Risk Evaluation of <i>N</i>-Nitrosamines in Drug-Linker Intermediates Used To Generate Antibody

Risk Evaluation of N-Nitrosamines in Drug-Linker Intermediates Used To Generate Antibody–Drug Conjugates

Published:2024-07-25 Issue:8 Volume:28 Page:3085-3093
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Chahrour Osama¹^ORCID,Bulger Paul G.²^ORCID,Dirat Olivier³,Schrier Kate⁴,Parsons Andrew T.⁵^ORCID,Ford J. Gair⁶^ORCID,Bernardoni Frank²,Hetrick Evan M.⁷,Bonaga Llorente R.⁸,Cole Kevin P.⁷^ORCID,Miller Joy⁹,Zhang Qunying¹⁰,Jones Michael T.¹¹

Affiliation:

1. Chemical Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield SK10 2NA, U.K.

2. Department of Analytical Research & Development, Merck & Co., Inc., 126 East Lincoln Avenue, Rahway, New Jersey 07065, United States

3. Pfizer Global Regulatory Sciences, CMC Advisory Office, Sandwich CT13 9NJ, United Kingdom

4. CMC Regulatory Affairs, Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, California 94404, United States

5. Process Development, Amgen, Inc., 360 Binney Street, Cambridge, Massachusetts 02142, United States

6. CMC Regulatory Affairs, AstraZeneca, Macclesfield SK10 2NA, U.K.

7. Lilly Research Laboratories, Eli Lilly & Co., Lilly Corporate Center, Indianapolis, Indiana 46285, United States

8. GRACS CMC, Merck & Co., Inc., 126 East Lincoln Avenue, Rahway, New Jersey 07065, United States

9. Analytical Development, Takeda Pharmaceuticals, 200 Shire Way, Lexington, Massachusetts 02421, United States

10. Analytical Research & Development, AbbVie Inc., 1 North Waukegan Road, North Chicago, Illinois 60064, United States

11. Pharmaceutical Sciences, Pfizer Inc., 875 Chesterfield Parkway West, Chesterfield, Missouri 63017, United States

Publisher

American Chemical Society (ACS)

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.4c00255

Reference38 articles.

1. aEuropean Medicines Agency EMA/369136/2020. Assessment Report – Procedure under Article 5(3) of Regulation EC (No) 726/2004: Nitrosamine Impurities in Human Medicinal Products, 2020.

2. bEuropean Medicines Agency EMA/409815/2020 Rev.20. Questions and Answers for Marketing Authorization Holders/Applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 Referral on Nitrosamine Impurities in Human Medicinal Products, 2024.

3. aUS FDA Control of Nitrosamine Impurities in Human Drugs, Revision 1, 2021.

4. bUS FDA. Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs) - Guidance for Industry, 2023.

5. N-Nitrosamine Impurities in Biological Medicinal Products. European Federation of Pharmaceutical Industries and Associations, 2020. Https://Www.Efpia.Eu/Media/580595/n-Nitrosamine-Impurities-in-Biological-Medicinal-Products.Pdf (accessed Dec 20, 2023).

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1. Risk Assessment and Control of N-Nitrosamines in Antibody–Drug Conjugates: Current Industry Practices;Organic Process Research & Development;2024-07-30