Control of Mutagenic Impurities: Survey of Pharmaceutical Company Practices and a Proposed Framework for Industry Alignment-Reference-Cited by-同舟云学术

Control of Mutagenic Impurities: Survey of Pharmaceutical Company Practices and a Proposed Framework for Industry Alignment

Published:2021-03-03 Issue:4 Volume:25 Page:831-837
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Borths Christopher J.¹^ORCID,Argentine Mark D.²,Donaubauer John³,Elliott Eric L.⁴,Evans Jared⁵,Kramer Timothy Talbot²,Lee Heewon⁶,Parsons Rodney⁷,Roberts Jeffrey C.²,Sluggett Gregory W.⁸,Teasdale Andrew⁹,Urquhart Michael¹⁰^ORCID,Wang Ke⁸^ORCID,Zhuang Ping¹¹

Affiliation:

1. Drug Substance Technologies, Amgen, Inc., Cambridge, Massachusetts 02142, United States

2. Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285, United States

3. AbbVie, North Chicago, Illinois 60064, United States

4. Takeda Pharmaceuticals, 35 Landsdowne Street, Cambridge, Massachusetts 02139, United States

5. Gilead Sciences, Foster City, California 94404, United States

6. Chemical Development, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut 06877, United States

7. Chemical Process Development, Bristol-Myers Squibb Co., New Brunswick, New Jersey 08903, United States

8. Analytical Research & Development, Pfizer, Inc., Easter Point Road, Groton, Connecticut 06340, United States

9. AstraZeneca, Macclesfield, Cheshire SK10 4TG, U.K.

10. Chemical Development, GlaxoSmithKline Pharmaceuticals, Kent TN11 9AN, U.K.

11. Analytical Research & Development, Merck & Co., Inc., Rahway, New Jersey 07065, United States

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.0c00517

Reference16 articles.

1. Mutagenic Impurities: Precompetitive/Competitive Collaborative and Data Sharing Initiatives

2. Strategies To Address Mutagenic Impurities Derived from Degradation in Drug Substances and Drug Products

3. Mutagenic Alkyl-Sulfonate Impurities in Sulfonic Acid Salts: Reviewing the Evidence and Challenging Regulatory Perceptions

4. Mechanisms of Chemical Carcinogenicity and Mutagenicity: A Review with Implications for Predictive Toxicology

5. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. Guideline, 2017. https://database.ich.org/sites/default/files/M7_R1_Guideline.pdf.

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