In this webinar, experts from SK pharmteco’s European and North American sites 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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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.
Featured Speakers
John has extensive experience in developing and scaling synthetic routes for APIs and pharmaceutical intermediates, as well as manging their GMP manufacturing across all clinical and commercial stages—from 5 L kilo batches to 4,000 gallon commercial campaigns. John plays a key role in transferring existing commercial synthetic processes to fixed assets and in developing scalable processes from medicinal chemistry routes.
John holds a Ph.D. in Organic Chemistry and a BS in Biochemistry and Molecular Biology from University of California, Davis.
Ryan leads a team of Process Research and Development engineers focused on developing equipment, technologies, and scalable solutions for continuous processing. He manages programs with specialized technology requirements, advancing them through demonstration, scale-up, and validation. Since joining SK pharmteco in 2014, Ryan has played a key role in translating laboratory concepts into robust plant-scale processes. His work has included batch and continuous chromatography separations, crystallization, liquid-liquid extraction, and other advanced purification technologies.
Ryan earned a bachelor’s degree in Chemical Engineering and a Ph.D. in Chemistry from the University of California, Davis.
He has over 13 years of experience in the ADC and HPAPI space, spanning drug-linker design, preclinical ADC evaluation, process development, and clinical and commercial manufacturing. In his current role, Andrew has supported the expansion of drug-linker development and manufacturing capabilities at SK pharmteco Small Molecule Europe. He has authored several peer-reviewed publications on ADC drug-linker design and is an inventor on a patent in this area.
Andrew holds a DPhil in Organic Chemistry from the University of Oxford.
With more than 25 years of experience in drug development and quality control, Alan has extensive knowledge of GMP quality systems, analytical chemistry, laboratory operations, and regulatory compliance. Alan has led initiatives to modernize laboratory operations through digitalization, advanced analytical technologies, and continuous improvement.
Alan earned a bachelor’s degree in Chemistry from Colby College.
