Open AccessBioanalysis of antibody–drug conjugates: American Association of Pharmaceutical Scientists Antibody–Drug Conjugate Working Group position paper
Author(s) -
Boris Gorovits,
Stephen C. Alley,
Sanela Bilic,
Brian Booth,
Surinder Kaur,
Phillip Oldfield,
Shobha Purushothama,
Chetana Rao,
Stacy S. Shord,
Patricia Siguenza
Publication year - 2013
Publication title -
bioanalysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.566
H-Index - 58
eISSN - 1757-6199
pISSN - 1757-6180
DOI - 10.4155/bio.13.38
Subject(s) - bioanalysis , antibody drug conjugate , conjugate , drug , linker , pharmacology , pharmaceutical industry , computational biology , computer science , chemistry , combinatorial chemistry , nanotechnology , medicine , antibody , monoclonal antibody , biology , chromatography , mathematics , materials science , immunology , mathematical analysis , operating system
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.