Aptuit scales up its production prowess for Phase III trials

Contract drug developer Aptuit has bolstered its in-house production capabilities and can now churn out doses for Phase III trials, a move the company says was motivated by client demand.

Aptuit has long had the ability to manufacture active ingredients at a scale appropriate for early- and mid-stage clinical trials, providing sponsors with formulation development and analytical services in the process. But, because the company's offering topped out at Phase II-scale production, its clients had to switch contractors in the run-up to pivotal trials, which can be a daunting proposition.

Now the Greenwich, CT, outfit has dialed up its capacity, bringing in the necessary equipment and manufacturing technology to support global Phase III trials and commercial production. Aptuit plans to handle such large-scale work at its facilities in Verona, Italy, and Oxford, U.K.

"Our company is experiencing significantly increased demand due to outstanding scientific excellence and unique ability to fully integrate CMC," Aptuit CEO Jonathan Goldman said in a statement. "We are delighted to respond with a high-quality solution by expanding capacity and capability."

The move follows an April expansion of Aptuit's Oxford facility, in which the company added formulation technology to support what it said was a three-fold increase in demand for preclinical development services.

In January, Aptuit sold off a pair of sites to AMRI ($AMRI) for $60 million, backing away from clinical manufacturing and solid-state chemistry to better focus on its work in discovery and development.

- read the statement

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