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 To Develop a Bioprocess Knowledge Management Framework

Beth Junker, Gargi Maheshwari, Todd Ranheim, Nedim Altaras, Michael Stankevicz, Lori Harmon, Sandra Rios and Marc D'anjou
PDA Journal of Pharmaceutical Science and Technology March 2011, 65 (2) 140-165;
Beth Junker
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: beth.junker@merck.com
Gargi Maheshwari
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Todd Ranheim
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Nedim Altaras
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Michael Stankevicz
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Lori Harmon
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Sandra Rios
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Marc D'anjou
  • 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. Hill C.,
    2. Sinclair A.
    Process development: maximizing process data from development to manufacturing. July 2007. http://biopharminternational.findpharma.com/biopharm/Article/Process-Development-Maximizing-Process-Data-from-D/ArticleStandard/Article/detail/439424
  2. 2.↵
    1. DiMasi J. A.,
    2. Grabowski H. G.
    R&D costs and returns by therapeutic category. Drug Information Journal 2004, 38 (3), 211– 223.
    OpenUrlAbstract/FREE Full Text
  3. 3.↵
    1. Walzer M.
    Making the leap from research and development to manufacturing. Chemical Engineering 2009, 116 (12), 44– 46.
    OpenUrl
  4. 4.↵
    1. Jaluria P.,
    2. Adams D. N.
    Importance of technical operations: lessons from evolving biotherapeutics production methods. Trends in Biotechnol. 2009, 27 (11), 612– 614.
    OpenUrl
  5. 5.↵
    1. Neway J.
    How the data ecosystem affects process development and the bottom line. BioProcess Int. 2004, 2, 82– 91.
    OpenUrl
  6. 6.↵
    1. Hans J.,
    2. Bansal A.
    Biopharmaceutical information 2.0. Part 1 of 2. BioProcess Int. 2009, 7 (11), 10– 19.
    OpenUrl
  7. 7.↵
    1. Dweck R.
    Knowledge management: is the hype justified? Bio-IT World 2003, 2 (1), 28.
    OpenUrl
  8. 8.↵
    1. Gunasekaran A.,
    2. Ngai E. W. T.
    Knowledge management in 21st century manufacturing. Int. J. Production Res. 2007, 45 (11), 2391– 2418.
    OpenUrl
  9. 9.↵
    1. Lai H.,
    2. Chu T. H.
    Knowledge management: a review of industrial cases. J. Comput. Inform. Syst. 2002, 42 (5), 26– 39.
    OpenUrl
  10. 10.↵
    1. Pfeffer J.,
    2. Sutton R. I.
    Treat your organization as a prototype: the essence of evidence-based management. Design Management Rev. 2006, 17 (3), 10– 14, 80– 81.
    OpenUrl
  11. 11.↵
    International Conference on Harmonization. Q10. Pharmaceutical Quality System. Portland, Oregon, 2008.
  12. 12.↵
    1. Darroch J.
    Developing a measure of knowledge management behaviors and practices. J. Knowledge Management 2003, 7 (5), 41– 54.
    OpenUrl
  13. 13.↵
    1. Powell W. W.
    Learning from collaboration: knowledge and networks in the biotechnology and pharmaceutical industries. California Management Rev. 1998, 40 (3), 228– 240.
    OpenUrl
  14. 14.↵
    1. Somma R.
    Development knowledge can increase manufacturing capability and facilitate quality by design. J. Pharma. Innov. 2007, 2 (3–4), 87– 92.
    OpenUrl
  15. 15.↵
    1. Sapienza A. M.,
    2. Lombardino J. G.
    Recognizing, appreciating, and capturing the tacit knowledge of R&D scientists. Drug Dev. Res. 2002, 57 (2), 51– 57.
    OpenUrl
  16. 16.↵
    1. Meso P.,
    2. Smith R.
    A resource-based view of organizational knowledge management systems. J. Knowledge Management 2000, 4 (3), 224– 234.
    OpenUrl
  17. 17.↵
    1. Zucker L.,
    2. Darby M. R.,
    3. Armstrong J. S.
    Commercializing knowledge: university science, knowledge capture, and firm performance in biotechnology. Management Science 2002, 48 (1), 138– 153.
    OpenUrlCrossRefWeb of Science
  18. 18.↵
    1. Beardsley S.,
    2. Johnson B. C.,
    3. Manyika J. M.
    Competitive advantage from better interactions. The McKinsey Quarterly 2006, 2, 53– 63.
    OpenUrl
  19. 19.↵
    International Conference on Harmonization. Q8R2. Pharmaceutical development. Step 4 version. Geneva, Switzerland, 2009.
  20. 20.↵
    Process validation: general principles and practices. Guidance for Industry, United States Food and Drug Administration, 2011.
  21. 21.↵
    1. Pentland A.
    How social networks network best. Harvard Business Review 2009, 87 (2), 37.
    OpenUrlPubMed
  22. 22.↵
    1. Siddiqui A.
    Using Web 2.0 tools to increase your productivity. Chemical Engineering 2009, 116 (3), 31– 32.
    OpenUrl
  23. 23.↵
    1. Anand P.,
    2. Cox J.
    The cloud can take biopharmaceutical outsourcing to new heights. BioProcess Int. 2009, 7 (9), 20– 25.
    OpenUrl
  24. 24.↵
    1. Sansom C.
    Gathering clouds and a sequencing storm. Nature Biotechnol. 2010, 28 (1), 1, 13– 15.
    OpenUrlCrossRefPubMed
  25. 25.↵
    1. Neway J.
    Software simplifies accounting for batch genealogy. BioProcess Int. 2009, 7 (7), 32– 35.
    OpenUrl
  26. 26.↵
    1. Ilube T.
    What you need to know about the semantic web. Harvard Business Review 2009, 87 (2), 36.
    OpenUrlPubMed
  27. 27.↵
    1. Russell J.
    Novartis' answer to Harry Potter. Bio-IT World 2007, 5 (10), 24– 25.
    OpenUrl
  28. 28.↵
    1. Salamone S.
    Get serious about information mining. Bio-IT World 2006, 5 (4), 31– 32.
    OpenUrl
  29. 29.↵
    1. Studt T.
    Knowledge management is key to improving drug R&D cycles. R&D Magazine 2003, 45 (4), 18.
    OpenUrl
  30. 30.↵
    1. Pall G. S.,
    2. McGrath R. G.
    Institutional memory goes digital. Harvard Business Review 2009, 87 (2), 27.
    OpenUrl
  31. 31.↵
    1. Cutting-Decelle A. F.,
    2. Young R. I. M.,
    3. Michel J. J.,
    4. Grangel R.,
    5. Le Cardinal J.,
    6. Bourey J. P.
    ISO 15531 MANDATE: a product-process-resource based approach for managing modularity in production management. Concurrent Engineering: Research and Applications 2007, 15 (2), 217– 235.
    OpenUrlAbstract/FREE Full Text
  32. 32.↵
    1. Forgione P.
    Data management in the supply chain. BioProcess Int. 2008, 6 (10), 20– 26.
    OpenUrl
  33. 33.↵
    1. Soliman F.,
    2. Youssef M.
    The role of critical information in enterprise knowledge management. Industrial Management and Data Systems 2003, 103 (7), 484– 490.
    OpenUrl
  34. 34.↵
    1. Lee T. S.
    How process development (PD) can support product development optimization. American Pharmaceutical Review 2006, 9 (1), 110– 114.
    OpenUrl
  35. 35.↵
    1. Vestal W.
    Knowledge Mapping: The Essentials for Success. APQC Publications: Houston, TX, 2005.
  36. 36.↵
    1. DeLong D. W.
    Lost Knowledge: Confronting the Threat of an Aging Workforce; Oxford University Press: Oxford, 2004; pp 92– 94.
  37. 37.↵
    1. Hans J.,
    2. Bansal A.
    Biopharmaceutical information 2.0. Part 2 of 2. BioProcess Int. 2010, 8 (2), 10– 15.
    OpenUrl
  38. 38.↵
    1. Cross R.
    The Hidden Power of Social Networks: Understanding How Work Really Gets Done in Organization; Harvard Business School Press: Boston, MA, 2004; pp 143– 146.
  39. 39.↵
    1. McCann J. E.,
    2. Buckner M.
    Strategically integrating knowledge management initiatives. J. Knowledge Management 2004, 8 (1), 47– 63.
    OpenUrl
  40. 40.↵
    1. Von Geibler J.,
    2. Liedtke C.,
    3. Wallbaum H.,
    4. Schaller S.
    Accounting for the social dimension of sustainability: experiences from the biotechnology industry. Business Strategy and the Environment 2006, 15 (5), 334– 346.
    OpenUrlCrossRef
  41. 41.↵
    1. Palacios-Marques D.,
    2. Garrigos-Simon F. J.
    A measurement scale for knowledge management in the biotechnology and telecommunications industries. Int. J. Technol. Management 2005, 31 (3–4), 358– 374.
    OpenUrl
  42. 42.↵
    1. Muscatello J. R.
    The potential use of knowledge management for training. Business Process Management Journal 2003, 9 (3), 382– 394.
    OpenUrl
  43. 43.↵
    1. Henard D. H.,
    2. McFadyen M. A.
    Making knowledge workers more creative. Research Technology Management 2008, 51 (2), 40– 46.
    OpenUrl
  44. 44.↵
    1. Hodgson J.
    The headache of knowledge management. Nature Biotechnology 2001, 19 (Suppl.), 44– 46.
    OpenUrl
  45. 45.↵
    1. Proffitt A.
    AstraZeneca invests in data, discovery management. Bio-IT World 2008, 7 (6). http://www.bio-itworld.com/issues/2008/july-august/best-practices-astrazeneca.html
  46. 46.↵
    1. Montague G.,
    2. Martin E.
    From data to knowledge: the challenge in bioprocess development. Pharmaceutical Technology Europe 2007. At PharmTech.com. http://www.ptemag.com/pharmtecheurope/IT/From-data-to-knowledge-the-challenge-in-bioprocess/ArticleStandard/Article/detail/456156.
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 65 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 65, Issue 2
March/April 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 To Develop a Bioprocess Knowledge Management 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.
13 + 0 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Design-for-Six-Sigma To Develop a Bioprocess Knowledge Management Framework
Beth Junker, Gargi Maheshwari, Todd Ranheim, Nedim Altaras, Michael Stankevicz, Lori Harmon, Sandra Rios, Marc D'anjou
PDA Journal of Pharmaceutical Science and Technology Mar 2011, 65 (2) 140-165;

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 To Develop a Bioprocess Knowledge Management Framework
Beth Junker, Gargi Maheshwari, Todd Ranheim, Nedim Altaras, Michael Stankevicz, Lori Harmon, Sandra Rios, Marc D'anjou
PDA Journal of Pharmaceutical Science and Technology Mar 2011, 65 (2) 140-165;
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • Introduction
    • Related Internal Efforts and Recent External Technology Developments
    • KM Project Approach
    • Concept Phase Project Charter
    • Concept Phase Critical-to-Quality (CTQ) Attribute Identification
    • Concept Phase Solution Generation
    • Design/Optimization Phase Approach
    • Current State Quantification Activities To Support Design/Optimization
    • Verify Phase Identification of Gaps from the Design/Optimization Phase
    • Pilot Principles To Verify Detailed Design
    • Implementation Planning
    • Continuing Efforts toward KM Success
    • Acknowledgments
    • 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

  • Recommendations for Artificial Intelligence Application in Continued Process Verification: A Journey Toward the Challenges and Benefits of AI in the Biopharmaceutical Industry
  • A Risk Assessment and Risk-Based Approach Review of Pre-Use/Post-Sterilization Integrity Testing (PUPSIT)
  • A Review of Artificial Intelligence and Machine Learning in Product Life Cycle Management
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