Determination of Purge Factors for Use in Oligonucleotide Control Strategies-Reference-Cited by-同舟云学术

Determination of Purge Factors for Use in Oligonucleotide Control Strategies

Published:2022-03-30 Issue:4 Volume:26 Page:1130-1144
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Fillon Yannick A.¹^ORCID,Akhtar Nadim²,Andrews Benjamin I.³^ORCID,Benstead David²,Breitler Simon⁴,Gronke Robert S.¹,Olbrich Martin⁴,Stolee Jessica A.¹,Vandermeersch Tobias⁵

Affiliation:

1. Biogen Inc., 225 Binney Street, Cambridge, Massachusetts 02142, United States

2. AstraZeneca, Macclesfield SK10 2NA, U.K.

3. GlaxoSmithKline Medicines Research Centre, Gunnels Wood Road, Stevenage SG1 2NY, U.K.

4. F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, 4070 Basel, Switzerland

5. Janssen pharmaceuticals, Turnhoutseweg 30, 2340 Beerse, Belgium

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.1c00398

Reference34 articles.

1. ICH harmonized guideline on impurities in new drug substances Q3A(R2). https://database.ich.org/sites/default/files/Q3A%28R22%29%20Guideline.pdf, 2006.

2. ICH harmonized guideline on Impurities: guidlines for residual solvents Q3C(R8). https://database.ich.org/sites/default/files/ICH_Q3C-R8_Guideline_Step4_2021_0422_2021.pdf, 2021.

3. ICH harmonized guideline on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk M7(R1). https://database.ich.org/sites/default/files/M7_R1_Guideline.pdf, 2018.

4. ICH harmonized guideline on elemental impurities Q3D(R1). https://database.ich.org/sites/default/files/Q3D-R1EWG_Document_Step4_Guideline_2019_0322.pdf, 2019.

5. A Tool for the Semiquantitative Assessment of Potentially Genotoxic Impurity (PGI) Carryover into API Using Physicochemical Parameters and Process Conditions

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