Work

Impurity qualification requirements for drug-linkers related impurities used to generate antibody-drug conjugates

Year: 2025

Type: review

Source: Regulatory Toxicology and Pharmacology

DOI: 10.1016/j.yrtph.2025.105974

Authors: Osama Chahrour, Paul D. Cornwell, Penny Leavitt, Elizabeth A. Martin, Christina de Zafra, Susanne Glowienke, Angela White, Andrew Teasdale, Bruce Trela, Mayur S. Mitra, Wolfgang Muster, Jim Harvey

Institutions: AstraZeneca (United Kingdom), Eli Lilly (United States), Bristol-Myers Squibb (United States), Pfizer (United States), Novartis (Switzerland), GlaxoSmithKline (United Kingdom), GlaxoSmithKline Research & Development Limited (United Kingdom), AbbVie (United States), Genentech, F. Hoffmann-La Roche AG

Language: English

Topic: Biosimilars and Bioanalytical Methods

Subfield: Immunology

Field: Immunology and Microbiology

Domain: Life Sciences

SDG: Good health and well-being

Open Access status: closed

OpenAlex ID: W4415459686

FWCI: 0.182

Cites: 37

Cited by: 2

Related to: 10