The pipeline for antibody–drug conjugates (ADCs) includes hundreds of candidates, with several expected to receive approval in the near future. 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 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). Explore a story of a CMO preparing for the manufacture of a commercial Antibody Drug Conjugate. Learn how to properly structure your development work, perform a thorough process risk assessment, and prepare for pre-approval inspection audit.