Catalent Launches Accelerated Gene-to-Drug Substance Program for Complex Molecules in the U.S.

• New offering brings next-generation biologics timelines in line with those for monoclonal antibodies (mAbs).
• U.S.-based offering delivers bispecifics, multispecifics and other complex biologics from gene to drug substance in 10 months, accelerating timelines for next-generation therapies.

Catalent, Inc., the leading global contract development and manufacturing organization (CDMO) dedicated to helping people live better and healthier lives, today announced the U.S. launch of an accelerated gene-to-drug substance program for complex biologics, designed to help developers move bispecifics, multispecifics and other next-generation molecules from gene sequence to drug substance in 10 months. The program builds on Catalent's Rapid Antibody offering for traditional mAbs, which supports gene-to-GMP drug substance in as little as 8 months.

"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 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."

With biologic pipelines shifting toward more complex formats, this accelerated program provides developers with a predictable path from early development to clinical supply. The program combines GPEx^® Lightning cell line development technology, integrated development and manufacturing workflows, and U.S.-based execution to bring complex biologics closer to the speed traditionally associated with standard mAbs.

The complex biologics timeline includes three customer-facing milestones from gene sequence:

• Master cell bank conditional release anticipated by month 7.
• Bulk drug substance shipment to Catalent’s drug product site anticipated by month 9.
• Bulk drug substance lot release anticipated by month 10.

Together, Catalent’s accelerated development offerings provide customers with two clear paths: a targeted 8-month gene-to-GMP drug substance timeline for traditional mAbs and a 10-month timeline for multichain complex molecules. The offering complements Catalent's drug substance and drug product capabilities, giving developers an integrated route from gene sequence through bulk drug substance and into fill-finish readiness.

About Catalent

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) championing the missions that help people live better and healthier lives. Every product that Catalent helps develop, manufacture and launch reflects its commitment to improve health outcomes around the world through its Patient First approach. Catalent provides unparalleled service to pharma, biotech and consumer health customers, delivering on their missions to transform lives. Catalent tailors end-to-end solutions to meet customers’ needs in all phases of development and manufacturing. With thousands of scientists and technicians and the latest technology platforms at nearly 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. For more information, visit www.catalent.com.

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"For patients facing serious conditions, faster access to advanced biologics can be critical," said David McErlane, Biologics Group President for Catalent.