title: Bioanalysis of antibody-drug conjugates: American Association of Pharmaceutical Scientists Antibody-Drug Conjugate Working Group position paper.
abstract: Antibody-drug conjugates (ADCs) typically consist of a cytotoxic drug covalently bound to an antibody by a linker. These conjugates have the potential to substantially improve efficacy and reduce toxicity compared with cytotoxic small-molecule drugs. Since ADCs are generally complex heterogeneous mixtures of multiple species, these novel therapeutic products present unique bioanalytical challenges. The growing number of ADCs being developed across the industry suggests the need for alignment of the bioanalytical methods or approaches used to assess the multiple species and facilitate consistent interpretation of the bioanalytical data. With limited clinical data, the current strategies that can be used to provide insight into the relationship between the multiple species and the observed clinical safety and efficacy are still evolving. Considerations of the bioanalytical strategies for ADCs based on the current industry practices that take into account the complexity and heterogeneity of ADCs are discussed.
authors: Pfizer, 1 Burtt Road, Andover, MA 01810, USA. boris.gorovits@pfizer.com
authors: Boris
authors: B
authors: Gorovits
authors: Stephen C
authors: SC
authors: Alley
authors: Sanela
authors: S
authors: Bilic
authors: Brian
authors: B
authors: Booth
authors: Surinder
authors: S
authors: Kaur
authors: Phillip
authors: P
authors: Oldfield
authors: Shobha
authors: S
authors: Purushothama
authors: Chetana
authors: C
authors: Rao
authors: Stacy
authors: S
authors: Shord
authors: Patricia
authors: P
authors: Siguenza
mesh_terms: D000911:Antibodies, Monoclonal / Q000032:analysis* / Q000494:pharmacology; D001681:Biological Assay; D006801:Humans; D018796:Immunoconjugates / Q000032:analysis* / Q000494:pharmacology; D004364:Pharmaceutical Preparations / Q000032:analysis*; D058028:Research Report; D014481:United States
chemical_list: D000911:Antibodies, Monoclonal; D018796:Immunoconjugates; D004364:Pharmaceutical Preparations