Hovione builds continuous manufacturing plant in U.S. for Vertex

Contract manufacturer Hovione is jumping into continuous manufacturing, building a plant in New Jersey to make products for Vertex ($VRTX). The developer of orphan drug Kalydeco and cystic fibrosis treatment Orkambi already has a continuous manufacturing facility in Boston.

Portugal-based Hovione said today that the continuous manufacturing facility will be added to a $24 million expansion at the New Jersey site that was already underway and will significantly increase the company's capacity at the site. It said it expects the project to be done by the end of next year so that it can begin manufacturing Vertex meds.

Hovione CEO Guy Villax

"Hovione and Vertex have been strong collaborators for more than a decade and share a commitment to innovative science," Guy Villax, CEO of Hovione, said in the announcement. "This agreement adds to a recently announced $24 million investment in our New Jersey facility. The entire expansion will double Hovione's development and manufacturing capacity at that site."

Hovione announced in September that it will add 30,000 square feet to the existing facility and will include a new commercial spray-dryer specifically designed to handle potent drug substances (APIs). It said the project, to be completed in early 2017, would add 60 jobs to the site.

Unlike traditional batch processing, which takes weeks to complete, continuous manufacturing feeds raw materials for solid-dose products through a nonstop process that can provide real-time release testing and produce commercial-ready tablets in a day. Hovione said that continuous manufacturing is well suited for drugs that have received breakthrough therapy designations where development timelines are short.

The contract manufacturer said the new facility will incorporate all facets of the continuous manufacturing process, including continuous blending, wet or dry granulation, fluid bed drying, tableting and coating operations. Any capacity not needed for Vertex drugs will be offered to other clients, Hovione explained.

"This agreement enables Hovione to be at the forefront of an important evolution toward the use of continuous manufacturing and positions us as a reliable and innovative source for the production of new medicines," Filipe Gaspar, VP of R&D at Hovione, said in the announcement. "Like Vertex, we view continuous manufacturing as an important scientific advance and an important advance for patients, as the technology will allow us to run manufacturing and process development in parallel with clinical studies to more rapidly bring new medicines to those who need them."

Vertex invested $30 million in a 4,000-square-foot continuous manufacturing facility in Boston in anticipation that it will get approval for its new cystic fibrosis drug, Orkambi, which was approved by the FDA last July. A number of drugmakers have been incorporating continuous manufacturing operations into the networks, drawn by the fact that the plants are much smaller and so cost less to erect and operate. Vertex, and now Hovione, join GlaxoSmithKline ($GSK), Novartis ($NVS), Johnson & Johnson ($JNJ) and others that are moving the industry out of its decades-old processes into a new realm in which some drugs can be manufactured without using the time-consuming, chemical heavy batch processes.

- here's the announcement