CDMO Catalent is considering adding two more manufacturing trains at its Madison facility due to anticipated demand for sub-5,000 L biomanufacturing.

For Catalent’s fourth quarter FY2018, sales from its Biologics and Specialty Drug Delivery business stood at US$196 million (€168 million), twice that of the same period last year.

The contract development and manufacturing organization (CDMO) attributed much of this increase to the acquisition of Cook Pharmica and the addition of a biomanufacturing facility in Bloomington, Indiana. However, management told investors some of the revenue jump came from a third biomanufacturing train at its Madison, Wisconsin plant which began operations in the quarter.

“We’ve already signed a number of customer contracts for the third train while also growing a robust funnel of late-stage clinical opportunities, which together will help increase the utilization of the new capacity in fiscal year 2019 to more than 50%,” CEO John Chiminski said on a conference call (transcript here).

The expansion has provided the facility with an additional 22,000 square feet of space and consists of two 2,000 L single-use bioreactor systems to support late-phase clinical and commercial production of up to 4,000 L batches.

Fourth and fifth line

And Chiminski added on the call the firm is now beginning to look at adding a fourth and a fifth biomanufacturing train at the site.

Mike Riley, VP and general manager of Drug Substance and Bioanalytical services for Catalent Biologics, told BioProcess Insider that continued investment in biologics capabilities is a direct response to strong market demand, particularly for products requiring flexible capacity at less than 5,000 L bioreactor scale.

“This additional expansion will add increased flexibility to current and new customers as they look to Catalent to support their late phase and commercial production needs. With the addition of the additional drug substance and biologics fill/finish capabilities at our newly acquired Bloomington, Indiana facility, we are well positioned to provide an integrated solution from drug substance to finished dose form.”

Financial costs and gains

Riley did not disclose the likely investment required at this stage, nor the size of the potential revenue it would generate.

But on the call, management spoke of the potential of the complete and operating third train.

“This site is running at about $75 million and we have the ability to nearly double it with the third train that’s coming on,” VP of finance and Investor Relations Thomas Castellano said. “We’ve not given any financial disclosure on what fourth and fifth train could mean for the future revenue on this facility.”