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
Rizwan Sharnez
1Amgen;
Steve Doares
2Biogen;
Shane Manning
3GlaxoSmithKline;
Krunal Mehta
1Amgen;
Ekta Mahajan
4Roche-Genentech;
Angela To
5Hyde Engineering and Consulting;
William Daniels
6Pfizer;
Judy Glynn
6Pfizer;
Sagar Dhamane
1Amgen;
Xiaona Wen
1Amgen;
Yunjuan Wang
7AstraZeneca;
Pankaj Gour
8Novartis;
Constanze Guenther
8Novartis;
Derek Foley
9Johnson & Johnson-Janssen;
Ronan Hayes
9Johnson & Johnson-Janssen;
Adam Mott
10Lonza;
Sunil Prabhu
11Merck & Co., Inc.;
Dawn Tavalsky
12Sanofi;
Michael Hendershot
13Eli Lilly & Co.;
David Haas
12Sanofi;
Ashley Hesslein
14Bayer;
Norbert Schuelke
15Takeda Pharmaceuticals
Hendri Tjandra
14Bayer;

Reference
- 1.↵
- Sharnez R.,
- Lathia J.,
- Kahlenberg D.,
- Prabhu S.,
- Dekleva M.
- 2.↵
- Canhoto A.
- 3.↵
- Sharnez R.,
- To A.,
- Tholudur A.
- 4.↵
- Sharnez R.,
- To A.,
- Annapragada R.
- 5.↵
- Pluta P.
- 6.↵
- Verghse G.,
- Kaiser N.
- 7.↵
- Verghese G.,
- Thomas J.
- 8.↵
- Sharnez R.,
- Klewer L.
- 9.↵
- Sharnez R.,
- VanTrieste M.
- 10.↵
- Sharnez R.
- 11.↵
- Sharnez R.
- 12.↵
- 13.↵
- Mahajan E.,
- Werber J.,
- Kothary K.,
- Larson T.
- 14.↵
- Sharnez R.,
- To A.
- 15.↵
- Sharnez R.,
- Bussiere J.,
- Mytych D.,
- Spencer A.,
- To A.,
- Tholudur A.
- 16.↵
- Sharnez R.,
- et al
- 17.↵
- Kendrick K.,
- Canhoto A.,
- Kreuze M.
- 18.↵International Society for Pharmaceutical Engineers: Tampa, Florida. Risk-Based Manufacture of Pharmaceutical Products: A Guide to Managing Risks Associated with Cross-Contamination, 2nd ed.; 2017.
- 19.↵
- Fourman G. L.,
- Mullen M. V.
- 20.↵
- Sharnez R.
- 21.↵
- Sharnez R.,
- To A.,
- Klewer L.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 6
November/December 2018
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
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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