Abstract:
Undoubtedly the complexity of Antibody Drug Conjugate (ADC) molecules where three components (monoclonal antibody, cytotoxic drug and appropriate linker) are involved poses a challenge for biosimilar development. As with all biomolecule development, both novel and biosimilar, it is important to choose orthogonal analytical techniques to interrogate Quality Attributes, particularly for Higher Order Structure (HOS) studies and investigations into possible aggregates. Examples of suitable techniques are described.

Submitted: 27 June 2023; Revised: 1 August 2023; Accepted: 23 August 2023; Published online first: 5 September 2023

Antibody Drug Conjugates (ADCs) are antibody-based anti-cancer therapeutics consisting of monoclonal antibodies attached to a cytotoxic drug via a linker of some kind. These highly targeted delivery systems offer the promise of lower cytotoxic drug levels in the patient and, as a result, potentially reduced drug side-effects [1].

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This manuscript has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record.