APIs and Toxins/Linkers for ADCs: A Vision on Highly Potent Development, Scale-up and Manufacturing

Drug development based on potent compounds can be quite challenging. Complications with the interface between operations in drug substance and drug product handling can result in increased program complexity and cost. This also applies when the potent compound is used as toxin/linker for application in ADCs.  In this presentation, we will elaborate on best practices and requirements that facilitate accelerated timelines to clinic & market: (1) Development, rapid scaling and commercial production of HPAPI drug substance, (2) Integrated containment for particle engineering and drug products, and (3) Impact of supporting integrated service-offerings on expansion strategies.