Biopharma-Reporter caught up with Catalent’s Vice President of Global Operations Steve Leonard at CPhI Worldwide in Madrid yesterday, who said the contract development and manufacturing organisation (CDMO) is ready to expand its biomanufacturing site in Madison, Wisconsin in order to keep up with strong demand for services.
“We’re contemplating the next round of investment, as the significant investment made out there a couple of years ago is really almost full already - which is a great problem to have,” he told us.
“When we built the facility, we built enough footprint to house additional suites inside and so we’ve facilitated a couple of the equipment trains and suites, and we’re now starting to look at the next round of investment to fund some more scale capacity.”
Early-phase projects and single-use
While Leonard said an expansion would further increase commercial capabilities – the firm has recently implemented a 1,000L single-use bioreactor – much of the space is dedicated to early-phase projects, driven by demand from biotech and start-ups looking to speedily move their molecule through the development process.
“In the biologics space, the majority of our business and our new clients is coming from the SME sector,” he said. “We deal with a lot of early phase startups that are moving from one venture capital funding tranche to the next.
“Our job is to help them as quickly as we can to get to the proof of concept and reach the next milestone so they can get there next tranche of funding.”
This is why the facility is fully single-use, he continued, as the speed associated with disposable equipment is the most important factor for such customers.
“They have a tranche of funding and they’re on the clock, so everyday matters and if we’re taking time to turn around, cleaning validation and all the risks that come with that they just can’t tolerate that.”
Big Pharma
A common strategy for biotechs and start-ups is to sell their molecules to larger players once they have proved successful in the early-stages, and Leonard said Catalent is keen to continue “to have a relationship with that molecule as it changes hand.”
But Big Biopharma firms often have their own manufacturing networks which “their first priority is to fill up,” and therefore Leonard said Catalent has on occasion seen some products that it made in clinical batches move to Big Pharma.
“Where they have the capability, their first tendency is to make it themselves, and who can blame them?”
However, he added such firms are still major customers for Catalent, “they’ll continue to outsource for reasons of cost, reasons of capacity and reasons of specialist technologies, and the latter of these has always been our sweet-spot.”