Somerset, New Jersey-based CDMO Catalent says it has racked up 20 drug approvals for the Indiana biologics plant it picked up in its $950 million deal for Cook Pharmica last year. With that, Catalent says it needs to expand the facility and add workers.
Catalent Pharma Solutions will invest nearly $14 million to expand biologics packaging capabilities and capacity at the Bloomington, Indiana, biologics manufacturing facility. It expects to add 36 jobs as a result.
It is building a 15,000-square-foot facility infrastructure that it says will include five packaging suites and a quality control laboratory. The company expects to have all of that complete in February of next year but will phase the installation and commissioning of new equipment throughout the year.
Catalent acquired the 875,000-square-foot biologics development and manufacturing facility in 2017 when it agreed to pay $750 million to privately held Cook Group on closing and the rest in $50 million installments over the next four years. The Cook CDMO business had revenues of $179 million in 2016, the year before Catalent acquired it.
When it got the Indiana plant, CFO Matt Walsh said the facility was running only about 40% capacity, leaving lots of room for organic growth. He said about half of the plant’s footprint was available for expansion, which the company saw as a benefit of the deal, allowing it to grow “without substantial investment in the near term.”
But the acquisition has had its challenges. In May the FDA issued the plant a Form 483, after inspectors found “an unacceptably high number of mold recoveries in the classified rooms used for the manufacture” of bulk drugs. The agency said the number of mold recoveries has been “trending” higher since 2015. Catalent said it had “self-identified” most of the items in the observations and a corrective and preventive action plan (CAPA) was in place before the preapproval inspection.