Risk Assessment and Control of <i>N</i>-Nitrosamines in Antibody–Drug Conjugates: Current Industry Practices-Reference-Cited by-同舟云学术

Risk Assessment and Control of N-Nitrosamines in Antibody–Drug Conjugates: Current Industry Practices

Published:2024-07-30 Issue:8 Volume:28 Page:3078-3084
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Bulger Paul G.¹^ORCID,Jones Michael T.²,Ford J. Gair³^ORCID,Schrier Kate⁴,Cole Kevin P.⁵^ORCID,Bernardoni Frank¹,Dirat Olivier⁶,Zhang Qunying⁷,Chahrour Osama⁸^ORCID,Miller Joy⁹,Bonaga Llorente¹⁰,Parsons Andrew T.¹¹^ORCID,Yang Lan⁹

Affiliation:

1. Department of Analytical Research & Development, Merck & Co., Inc., Rahway, New Jersey 07065, United States

2. Pharmaceutical Sciences, Pfizer Inc., Chesterfield, Missouri 63017, United States

3. AstraZeneca, CMC Regulatory Affairs, Charter Way, Macclesfield SK10 2NA, U.K.

4. Small Molecule CMC Regulatory Affairs, Gilead Sciences, Inc., Foster City, California 94404, United States

5. Synthetic Molecule Design and Development, Eli Lilly and Co., Indianapolis, Indiana 46285, United States

6. CMC Advisory Office, Pfizer Global Regulatory Sciences, Sandwich CT13 9NJ, U.K.

7. Analytical Research & Development, AbbVie Inc., North Chicago, Illinois 60064, United States

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

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

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

11. Process Development, Amgen, Inc., Cambridge, Massachusetts 02142, United States

Publisher

American Chemical Society (ACS)

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.4c00254

Reference49 articles.

1. Please visit www.iqconsortium.org for more information.

2. XXIII.—On aromatic nitrosamines

3. Some Toxic Properties of Dimethylnitrosamine

4. The Production of Malignant Primary Hepatic Tumours in the Rat by Feeding Dimethylnitrosamine

5. Estimated Cancer Risks Associated with Nitrosamine Contamination in Commonly Used Medications

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