Rapid Antibody Gene-To-Drug Substance

For innovators developing traditional monoclonal antibodies, Catalent offers a proven gene-to-drug substance platform built to achieve a pivotal milestone: the reliable delivery of GMP-grade drug substance to support IND submissions and first-in-human clinical studies.

Through a fully integrated and streamlined approach, Catalent enables faster progression from gene sequence to clinical-ready material while maintaining strong process control, scalability, and regulatory alignment. This ensures that programs are not only accelerated but also positioned for seamless transition into later-stage development and clinical supply, with manufacturing readiness established from the outset.