From R&D to Clinical Supplies

Abstract

In the development of new antibody drug conjugates (ADCs), the activities performed by discovery groups typically focus on the rapid and comprehensive screening of many conjugates to find the ones with the desired efficacy and safety profiles. These conjugates are typically prepared in a combinatorial approach whereby various monoclonal antibodies (mAbs) for a specific target, linkers, and payloads are combined. These efforts usually rely on efficient screening methodologies and high-throughput tools, such as solid phase conjugation and purification arrays. The development of robust and consistent processes suitable to produce the selected candidate for clinical trials is typically not a priority for discovery. Many of the ADCs in the clinic today are based on one of two conjugation technologies and associated linker-payloads (LP). The traditional cysteine conjugation technology utilizes an auristatin as a payload with a cleavable or noncleavable linker. The other technology is based on conjugating a mayt...