Research ArticleResearch
Development of Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTCs) Relevant to Parenteral Extractables and Leachables (E&Ls)
Melisa J. Masuda-Herrera, Joel P. Bercu, Thomas H. Broschard, Anders Burild, Catrin Hasselgren, Patricia Parris, Lucie C. Ford, Jessica Graham, Brad Stanard, Michele Comerford, Daniel Lettiere, Steffen Erler, Courtney M. Callis, Eric Morinello, Wolfgang Muster, Elizabeth A. Martin, Troy R. Griffin, Lee Nagao and Maureen Cruz
PDA Journal of Pharmaceutical Science and Technology September 2022, 76 (5) 369-383; DOI: https://doi.org/10.5731/pdajpst.2021.012693
Melisa J. Masuda-Herrera
1Nonclinical Safety and Pathobiology (NSP), Gilead Sciences, Inc., Foster City, CA, USA;
Joel P. Bercu
1Nonclinical Safety and Pathobiology (NSP), Gilead Sciences, Inc., Foster City, CA, USA;
Thomas H. Broschard
2Merck Healthcare KGaA, Frankfurter Str. 250, 64293 Darmstadt, Germany;
Anders Burild
3Safety Sciences, Imaging and Data Management, Novo Nordisk A/S, Novo Nordisk Park 2760 Måløv, Denmark;
Catrin Hasselgren
4Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080;
Patricia Parris
5Pfizer Worldwide Research and Development, Sandwich, United Kingdom;
Lucie C. Ford
6Department of Veterinary Integrative Biosciences, Interdisciplinary Faculty of Toxicology Program, Texas A&M University, 4466 TAMU, College Station, TX, 77843-4466;
Jessica Graham
4Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080;
Brad Stanard
7Ultragenyx Pharmaceutical Inc., Novato, CA;
Michele Comerford
8Pfizer Global Research & Development, Groton, CT, 06340;
Daniel Lettiere
8Pfizer Global Research & Development, Groton, CT, 06340;
Steffen Erler
9Wella Company, Berliner Allee 65, 64295 Darmstadt, Germany;
Courtney M. Callis
10Lilly Research Laboratories, Eli Lilly & Company, Indianapolis, IN;
Eric Morinello
4Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080;
Wolfgang Muster
11Roche Pharmaceutical Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center, Basel, Switzerland;
Elizabeth A. Martin
12Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Cambridge, United Kingdom;
Troy R. Griffin
13Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, 19380; and
Lee Nagao
14Faegre Drinker Biddle & Reath LLP, Washington, DC
Maureen Cruz
14Faegre Drinker Biddle & Reath LLP, Washington, DC
References
- 1.↵
- 2.↵
- Jenke D.,
- Castner J.,
- Egert T.,
- Feinberg T.,
- Hendricker A.,
- Houston C.,
- Hunt D. G.,
- Lynch M.,
- Shaw A.,
- Nicholas K.,
- Norwood D. L.,
- Paskiet D.,
- Ruberto M.,
- Smith E. J.,
- Holcomb F.
- 3.↵
- Jenke D. R.
- 4.↵
- Jenke D. R.
- 5.↵
- Jenke D. R,
- Story J.,
- Lalani R.
- 6.↵
- Li K.,
- Rogers G.,
- Nashed-Samuel Y.,
- Lee H.,
- Mire-Sluis A.,
- Cherney B.,
- Forster R.,
- Yeh P.,
- Markovic I.
- 7.↵
- Paskiet D.,
- Jenke D.,
- Ball D.,
- Houston C.,
- Norwood D. L.,
- Markovic I.
- 8.↵International Conference for Harmonisation, Final Concept Paper ICH Q3E: Guideline for Extractables and Leachables (E&Ls). ICH: Geneva, 2020.
- 9.↵U.S. Food and Drug Administration, Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics; FDA-1997-D-0145; Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 1999.
- 10.↵
- Broschard T. H.,
- Glowienke S.,
- Bruen U. S.,
- Nagao L. M.,
- Teasdale A.,
- Stults C. L. M.,
- Li K. L.,
- Iciek L. A.,
- Erexson G.,
- Martin E. A.,
- Ball D. J.
- 11.↵
- Parris P.,
- Martin E. A.,
- Stanard B.,
- Glowienke S.,
- Dolan D. G.,
- Li K.,
- Binazon O.,
- Giddings A.,
- Whelan G.,
- Masuda-Herrera M.,
- Bercu J.,
- Broschard T.,
- Bruen U.,
- Callis C. M.,
- Stults C. L. M.,
- Erexson G. L.,
- Cruz M. T.,
- Nagao L. M.
- 12.↵
- Munro I. C.,
- Ford R. A.,
- Kennepohl E.,
- Sprenger J. G.
- 13.↵
- Kroes R.,
- Renwick A. G.,
- Cheeseman M.,
- Kleiner J.,
- Mangelsdorf I.,
- Piersma A.,
- Schilter B.,
- Schlatter J.,
- van Schothorst F.,
- Vos J. G.,
- Würtzen G.
- 14.↵
- Bury D.,
- Head J.,
- Keller D.,
- Klaric M.,
- Rose J.
- 15.↵
- Dolan D. G.,
- Naumann B. D.,
- Sargent E. V.,
- Maier A.,
- Dourson M.
- 16.↵
- Stanard B.,
- Dolan D. G.,
- Hanneman W.,
- Legare M.,
- Bercu J. P.
- 17.↵
- Kawamoto T.,
- Fuchs A.,
- Fautz R.,
- Morita O.
- 18.↵International Conference for Harmonisation, Harmonised Guideline M7(R1): Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. ICH: Geneva, 2017.
- 19.↵
- Felter S. P.,
- Conolly R. B.,
- Bercu J. P.,
- Bolger P. M.,
- Boobis A. R.,
- Bos P. M.,
- Carthew P.,
- Doerrer N. G.,
- Goodman J. I.,
- Harrouk W. A.,
- Kirkland D. J.,
- Lau S. S.,
- Llewellyn G. C.,
- Preston R. J.,
- Schoeny R.,
- Schnatter A. R.,
- Tritscher A.,
- van Velsen F.,
- Williams G. M.
- 20.↵
- Amberg A.,
- Beilke L.,
- Bercu J.,
- Bower D.,
- Brigo A.,
- Cross K. P.,
- Custer L.,
- Dobo K.,
- Dowdy E.,
- Ford K. A.,
- Glowienke S.,
- Van Gompel J.,
- Harvey J.,
- Hasselgren C.,
- Honma M.,
- Jolly R.,
- Kemper R.,
- Kenyon M.,
- Kruhlak N.,
- Leavitt P.,
- Miller S.,
- Muster W.,
- Nicolette J.,
- Plaper A.,
- Powley M.,
- Quigley D. P.,
- Reddy M. V.,
- Spirkl H.-P.,
- Stavitskaya L.,
- Teasdale A.,
- Weiner S.,
- Welch D. S.,
- White A.,
- Wichard J.,
- Myatt G. J.
- 21.↵
- Barber C.,
- Amberg A.,
- Custer L.,
- Dobo K. L.,
- Glowienke S.,
- Van Gompel J.,
- Gutsell S.,
- Harvey J.,
- Honma M.,
- Kenyon M. O.,
- Kruhlak N.,
- Muster W.,
- Stavitskaya L.,
- Teasdale A.,
- Vessey J.,
- Wichard J.
- 22.↵
- Paskiet D.
- 23.↵International Organization for Standardization, IS/TS 21726:2019 Biological Evaluation of Medical Devices—Application of the Threshold of Toxicological Concern (TTC) for Assessing Biocompatibility of Medical Device Constituents. ISO: Geneva, 2019.
- 24.↵International Conference for Harmonisation, Harmonised Guideline Q3C(R8): Impurities: Guideline for Residual Solvents. ICH: Geneva, 2021.
- 25.↵International Conference for Harmonisation, ICH M3(R2): Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. ICH: Geneva, 2009.
- 26.↵
- Sussman R. G.,
- Naumann B. D.,
- Pfister T.,
- Sehner C.,
- Seaman C.,
- Weideman P. A.
- 27.↵
- Nelms M. D,
- Pradeep P.,
- Patlewicz G.
- 28.↵KNIME, 2021.
- 29.↵
- Landrum G.
- 30.↵
- 31.↵International Conference for Harmonisation, Harmonised Guideline Q3D(R1): Guideline for Elemental Impurities. ICH: Geneva, 2019.
- 32.↵
- Harvey J.,
- Fleetwood A.,
- Ogilvie R.,
- Teasdale A.,
- Wilcox P.,
- Spanhaak S.
- 33.↵
- 34.↵
- Partosch F.,
- Mielke H.,
- Stahlmann R.,
- Kleuser B.,
- Barlow S.,
- Gundert-Remy U.
- 35.↵
- Parris P.
- 36.↵United Nations. Globally Harmonized System of Classification and Labelling of Chemicals (GHS), 8th revised ed.; United Nations: New York, 2019.
- 37.↵
- Lampe B. J.,
- Fuller E.,
- Kuppusamy S. P.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 76, Issue 5
September/October 2022
Development of Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTCs) Relevant to Parenteral Extractables and Leachables (E&Ls)
Melisa J. Masuda-Herrera, Joel P. Bercu, Thomas H. Broschard, Anders Burild, Catrin Hasselgren, Patricia Parris, Lucie C. Ford, Jessica Graham, Brad Stanard, Michele Comerford, Daniel Lettiere, Steffen Erler, Courtney M. Callis, Eric Morinello, Wolfgang Muster, Elizabeth A. Martin, Troy R. Griffin, Lee Nagao, Maureen Cruz
PDA Journal of Pharmaceutical Science and Technology Sep 2022, 76 (5) 369-383; DOI: 10.5731/pdajpst.2021.012693
Development of Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTCs) Relevant to Parenteral Extractables and Leachables (E&Ls)
Melisa J. Masuda-Herrera, Joel P. Bercu, Thomas H. Broschard, Anders Burild, Catrin Hasselgren, Patricia Parris, Lucie C. Ford, Jessica Graham, Brad Stanard, Michele Comerford, Daniel Lettiere, Steffen Erler, Courtney M. Callis, Eric Morinello, Wolfgang Muster, Elizabeth A. Martin, Troy R. Griffin, Lee Nagao, Maureen Cruz
PDA Journal of Pharmaceutical Science and Technology Sep 2022, 76 (5) 369-383; DOI: 10.5731/pdajpst.2021.012693