Thursday, October 21, 2021

CDMO Catalent tackles Warp Speed juggling act with new $50M Bloomington line, Acorda plant buyout

Catalent hustled to expand its manufacturing capacity last year as it juggled a surge of COVID-19 work with its regular production orders. That pandemic agenda caused problems in December, when the CDMO had to divert manufacturing slots for Horizon’s drug Tepezza to crank out Warp Speed vaccines. 

The laser focus on vaccines won’t abate any time soon, CEO John Chiminski said Monday at this year’s annual J.P. Morgan healthcare conference—but a new production line is now on the way, and, as of Wednesday, it has a fresh buyout on the docket.

Last month, Horizon said its thyroid eye disease med Tepezza would run scarce from the end of December into 2021, thanks to COVID-19 shot orders dominating the agenda at Catalent’s Bloomington, Indiana, facility. Operation Warp Speed had leveraged the Defense Production Act of 1950, forcing Catalent to cancel some Tepezza manufacturing slots, Horizon said. The company said it planned to increase the size of each lot of the drug Catalent produces. It’s also working to sign a second contract manufacturer.

RELATED: Catalent inks deal to offload blow-fill-seal business to SK Capital

Chiminski this week shed some light on that situation—and floated a potential timeline for when customers could expect the capacity jam to ease. 

“We’re in a certain situation in Bloomington where we do have products there that are given government-rated orders—so, they’re given priority as part of the Defense Production Act and so forth,” he said.

The problem isn’t affecting Horizon alone. “It has been a challenge for more than one customer as we juggle allocating that capacity for the rated orders versus the work that we have there,” Chiminski said. 

To compensate, Catalent has plowed $50 million into a new line at its Bloomington site, where it’s working on vaccines from Moderna and Johnson & Johnson. That line is expected to come online in April. For the “three- to four-month period” until then, Catalent will have to juggle capacity for Warp Speed orders with the work it owes its regular customers, Chiminski said. 

The “other problem,” as the CEO put it, is Catalent’s Madison, Wisconsin, facility—also subject to orders from Warp Speed. “That one will be a little bit more challenging, and we’ll probably have to work a little bit, hopefully, with OWS and our customers to kind of manage that in the interim,” Chiminski said. 

RELATED: Catalent continues big push into cell and gene therapies with Belgian facility buyout

Meanwhile, the company isn’t letting its COVID-19 work disrupt expansions into other areas. For one, the company expects to lay out “well over” half a billion dollars in new investment in 2021, largely weighted toward biologics build-outs, Chiminski said. “A notable portion” of that investment includes expansions it had already planned, he said, but will now accelerate ” to meet the elevated demand environment we’re seeing now in our biologics and cell and gene therapy offerings—in part driven by the demand related to COVID-19.”

It’s also pursuing new technologies like plasmid DNA, next-generation cell therapy, nucleic acid-based therapeutics and more, Chiminski said. 

As if to illustrate its post-pandemic ambitions, Catalent on Wednesday agreed to pony up $80 million to buy Acorda Therapeutics’ manufacturing and packaging operations in Massachusetts. The deal, expected to close in the first quarter of 2021, will see Catalent take charge of a 90,000-square-foot Acorda facility to expand spray-dried dispersion and dry powder encapsulation and packaging.

The Chelsea, Massachusetts site will complement Catalent’s 180,000 square-foot inhalation development facility in Morrisville, North Carolina, which develops and manufactures metered-dose inhalers, nasal sprays and dry powder inhalers, the company said. 

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