Establishing Commercial Manufacturing Services For Antibody-Drug Conjugates

By Jake Spies and Kerry Keith

Antibody-drug conjugates (ADCs) are complex, potent biologics that offer significant potential to address serious diseases including cancer. The clinical potential of these therapeutics is attributed to their ability to effectively target disease-associated cells while minimizing off-target toxicity. More than a dozen ADCs are currently on the market and hundreds are in development; it is estimated that the global market for ADCs could reach over 20 billion by 2030. A significant portion of ADC projects are outsourced to contract development and manufacturing organizations (CDMOs) and with the continued expansion of pipelines, this trend is likely to endure.

As more commercial products reach the market, there is an acute need for CDMOs that understand how to execute late-stage studies to support a filing strategy. CDMOs with plans to support commercial-scale ADC manufacturing are setting up processes to handle challenging supply chains and investing in facilities and processes to ensure efficiency, quality, and security.

In this white paper, we describe how our organization built upon 15+ years of experience in clinical-scale supply of ADCs, commercial-scale production of linker payloads, small molecules, and bio-organics, and an extensive knowledge base of biologics manufacturing to establish commercial-scale ADC manufacturing capabilities.