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. Nine ADCs are currently on the market and hundreds are in development. It is estimated that the global market for ADCs could reach nearly $10 billion by 2025.

A significant portion of ADC projects are outsourced to contract development and manufacturing organizations (CDMOs) and with 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.

Listen to our webinar to learn how our organization built upon 12+ 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. Our experience with ADCs includes more than 65 unique development projects and more than 600 development batches spanning many ADC technologies from conventional, to bispecific and antibody fragments, as well as a range of cleavable and non-cleavable linkers and many types of cytotoxic payloads. In 2015, we opened our commercial facility and since that time, have produced more than 160 GMP batches which included more than 20 commercial batches. These batches have enabled more than 30 investigational new drugs (INDs).

Our journey to commercialization started with determining what was required and expected for commercial ADC manufacturing including control strategies, risk assessment, process characterization and validation. Our extensive preparation lead to getting the approval to manufacture commercial batches.

Join our webinar to learn how to properly structure your development work, perform a thorough process risk assessment and prepare for pre-approval inspection.