Antibody-drug conjugates (ADC) are a new type of therapeutic medication used to treat tumors. They are produced by combining monoclonal antibodies with extremely poisonous substances via linkers. As of the conclusion of 2022, there have been a cumulative total of 15 internationally licensed ADCs, with 10 of them receiving approval since 2019. This has sparked a resurgence in the development of ADCs. An antibody-drug conjugate (ADC) is composed of three essential elements: the antibody, the cytotoxic payload, as well as the linker that connects the antibody to the payload. Two crucial criteria contribute to the effective development of innovative ADCs: An ideal ADC should exhibit stability in the bloodstream and specifically target tumor cells, resulting in the prompt releasing of the ADC payload upon internalization by the tumor cells. Inadequate hemodynamic stability or excessive systemic distribution can lead to significant toxicity of ADCs. Furthermore, the payload discharged by an ADC within tumor cells must possess high cytotoxicity in order to rapidly eliminate tumor cells.
Assessment of ADC PK:
Pharmacokinetics illustrates a drug’s efficacy based on its absorption, dispersion, metabolism, and disposal. Traditional pharmacokinetics involves monitoring the medication and/or metabolites in its circulatory blood stream at various times. From a pharmacokinetic standpoint, the development of ADCs has two distinct features. Initially, the ADC pk study presents significant difficulties. Due to being a new medication, there is a lack of comprehensive knowledge regarding the pharmacokinetic features of ADCs in humans throughout the business. As of now, there have been no research undertaken on the mass balance of ADCs using radiolabeling in humans. ADC, or antibody-drug conjugate, consists of both macroscopic and microscopic compounds, thus requiring a thorough investigation into the pharmacokinetics of all these distinct entities. Moreover, a thorough understanding of the release and metabolism of the ADC payload is crucial for the advancement of ADC development. More precisely, the effectiveness of ADCs is directly linked to the controlled delivery and concentration of these payloads in the intended organs, whereas the release of payloads in unintended tissues is entirely linked to the potential toxicity of ADCs. Furthermore, the Drug-Drug Interaction (DDI) of ADC is linked to the levels of metabolism, exposure, and release of the payload ADC PK study.
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