- Catalent has launched a U.S. gene-to-drug substance program designed to move bispecifics, multispecifics and other complex biologics from gene sequence to drug substance in 10 months.
- The program combines GPEx® Lightning cell line development technology with integrated development and manufacturing workflows and U.S.-based execution.
Catalent, a global contract development and manufacturing organization (CDMO), has launched a U.S. accelerated gene-to-drug substance program for complex biologics. The program is designed to move bispecifics, multispecifics and other next-generation molecules from gene sequence to drug substance in 10 months. It builds on Catalent’s Rapid Antibody offering for traditional monoclonal antibodies (mAbs), which supports gene-to-GMP drug substance in as little as eight months.
The program combines GPEx® Lightning cell line development technology with integrated development and manufacturing workflows. Catalent said the approach is intended to provide developers with a predictable path from early development to clinical supply as biologic pipelines shift toward more complex formats.
The timeline includes three customer-facing milestones. Conditional release of the master cell bank is anticipated by month seven, bulk drug substance shipment to Catalent’s drug product site by month nine, and bulk drug substance lot release by month 10.
The accelerated complex biologics offering provides a 10-month timeline for multichain complex molecules alongside Catalent’s targeted eight-month gene-to-GMP drug substance timeline for traditional mAbs. The company said the offering complements its drug substance and drug product capabilities, providing an integrated route from gene sequence through bulk drug substance and into fill-finish readiness.
“With GPEx® Lightning and our integrated U.S. development and manufacturing network, Catalent is helping customers move complex antibodies through a defined, disciplined path to the clinic while preserving the speed expected of our Rapid Antibody program for traditional mAbs.”
David McErlane, Biologics Group President at Catalent
