Research ArticleTechnology/Application

Multiproduct Resin Reuse for Clinical and Commercial Manufacturing—Methodology and Acceptance Criteria

Rizwan Sharnez, Steve Doares, Shane Manning, Krunal Mehta, Ekta Mahajan, Angela To, William Daniels, Judy Glynn, Sagar Dhamane, Xiaona Wen, Yunjuan Wang, Pankaj Gour, Constanze Guenther, Derek Foley, Ronan Hayes, Adam Mott, Sunil Prabhu, Dawn Tavalsky, Michael Hendershot, David Haas, Ashley Hesslein, Norbert Schuelke and Hendri Tjandra
PDA Journal of Pharmaceutical Science and Technology November 2018, 72 (6) 584-598; DOI: https://doi.org/10.5731/pdajpst.2016.007245

Article Information

vol. 72 no. 6 584-598
DOI 
https://doi.org/10.5731/pdajpst.2016.007245
PubMed 
30030349
Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online December 4, 2018.

Article Versions

Copyright & Usage 
© PDA, Inc. 2018

Author Information

  1. Rizwan Sharnez1,*,
  2. Steve Doares2,
  3. Shane Manning3,
  4. Krunal Mehta1,
  5. Ekta Mahajan4,
  6. Angela To5,
  7. William Daniels6,
  8. Judy Glynn6,
  9. Sagar Dhamane1,
  10. Xiaona Wen1,
  11. Yunjuan Wang7,
  12. Pankaj Gour8,
  13. Constanze Guenther8,
  14. Derek Foley9,
  15. Ronan Hayes9,
  16. Adam Mott10,
  17. Sunil Prabhu11,
  18. Dawn Tavalsky12,
  19. Michael Hendershot13,
  20. David Haas12,
  21. Ashley Hesslein14,
  22. Norbert Schuelke15 and
  23. Hendri Tjandra14
  1. 1Amgen;
  2. 2Biogen;
  3. 3GlaxoSmithKline;
  4. 4Roche-Genentech;
  5. 5Hyde Engineering and Consulting;
  6. 6Pfizer;
  7. 7AstraZeneca;
  8. 8Novartis;
  9. 9Johnson & Johnson-Janssen;
  10. 10Lonza;
  11. 11Merck & Co., Inc.;
  12. 12Sanofi;
  13. 13Eli Lilly & Co.;
  14. 14Bayer;
  15. 15Takeda Pharmaceuticals
  1. ↵* Corresponding Author: Cleaning Validation Solutions, 3506 Vale View Lane, Mead, CO 80542, USA; e-mail: rsharnez{at}CleaningValidationSolutions.com
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Multiproduct Resin Reuse for Clinical and Commercial Manufacturing—Methodology and Acceptance Criteria
Rizwan Sharnez, Steve Doares, Shane Manning, Krunal Mehta, Ekta Mahajan, Angela To, William Daniels, Judy Glynn, Sagar Dhamane, Xiaona Wen, Yunjuan Wang, Pankaj Gour, Constanze Guenther, Derek Foley, Ronan Hayes, Adam Mott, Sunil Prabhu, Dawn Tavalsky, Michael Hendershot, David Haas, Ashley Hesslein, Norbert Schuelke, Hendri Tjandra
PDA Journal of Pharmaceutical Science and Technology Nov 2018, 72 (6) 584-598; DOI: 10.5731/pdajpst.2016.007245
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