Hovione has opened the doors to its new 31,000 sq ft facility in East Windsor, New Jersey, completing its $100m investment in its US operations.
The CDMO said the site — named 89 Twin Rivers — has added two GMP-ready, commercial-scale PSD-3 spray dryers to its manufacturing capabilities, doubling the company's US spray drying capacity.
The new facility will operate under the campus´s existing FDA registration.
Hovione said in its announcement that the New Jersey site would strengthen its integrated pathway from formulation screening to commercial manufacturing of spray-dried amorphous solid dispersions — which, crucially, is all under one quality system, reducing technology transfer and providing greater manufacturing continuity.
The site is aiming to address the solubility and bioavailability issues that plague around 70% of small-molecule drug candidates and slow development.
Hovione said it addresses these persistent formulation challenges by turning the poorly soluble drug ingredients into more bioavailable forms using amorphous solid dispersions through its specialised spray drying platform.
“Opening 89 Twin Rivers is more than a capacity expansion," said Marco Gil and Antonio Almeida, co-CEOs of Hovione. "It marks the next chapter in Hovione’s legacy of more than two decades in the US.”
This investment enables us to meet growing demand while further reinforcing our global leadership in pharmaceutical spray drying.
"Equally important, this technology sits within an integrated offering that extends from drug substance through drug product, giving customers a more direct and resilient path from early development to commercial."
"This is how we help them address poor solubility, one of the industry’s most persistent development challenges and bring complex medicines to patients faster.”
Hovione added that its vision for the coming decade is to continue growing its US operations, with the East Windsor campus continuing to expand during the next five to ten years and plans to develop approximately an adjacent property into a 125,000 sq ft manufacturing facility supporting additional laboratories, commercial-scale spray drying and oral drug product manufacturing.
The company added that customers could co-invest in this planned expansion to gain priority access to proprietary Hovione platforms, engineering know-how and accelerated capital deployment to speed up their programmes.
"89 Twin Rivers is a major step forward for Hovione’s US operations and a clear expression of our long-term commitment to East Windsor and New Jersey,” said David Basile, Vice President of Technical Operations, Americas, at Hovione.
“Our growth has been built on sustained investment in scientific expertise, technological innovation, advanced manufacturing capabilities and talented people."
As we look to the future, we will continue to strengthen this site as an innovation hub for pharmaceutical development and manufacturing, contributing to the competitiveness of New Jersey’s life sciences ecosystem and to a stronger US manufacturing base.
The site opening follows recent news that the company had appointed Stefan Doboczky as CEO, who will take up the post in April next year.
Hovione has also recently completed the expansion of its tablet development and manufacturing centre at its main global campus in Portugal, expanding its batch tabletting capacity.
