 60.↵
    1. Rathore A. S.
    Roadmap for implementation of quality by design (QbD) for biotechnology products. Trends Biotechnol. 2009 27 (9), 546–553.
    OpenUrlCrossRefPubMed
  61. 61.↵
    1. Ende D.,
    2. Bronk K. S.,
    3. Mustakis J.,
    4. O'Connor G.,
    5. Santa Maria C. L.,
    6. Nosal R.,
    7. Watson T. J. N.
    API quality by design example from torcetrapid manufacturing process. J. Pharm. Innov. 2007, 2 (3–4), 71–86.
    OpenUrl
  62. 62.↵
    1. Butler M. D.,
    2. Kluck B.,
    3. Bently T.
    DNA spike studies for demonstrating improved clearance on chromatographic media. J. Chromatogr., A 2009, 1216, 6938–6945.
    OpenUrlPubMed
  63. 63.↵
    1. Scholfield T.,
    2. Apostol I.,
    3. Koeller G.,
    4. Poers S.,
    5. Stawicki M.,
    6. Wolfe R. A.
    A rational approach for setting and maintaining specifications for biological and biotechnology-derived products—Part 3. Biopharm. 2008, 21 (8).
  64. 64.↵
    1. Hudson P. S.,
    2. Baker D. D.
    The post approval management plan/A tool to apply science- and risk-based approaches. Pharm. Technol. 2009, 33 (1), 82–86.
    OpenUrl
  65. 65.↵
    1. Montague G.,
    2. Martin E.
    The challenge in bioprocess development: from data to knowledge. Pharmaceutical Technology Europe 2007, 19 (9), 71–75.
    OpenUrl
  66. 66.↵
    1. Nosal R.,
    2. Schultz T.
    PQLI definition of criticality. J. Pharm. Innov. 2008, 3 (2), 69–78.
    OpenUrl
  67. 67.↵
    CMC biotech working group, A-Mab: A case study in bioprocess development. Version 2.1; Oct 30, 2009; http://www.ispe.org/pqli
  68. 68.↵
    1. Bush L.
    Determining critical quality attributes form the foundation for QbD implementation. BioPharm Int. 2008, 21 (9), 12–14.
    OpenUrl
  69. 69.↵
    1. Taticek R.
    Implementation of QbD for large molecules: lessons learned (so far). Biomanufacturing Summit, San Diego CA, (January 28, 2009).
  70. 70.↵
    1. Viornery L.,
    2. Legoff P.
    Implementing quality risk management. Pharm. Technol. 2009, 33 (12), 50–53.
    OpenUrl
  71. 71.↵
    1. MacGregor J. F.,
    2. Bruwer M. J.
    A framework for the development of design and control spaces. J. Pharm. Innov. 2008, 3 (1), 15–22.
    OpenUrl
  72. 72.↵
    1. Paul S. M.
    How to improve R&D productivity: the pharmaceutical industry's grand challenge. Nature Reviews Drug Discovery 2010, 9, 203–214.
    OpenUrlCrossRefPubMedWeb of Science
  73. 73.↵
    1. Moreton C.
    Functionality and performance of excipients in a quality-by-design world, Part 2: Excipient variability, QbD and robust formulations. Am. Pharm. Rev. 2009, 12 (2), 40–45.
    OpenUrl
  74. 74.↵
    1. Tsai A.
    Connecting process characterization with process validation. IBC Life Sciences, Carlsbad, CA, March 2009.
  75. 75.↵
    1. Rathore A. S.
    Setting specifications for a biotech therapeutic product in the quality by design paradigm. BioPharm Int. 2010, 23 (1), 46–53.
    OpenUrl
  76. 76.↵
    1. Peterson J. J.
    What your ICH Q8 design space needs: A multivariate predictive distribution. Pharmaceutical Manufacturing 2009, 8 (10), 23–28.
    OpenUrl
  77. 77.↵
    1. Julien C.,
    2. Whitford W.
    A new era for bioprocess design and control, Part 1. BioPharm 2008, 6 (Suppl. 1), 16–23.
    OpenUrl
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 65 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 65, Issue 3
May/June 2011
  • Table of Contents
  • Index by Author
Print
Download PDF
Article Alerts
Sign In to Email Alerts with your Email Address
Email Article

Thank you for your interest in spreading the word on PDA Journal of Pharmaceutical Science and Technology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Design-for-Six-Sigma for Development of a Bioprocess Quality-by-Design Framework
(Your Name) has sent you a message from PDA Journal of Pharmaceutical Science and Technology
(Your Name) thought you would like to see the PDA Journal of Pharmaceutical Science and Technology web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
1 + 4 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Design-for-Six-Sigma for Development of a Bioprocess Quality-by-Design Framework
Beth Junker, Mike Kosinski, David Geer, Rajiv Mahajan, Michel Chartrain, Brian Meyer, Peter Dephillips, Yang Wang, Randy Henrickson, Katie Ezis, Mark Waskiewicz
PDA Journal of Pharmaceutical Science and Technology May 2011, 65 (3) 254-286; DOI: 10.5731/pdajpst.2011.00739

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Design-for-Six-Sigma for Development of a Bioprocess Quality-by-Design Framework
Beth Junker, Mike Kosinski, David Geer, Rajiv Mahajan, Michel Chartrain, Brian Meyer, Peter Dephillips, Yang Wang, Randy Henrickson, Katie Ezis, Mark Waskiewicz
PDA Journal of Pharmaceutical Science and Technology May 2011, 65 (3) 254-286; DOI: 10.5731/pdajpst.2011.00739
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • Introduction
    • Related Initiatives
    • QbD Project Approach
    • Concept Phase Project Charter
    • Concept Phase Current State Assembly
    • Concept Phase House-of-Quality (HOQ) Development & Critical-to-Quality (CTQ) Summary
    • Design/Optimize Phase Approach
    • Design/Optimize Phase Outcome
    • Verify Phase Identification of Gaps from the Design/Optimize Phase
    • Internal Pilots and Mentoring Approach to Verify Detailed Design
    • Implementation Planning
    • Implementation Control Mechanisms
    • Summarized Efforts Towards QbD Success
    • Acknowledgements
    • Footnotes
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • No citing articles found.
  • Google Scholar

More in this TOC Section

  • The Role of Microbiologists in Drug Product Development
  • A Risk Assessment and Risk-Based Approach Review of Pre-Use/Post-Sterilization Integrity Testing (PUPSIT)
  • Recommendations for Artificial Intelligence Application in Continued Process Verification: A Journey Toward the Challenges and Benefits of AI in the Biopharmaceutical Industry
Show more Review

Similar Articles

Readers

  • About
  • Table of Content Alerts/Other Alerts
  • Subscriptions
  • Terms of Use
  • Contact Editors

Author/Reviewer Information

  • Author Resources
  • Submit Manuscript
  • Reviewers
  • Contact Editors

Parenteral Drug Association, Inc.

  • About
  • Advertising/Sponsorships
  • Events
  • PDA Bookstore
  • Press Releases

© 2025 PDA Journal of Pharmaceutical Science and Technology Print ISSN: 1079-7440  Digital ISSN: 1948-2124

Powered by HighWire