Simplifying the Antibody Drug Conjugate Supply Chain: One company’s mission to drive efficiencies and mitigate CMC development and manufacturing challenges

There are currently over 250 antibody drug conjugates (ADCs) in global clinical trials. This historically high number says more, perhaps, about drug developers’ belief in these novel, complex modalities than it does about how difficult or expensive it can be to bring them into the clinic. Challenges faced in the process of discovering, engineering, and developing ADCs start with identifying a highly specific antibody with the necessary binding affinity to the disease target, and then coupling the antibody with the most efficacious chemical payload. Added to that is the complexity of determining the correct linker biochemistry to ensure molecule serum stability and payload release, and establishing a consistent drug-to-antibody ratio.

Once the lead clinical candidate is determined, based on the preclinical screening criteria, other challenges can still make R&D efforts daunting – conducting CMC development, establishing the supply chain and manufacturing process for all three intermediates (antibody, payload and linker) as well as the bioconjugate, and devising the ideal formulation and drug-product fill process. Sourcing all of the expertise and capabilities needed to develop an ADC has typically required multiple partners, leading to extended development timelines and adding risk due to multiple project handoffs.

WuXi XDC, having a deep understanding of these special challenges, built a true single-source antibody drug conjugate CRDMO service platform that can help drug companies overcome the historic obstacles to developing ADCs. With its one-stop approach, unique expertise, critical DAR technologies, highly-vetted processes, and shortened timelines, WuXi XDC is enabling drug developers to bring these promising therapeutics more efficiently and cost effectively into the clinic and the market.