The Evolution of Antibody-Drug Manufacturing

ADCs have evolved since the initial approval of MYLOTARG® in 2000, with respect to conjugation, linker and toxin chemistries and processing. With the current availability of 4 commercially approved drugs and approximately 80 programs in various clinical trials, there has been a significant interest in simplifying the complex supply chain. With approximately 80% of the programs outsourced to Contract Development and Manufacturing Organizations (CDMOs), a transparent and integrated supply chain is critical for the success of ADC projects. This white paper will describe how chemistry and manufacturing have evolved over the past 10 years globally and how MilliporeSigma, as a CDMO, has adapted to these changes to meet customer’s needs.