Nitrosamine Risk Assessments in Oligonucleotides-Reference-Cited by-同舟云学术

Nitrosamine Risk Assessments in Oligonucleotides

Published:2022-12-26 Issue: Volume: Page:
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Borths Christopher J.¹^ORCID,Burr Tracey²,Figuccia Aude³,Ford J. Gair⁴^ORCID,Guan Bing⁵,Jones Michael T.⁶,Klingeleers Didier⁷,Lochner Susanne⁷,Rodriguez Andrew A.²^ORCID,Wetter Christian⁸

Affiliation:

1. Amgen Inc., 360 Binney Street, Cambridge, Massachusetts 02142, United States

2. Ionis Pharmaceuticals Inc., Carlsbad, California 92010, United States

3. Novartis AG, Lichtstrasse 35, CH-4056 Basel, Switzerland

4. AstraZeneca, Macclesfield SK10 2NA, United Kingdom

5. Biogen, Cambridge, Massachusetts 02142, United States

6. Pfizer, 875 Chesterfield Parkway West, Chesterfield, Missouri 63017, United States

7. Janssen, Turnhoutseweg 30, B-2340 Beerse, Belgium

8. F. Hoffmann-La Roche AG, Grenzacherstrasse 124, CH-4070 Basel, Switzerland

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.2c00330

Reference38 articles.

1. European Pharma Oligonucleotide Consortium A Move to Consolidate Oligonucleotide Knowledge and Share Experience Within the Community

2. a Guidance for marketing authorisation holders. European Medicines Agency. https://www.ema.europa.eu/en/human-regulatory/post-authorisation/referral-procedures/nitrosamine-impurities#guidance-for-marketing-authorisation-holders-section (accessed 2022-10-20).

3. b Control of Nitrosamine Impurities in Human Drugs: Guidance for Industry. U.S. Food and Drug Administration, September 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/control-nitrosamine-impurities-human-drugs (accessed 2022-10-20).

4. Guidance on nitrosamine impurities in medications. Health Canada, September 1, 2022. https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/nitrosamine-impurities/medications-guidance.html (accessed 2022-10-20).

5. Workflows for Quality risk management of nitrosamine risks in medicines, ver. 2.0. European Federation of Pharmaceutical Industries and Associations, August 2022. https://www.efpia.eu/media/676632/efpia-nitrosamines-quality-risk-management-workflows-sep-2022.pdf (accessed 2022-10-20).