Catalent has announced the launch of an accelerated gene-to-drug substance programme for complex biologics in the US, promising to help developers move next-generation molecules from gene sequence to drug substance in ten months.
The CDMO already has a Rapid Antibody offering designed to move traditional mAbs from gene sequence to GMP drug substance in just eight months, which was announced earlier this year.
The new programme expands on this framework, using the company's core proprietary GPEx Lightning cell line and tailoring it for complex biologics.
"For patients facing serious conditions, faster access to advanced biologics can be critical," said David McErlane, Biologics Group President for Catalent.
With GPEx Lightning and our integrated US 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.
With biologic pipelines shifting towards more varied and complex formats, Catalent said that its new programme will give developers a predictable path from early development to clinical supply, combining the company's GPEx Lightning cell line development tech with integrated development and manufacturing workflows to "bring complex biologics closer to the speed traditionally associated with standard mAbs."
The CDMO added that the complex biologics timeline would include the following three customer-facing milestones from gene sequence:
- Master cell bank conditional release anticipated by month seven
- Bulk drug substance shipment to Catalent’s drug product site anticipated by month nine
- Bulk drug substance lot release anticipated by month ten.
The launch follows a successful debt refinancing in August, when the company completed a significant debt refinancing transaction to "support continued growth" while reducing borrowing costs.
