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Title

Is hydrophobic interaction chromatography the most suitable technique to characterize site-specific antibody-drug conjugates?
Authors
D'Atri, Valentina
Pell, Reinhard
Clarke, Adrian
Guillarme, Davy
Fekete, Szabolcs
Published in Journal of chromatography. 2019, vol. 1586, p. 149-153
Abstract Antibody drug conjugates (ADCs) belong to the fastest growing class of therapeutic agents for cancer therapy. In preclinical and clinical studies, there is a significant number of site-specific ADCs (also known as third generation ADCs), which are more homogeneous than their previous generations. These new ADC formats, in which the inter-chain disulphide bridges (hinge cysteines) are not reduced, also need to be deeply characterized. In particular, various quality attributes (QAs) have to be determined, such as free antibody level, average drug to antibody ratio (DAR) and drug distribution. In this contribution, a non-commercial site-specific conjugated ADC has been analyzed by RPLC. Our results demonstrated that RPLC has a huge potential to determine QAs and can replace the historically used HIC methods as RPLC provides better separation quality for such type of ADCs. Site-specific ADCs can be analyzed in RPLC at intact level without the need for sample preparation. A further advantage of RPLC is that it enables the direct coupling to MS and thus allows the fine identification of all eluting species.
Keywords Site-specific antibody drug conjugates — Hydrophobic interaction chromatography — Reversed phase liquid chromatography — Mass spectrometry — Biopharmaceuticals
Identifiers
PMID: 30554777
Full text
Article (Published version) (749 Kb) - document accessible for UNIGE members only Limited access to UNIGE
Other version: https://linkinghub.elsevier.com/retrieve/pii/S0021967318315279
Structures
Faculté des sciences / Section des sciences pharmaceutiques
Research group Sciences analytiques
Citation
(ISO format) 		D'ATRI, Valentina et al. Is hydrophobic interaction chromatography the most suitable technique to characterize site-specific antibody-drug conjugates?. In: Journal of Chromatography. A, 2019, vol. 1586, p. 149-153. doi: 10.1016/j.chroma.2018.12.020 https://archive-ouverte.unige.ch/unige:115543

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Deposited on : 2019-04-01

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