Catalent to add two 2,000L bioreactors in $34m WI biologics plant expansion

The contract development and manufacturing organisation (CDMO) announced its Q4 fiscal year 2016 figures yesterday, and saw sales in its Drug Delivery Solutions segment of $238m (€213m), up 10% on the same period last year.

The sector includes Catalent’s biologics business, and part of the growth for the quarter was attributed to increased volumes related to its biologics blow-fill-seal offering.

And according to management, biologics services - led by its GPEx cell line platform and its SMARTag bioconjugation technology - are an increasingly important area for the firm, and one Catalent plans to “aggressively”​ grow organically.

“We continue to believe that our Biologics business is well positioned to drive future growth and comprise an increasing percentage of our overall business,”​ CFO Matt Walsh told stakeholders yesterday, citing the CDMO’s $600m conjugation deal with Roche​ earlier this year.

“At the time of the IPO [July 2014​], our dedicated Biologics business was approximately 1% of sales and that has since grown to approximately 3% of sales in FY16, so more than doubling the business over approximately three year timeframe.”​

As such, the firm said it has begun a $34m expansion at its biomanufacturing facility in Madison, Wisconsin to add two 2,000L single-use bioreactor systems in what CEO John Chiminski said would “help meet customer demand for this fast growing business.​

“The new fleet will be capable of running either 2,000L or 4,000L batches to support late-phase clinical and commercial production for our customers using single use bioreactor technology,”​ he said on the conference call.

“This expansion is an important part of our growth strategy, and builds on previous investments in our biologics capabilities.”​

Last year​, the firm completed the installation of a 1,000L bioreactor at Madison.

Softgel​

For the fiscal year 2016, Catalent reported net revenues of $1.85bn, up marginally from the year prior, while sales from the firm’s softgel technologies – its largest single product line - fell $13m to $775m.

The sector was blighted by a manufacturing suspension at Catalent’s Beinheim, France facility after out-of-place softgel capsules were discovered in several product batches during quality control procedures last November​.

Full production began in May, but the halt and investigation cost the firm approximately $50m in lost revenues, according to Jefferies analyst David Windley who said in a note the CDMO has successfully “battled through short term issues”​ and the business is showing “signs of improving stability.”​