Over 180 ADCs are currently in clinical trials and at least 50 biopharmaceutical companies are operating ADC development programs, with the market expected to grow from US$2-3bn in 2021 to US$13bn in 2026, according to a Kuick Research report.
Despite the projected growth of ADCs beyond oncology and into treatments for other diseases, their development faces key data management issues, said Joe DiMartino, who manages a software platform called Luminata, at ACD/Labs.
ADC/Labs, he said, wants to determine how pharma companies manage their data, how they view their data, and what systems are in place when something in the development process goes askew.
Its software tool, which now has enhanced functionality, supports ADC development from the initial establishment of the most advantageous combination of ADC components through optimization of the conjugation and purification process, characterization of the final product and process intermediates, and understanding how process changes impact the impurity profile and efficacy of the product.
Molecular complexity
Although some ADCs involve a direct linkage between the antibody component and the drug, it is far more common for an ADC to consist of three main structural units: a monoclonal antibody (mAb), a small molecule drug – the payload – and a linker covalently connecting the mAb to the payload.
Due to their molecular complexity, ADCs require a number of analytical techniques to characterize their structures, drug antibody ratios (DARs), and impurity profiles, according to DiMartino.