How Optimizing Process Parameters Can Improve Scalability and Manufacturability of a Cytotoxic Antibody Drug Conjugate

Antibody-drug conjugates (ADCs) are a growing drug class consisting of a monoclonal antibody (mAb) attached to a cytotoxic drug via a linker. In 2021, eleven US Food and Drug Administration (FDA) approved ADCs were available [1] to treat a range of blood and solid tumor-based cancers, and more than 80 were in active clinical trials [2]. A recent report estimates that the worldwide market for ADCs could reach $ 23.9 billion by 2028 and could grow annually at 23.7% [3]. However, market growth is dependent on being able to efficiently manufacture ADCs to produce sufficient commercial scale supply at the cost of goods which ensures these drugs will be widely available, as well as affordable.