Upstream Process Design of Antibody-drug Conjugates for the Treatment of Colorectal Cancer

Abstract

: Colorectal cancer is a common tumor in the digestive tract with high morbidity and mortality. The products will continue the design of the previous group, PatritumabVedotion. The main treatment target population is HER3-positive colorectal cancer patients who are in stage 3 and stage 4. The antibody selected by our drug is patritumab, which is linked to the cytotoxic drug MMAE through a coupling reaction with MC-Val-Cit-PAB, and the average DAR of this product is expected to be 4. The target market is Europe, and combined with the actual production capacity of the factory, the annual target output is 529.7KG. In addition, two different production modes: fed-batch and Continuous is compared,and the technical and economic is analyzed.