From Facility to Delivery: Solving the Complex Science of ADC Linker-Payload Synthesis
The rapid growth of antibody-drug conjugate (ADC) programs is creating new challenges for a CDMO execution for highly potent linker-payloads. While containment, limited material availability, and accelerated timelines are well-recognized challenges, successful scale-up and GMP manufacture often depend on solving less frequently discussed problems. These include establishing reference standards when only small quantities of material are available, managing unusual solubility and physical properties associated with increasingly complex and high-molecular-weight linker-payloads, establishing industrial hygiene and cleaning limits, and introducing equipment capable of safely handling highly potent materials without compromising development flexibility or product recovery.
In this webinar, experts from SK pharmteco’s European and North American sites will share practical experience addressing these challenges across the linker-payload development lifecycle—from facility and containment strategy through process and analytical development, scale-up, cleaning, and final product release. Case-based examples will illustrate how integrated chemistry, engineering, analytical, and industrial hygiene strategies can reduce technical risk and support the rapid transition of emerging ADC programs into GMP manufacturing.
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