Catalent Launches Accelerated Gene-to-Drug Substance Program in US for Complex Biologics

Editor’s Take: As biologic pipelines shift toward more complex formats, accelerated programs can give developers a more predictable path forward.

Catalent is launching an accelerated gene-to-drug substance program in the United States for complex molecules, namely biologics. The company says the offering complements its drug substance and drug product capabilities.

The program helps developers move bispecifics, multispecifics, and other next-generation molecules from gene sequence to drug substance in 10 months. This includes later steps in the path including from bulk drug substance to fill-finish readiness.

Biologics Building Blocks

Catalent says this builds on its Rapid Antibody offering, for traditional monoclonal antibodies (mAbs). This supports gene-to-GMP (good manufacturing practice) drug substance in as few as eight months.

“For patients facing serious conditions, faster access to advanced biologics can be critical.”

David McErlane, Catalent Biologics Group President

According to Catalent, biologic pipelines are shifting toward more complex formats. That being the case, accelerated programs can give developers a more predictable path from early development to clinical supply.

Catalent’s program combines its GPEx Lightning cell line development technology with integrated development and manufacturing workflows. Adding in U.S.-based execution, Catalent says it can bring complex biologics along at a speed usually associated with standard mAbs.

Outline of Catalent Process Milestones

Specifically, Catalent’s timeline for complex biologics involves three customer-facing milestones from gene sequence. Master cell bank conditional release is anticipated by month seven. Following this—bulk drug substance shipments to Catalent by month nine, and bulk drug substance lot release by month 10.

“For patients facing serious conditions, faster access to advanced biologics can be critical,” Catalent Biologics Group President David McErlane said. “Catalent is helping customers move complex antibodies through a defined, disciplined path to the clinic.”

A global CDMO, Catalent employs thousands of scientists and technicians at nearly 40 sites worldwide.