The Challenges of Adopting Single-Use Technology - Insights on single-use systems implementation and exploitation in biopharmaceutical manufacturing and processing, based on a QbD approach. - BioPharm

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The Challenges of Adopting Single-Use Technology
Insights on single-use systems implementation and exploitation in biopharmaceutical manufacturing and processing, based on a QbD approach.


BioPharm International Supplements
Volume 25, Issue 11, pp. s4-s8

REFERENCES

1. R. Repetto, "Single Use Systems Evolution and Innovation," presented at PDA Single Use Systems Workshop (Bethesda, MD, 2011).

2. J. Martin, supp. to BioPharm Intl. 25 (11) 5–6 (2011).

3. Bio-process Systems Alliance, "FAQ, 1," http://www.bpsalliance.org/faq.html, accessed Oct. 4 2012.

4. M. Munk, "Technical Report, Section 3 Overview," presented at PDA Single Use Systems Workshop (Bethesda, MD, 2011).

5. S. Brown, "The Challenges of Adopting Single Use Technology," presented at Select Biosciences Bioprocessing & Stem Cells Conference (London, 2012).

6. Just In Time Production Strategy definition, http://www.accounting4management.com/just_in_time.htm.

7. E. Langer, BioPharm Intl. 25 (6) 24–25 (2012).

8. S. Pearson, Gen. Eng. and Biotechnology News 32 (8) (2012).

9. GE Healthcare Life Sciences, "KUbio Modular Start-to-Finish Biomanufacturing plant," http://www.gelifesciences.com, accessed Oct. 4, 2012.

10. J. Spanholtz et al., PLoS ONE, DOI:10.1371/journal.pone.0020740 (2011).

11. M. Pietrzykowski et al., "An Environmental Life Cycle Assessment Comparison of Single Use and Conventional Process Technology for the Production of Monoclonal Antibodies," presented in GEHC Disposables LCA webinar (2011).

12. Bio-process Systems Alliance, "Technical Guide on Extractables and Leachables," http://www.bpsalliance.org/guides.html, accessed 4 Oct. 2012.

13. B. Littlefield, "Determination of Extractables/Leachables From Integrated Single-Use Systems," presented at PDA Conference on Biopharmaceutical Development and Manufacturing (Munich, 2009).

14. V. Gupta, "An Approach to Assessing the Risk of Extractables and Leachables from Single-Use Systems," presented at ISPE Conference on Disposables and Containment (Strasbourg, 2009).

15. I. Markovic, "Considerations for Extractables and Leachables in Single Use Systems: A Risk-Based Perspective," presented at PDA Single Use Systems Workshop (Bethesda, MD, 2011).

16. P.L. Pluta, "QbD and Process Validation –Complementary Lifecycle Approaches, in Quality By Design," Chapter 6 of Putting Theory Into Practice, S. Schmitt, Ed. (PDA/DHI, 2011).

17. H.N. Winkle, "Implementing Quality by Design" (refer to the table on page 10), presented at PDA/FDA Joint Regulatory Conference (Washington, DC, 2007).

18. FDA, Guidance on Process Validation: General Principles and Practices (Rockville, MD, Jan. 2011).

19. ASTM, E2500–07 Standard Guide for Specification, Design, and Verification of Pharmaceutical Manufacturing Systems and Equipment (2007).

20. ASTM, E2537-08 Standard Guide for Application of Continuous Quality Verification to Pharmaceutical and Biopharmaceutical Manufacturing (2008).

21. ICH, Q8 Pharmaceutical Development (2009).

22. ICH, Q9 Quality Risk Management (2005).

23. ICH, Q10 Pharmaceutical Quality System (2008).

24. Stress Management from Mind Tools website, "Stakeholder Management," http://www.mindtools.com/stress/pp/StakeholderManagement.htm, accessed Oct. 4 2012.

25. R. Repetto, "PDA Task Force for Single Use Systems," presented at PDA Single Use Systems Workshop (Bethesda, MD, 2011).

26. Low, D, PDA Single Use Systems Workshop (Bethesda, MD, 2011).

27. A.S. Rathore et al., BioPharm Intl. 23 (11) 34–40 (2010).

28. EU-GMP Annex 2: Manufacture of Biological Active Substances and Medicinal Products for Human Use, EudraLex Volume 4, The Rules Governing Medicinal Products in the EU (Application from Jan. 31, 2013), http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm.

29. S. Brown, "Technical Report Section 7 Implementation of Single-Use Systems," presented at Single Use Systems Workshop (Bethesda, MD, 2011).


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