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

  1. 1.↵
    1. Sharnez R.,
    2. Lathia J.,
    3. Kahlenberg D.,
    4. Prabhu S.,
    5. Dekleva M.
    In Situ Monitoring of Soil Dissolution Dynamics: A Rapid and Simple Method for Determining Worst-Case Soils for Cleaning Validation. PDA J. Pharm. Sci. Technol. 2004, 58 (4), 203–214.
    OpenUrlAbstract/FREE Full Text
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    1. Canhoto A.
    A Novel Bench Scale Apparatus to Model and Develop Biopharmaceutical Cleaning Procedures. Journal of Validation Technology, 2004, 11 (4).
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    1. Sharnez R.,
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    Experimental Parameters for Cleaning Characterization; Part I: Dilution of Process Fluids during Cleaning. Journal of Validation Technology, 2013, 19 (3).
  4. 4.↵
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    Experimental Parameters for Cleaning Characterization; Part II: Effect of Fluid Velocity on the Kinetics of Cleaning. Journal of Validation Technology, 2015, 21 (1).
  5. 5.↵
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    Cleaning Agents for Biopharmaceutical Manufacturing. Genetic Engineering News, 2003, 23 (6).
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    1. Sharnez R.,
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    Strategies for Developing a Robust Cleaning Process—Part II: Demonstrating Cycle Effectiveness, American Pharmaceutical Review—Digital Edition, 2012, 15 (3).
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    1. Sharnez R.,
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    Quality-by-Design for Cleaning Validation. Cleaning and Cleaning Validation; Davis Healthcare International & PDA, 2009; Vol. 1, Chapter 6.
  10. 10.↵
    1. Sharnez R.
    Master Soils for Cleaning Cycle Development and Validation: A Case Study, Cleaning and Cleaning Validation; Davis Healthcare International & PDA, 2012; Vol. 2, Chapter 9, pp 191-200.
    OpenUrl
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    1. Sharnez R.
    Leveraging Small-Scale Models to Streamline Validation. Journal of Validation Technology, 2008, 14 (4).
  12. 12.↵
    1. Hale G.,
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    Repeated Cleaning of Protein A Affinity Column with Sodium Hydroxide. Journal of Immunological Methods, 1994, 171 (1), 15–21.
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    1. Mahajan E.,
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    One Resin, Multiple Products: A Green Approach to Purification. Developments in Biotechnology and Bioprocessing, ACS Symposium Series, 2013; Vol. 1125, Chapter 6, pp 87-111.
    OpenUrl
  14. 14.↵
    1. Sharnez R.,
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    Strategies for Setting Rational MAC-based Limits—Part III: Leveraging Toxicology and Cleanability Data. Journal of Validation Technology, 2011, 17 (3), 24–28.
    OpenUrl
  15. 15.↵
    1. Sharnez R.,
    2. Bussiere J.,
    3. Mytych D.,
    4. Spencer A.,
    5. To A.,
    6. Tholudur A.
    Acceptance Limits for Inactivated Product Based on Gelatin as a Reference Impurity. Journal of Validation Technology, 2013, 19 (1).
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    1. Sharnez R.,
    2. et al
    . Methodology for Assessing Product Inactivation During Cleaning. Journal of Validation Technology, 2012, 18 (4), 42–45.
    OpenUrl
  17. 17.↵
    1. Kendrick K.,
    2. Canhoto A.,
    3. Kreuze M.
    Analysis of Degradation Properties of Biopharmaceutical Active Ingredients as Caused by Various Process Cleaning Agents and Temperature. Journal of Validation Technology, 2009, 15 (3), 69.
    OpenUrl
  18. 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. 19.↵
    1. Fourman G. L.,
    2. Mullen M. V.
    Determining Cleaning Validation Acceptance Limits for Pharmaceutical Manufacturing Operations. Pharmaceutical Technology, 1993, 17 (4), 54–60.
    OpenUrl
  20. 20.↵
    1. Sharnez R.
    Unpublished work.
  21. 21.↵
    1. Sharnez R.,
    2. To A.,
    3. Klewer L.
    Strategies for Setting Rational MAC-based Limits—Part II: Application to Rinse Samples. Journal of Validation Technology, 2011, 17 (2), 43–46.
    OpenUrl
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PDA Journal of Pharmaceutical Science and Technology: 72 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 6
November/December 2018
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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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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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  • Article
    • Abstract
    • 1. Introduction
    • 2. Resin, Column, and System Performance
    • 3. Cleaning Cycle Development
    • 4. Evaluating Cleaning Effectiveness
    • 5. Conclusion
    • Conflict of Interest Declaration
    • Acknowledgement
    • Appendix
    • Reference
  • Figures & Data
  • References
  • Info & Metrics
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Keywords

  • Chromatography
  • Multiproduct resin reuse
  • Biopharmaceutical cleaning validation

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