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In silico assessment of biomolecule reactivity with leachables

Candice Johnson, Douglas Kiehl, Piet Christiaens, Ferran Sancho Jodar, Ruud Cuyvers, Arianna Bassan, Lisa Beilke, Joel P Bercu, Thomas Costelloe, Kevin P Cross, Andrew Feilden, Ron Filler, Maria Fátima Lucas, Melisa J Masuda-Herrera, Mona Moghimi, Nick Morley, Diane Paskiet, Manuela Pavan, Julia Pletz, M. Vijayaraj Reddy, Christopher J Waine and Glenn J Myatt
PDA Journal of Pharmaceutical Science and Technology December 2023, pdajpst.2022.012818; DOI: https://doi.org/10.5731/pdajpst.2022.012818
Candice Johnson
1 Instem;
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Douglas Kiehl
2 Eli Lilly and Company;
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Piet Christiaens
3 Nelson Labs;
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  • For correspondence: pchristiaens@nelsonlabs.com
Ferran Sancho Jodar
4 Zymvol Biomodeling;
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  • For correspondence: fsancho@zymvol.com
Ruud Cuyvers
4 Zymvol Biomodeling;
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  • For correspondence: rcuyvers@nelsonlabs.com
Arianna Bassan
5 Innovatune;
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  • For correspondence: arianna.bassan@innovatune.com
Lisa Beilke
6 Toxicology Solutions, Inc.;
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  • For correspondence: lisa@toxsolutionsinc.com
Joel P Bercu
7 Gilead Sciences;
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Thomas Costelloe
8 IMIHGOM B.V.;
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  • For correspondence: tcostelloe@imihgom.com
Kevin P Cross
1 Instem;
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Andrew Feilden
9 BicycleTx Ltd;
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  • For correspondence: andrew.feilden@bicycletx.com
Ron Filler
10 Drug Development Consultants, LLC;
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Maria Fátima Lucas
4 Zymvol Biomodeling;
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  • For correspondence: flucas@zymvol.com
Melisa J Masuda-Herrera
7 Gilead Sciences;
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  • For correspondence: melisa.masuda-herrera@gilead.com
Mona Moghimi
8 IMIHGOM B.V.;
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Nick Morley
11 Element Materials Technology;
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Diane Paskiet
12 West Pharmaceutical Services;
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Manuela Pavan
5 Innovatune;
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Julia Pletz
13 Exponent International Ltd.;
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M. Vijayaraj Reddy
14 Merck & Co., Inc.;
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  • For correspondence: vijay.reddy@merck.com
Christopher J Waine
15 Bibra Toxicology Advice and Consulting
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Glenn J Myatt
1 Instem;
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Article Information

pdajpst.2022.012818
DOI 
https://doi.org/10.5731/pdajpst.2022.012818
PubMed 
38942477

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Received December 15, 2022
  • Accepted December 5, 2023
  • Published online December 19, 2023.

Article Versions

  • You are currently viewing a previous version of this article (December 19, 2023 - 03:26).
  • View the most recent version of this article
Copyright & Usage 
Copyright © 2023, Parenteral Drug Association

Author Information

  1. Candice Johnson1 (candice.johnson{at}instem.com),
  2. Douglas Kiehl2 (kiehl_douglas_e{at}lilly.com),
  3. Piet Christiaens3 (pchristiaens{at}nelsonlabs.com),
  4. Ferran Sancho Jodar4 (fsancho{at}zymvol.com),
  5. Ruud Cuyvers4 (rcuyvers{at}nelsonlabs.com),
  6. Arianna Bassan5 (arianna.bassan{at}innovatune.com),
  7. Lisa Beilke6 (lisa{at}toxsolutionsinc.com),
  8. Joel P Bercu7 (joel.bercu{at}gilead.com),
  9. Thomas Costelloe8 (tcostelloe{at}imihgom.com),
  10. Kevin P Cross1 (kevin.cross{at}instem.com),
  11. Andrew Feilden9 (andrew.feilden{at}bicycletx.com),
  12. Ron Filler10 (ron.filler{at}drugdevelopmentconsultants.com),
  13. Maria F&aacutetima Lucas4 (flucas{at}zymvol.com),
  14. Melisa J Masuda-Herrera7 (melisa.masuda-herrera{at}gilead.com),
  15. Mona Moghimi8 (mmoghimi{at}imihgom.com),
  16. Nick Morley11 (nick.morley{at}element.com),
  17. Diane Paskiet12 (diane.paskiet{at}westpharma.com),
  18. Manuela Pavan5 (manuela.pavan{at}innovatune.com),
  19. Julia Pletz13 (jpletz{at}exponent.com),
  20. M. Vijayaraj Reddy14 (vijay.reddy{at}merck.com),
  21. Christopher J Waine15 (chris.waine{at}bibratoxadvice.co.uk) and
  22. Glenn J Myatt1,16 (glenn.myatt{at}instem.com)
  1. 1 Instem;
  2. 2 Eli Lilly and Company;
  3. 3 Nelson Labs;
  4. 4 Zymvol Biomodeling;
  5. 5 Innovatune;
  6. 6 Toxicology Solutions, Inc.;
  7. 7 Gilead Sciences;
  8. 8 IMIHGOM B.V.;
  9. 9 BicycleTx Ltd;
  10. 10 Drug Development Consultants, LLC;
  11. 11 Element Materials Technology;
  12. 12 West Pharmaceutical Services;
  13. 13 Exponent International Ltd.;
  14. 14 Merck & Co., Inc.;
  15. 15 Bibra Toxicology Advice and Consulting
  1. ↵* Corresponding author; email: glenn.myatt{at}instem.com

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PDA Journal of Pharmaceutical Science and Technology: 79 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 3
May/June 2025
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In silico assessment of biomolecule reactivity with leachables
Candice Johnson, Douglas Kiehl, Piet Christiaens, Ferran Sancho Jodar, Ruud Cuyvers, Arianna Bassan, Lisa Beilke, Joel P Bercu, Thomas Costelloe, Kevin P Cross, Andrew Feilden, Ron Filler, Maria F&aacutetima Lucas, Melisa J Masuda-Herrera, Mona Moghimi, Nick Morley, Diane Paskiet, Manuela Pavan, Julia Pletz, M. Vijayaraj Reddy, Christopher J Waine, Glenn J Myatt
PDA Journal of Pharmaceutical Science and Technology Dec 2023, pdajpst.2022.012818; DOI: 10.5731/pdajpst.2022.012818

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In silico assessment of biomolecule reactivity with leachables
Candice Johnson, Douglas Kiehl, Piet Christiaens, Ferran Sancho Jodar, Ruud Cuyvers, Arianna Bassan, Lisa Beilke, Joel P Bercu, Thomas Costelloe, Kevin P Cross, Andrew Feilden, Ron Filler, Maria F&aacutetima Lucas, Melisa J Masuda-Herrera, Mona Moghimi, Nick Morley, Diane Paskiet, Manuela Pavan, Julia Pletz, M. Vijayaraj Reddy, Christopher J Waine, Glenn J Myatt
PDA Journal of Pharmaceutical Science and Technology Dec 2023, pdajpst.2022.012818; DOI: 10.5731/pdajpst.2022.012818
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Keywords

  • Biomolecule active pharmaceutical ingredients
  • Computational methods
  • Covalent interaction
  • Extractables and leachables 
  • Monoclonal antibodies
  • Predictive methods

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