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Press Release / Jun 16, 2016

Hovione announces the groundbreaking expansion plans of its New Jersey Facility

Hovione announced today that it held on June 8th the official groundbreaking for the expansion of its New Jersey facility in East Windsor, USA

New Jersey Site Expansion CDMO Continuous Manufacturing | Hovione

Loures, Portugal, June 15, 2016 – Hovione announced today that it held on June 8th the official groundbreaking for the expansion of its New Jersey facility in East Windsor, USA.

The expansion will add an additional 30,600 ft² (2,843 m²) to the existing 24,000ft² (2,211m²) facility. It will introduce a new commercial spray dryer unit to complement the existing pilot unit and this installation will be specifically designed to handle potent drug substances (APIs). In addition the Hovione New Jersey facility will more than double its capacity to manufacture drug substance. The expansion is expected to add approximately 60 new jobs to the current workforce over the next three years.

“The start of the construction activities to expand our site in East Windsor is a very exciting moment for us and for our customers. This is an important step to strengthen our continued commitment to the pharmaceutical industry and to the patients by offering innovative technologies and services. The site will be unique in offering at a single location drug substance, spray drying, hot melt extrusion and drug product manufacturing services using innovative continuous manufacturing technology. The state and especially the local government have been extremely supportive and we are happy to strengthen our presence in East Windsor by creating highly qualified jobs in the local community” said Dr. Marco Gil, General Manager, Hovione New Jersey.

“This investment is part of the company’s strategy to increase its global development and commercial capacity which will meet the increasing demands of Hovione’s customers in the API and Spray drying services. It will also include the addition of a continuous drug product manufacturing capability to its offering through the partnership with Vertex Pharmaceuticals announced earlier this year” said Kristine Senft, Vice President Marketing and Sales. 

The start-up of the operation is expected to take place in April 2017 for the drug substance and spray drying services while the continuous drug product manufacturing is planned for the end of 2017.

 

About Hovione

Hovione is an international company with over 50 years’ experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in the USA, China, Ireland, and Portugal, and development laboratories in Lisbon and New Jersey the company focuses on the most demanding customers in the most regulated markets. The company also offers branded pharmaceutical customers services for the development and compliant manufacture of innovative new drugs, and is able to support highly potent compounds. In the inhalation area Hovione is the only independent company offering a complete range of services.

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The CDMO’s New Jersey manufacturing site expansion will eventually cover more than 200,000 square feet. Portugal-based contract development and manufacturing organisation (CDMO) Hovione has completed an initial $100 million investment round in its East Windsor, New Jersey site. Once completed it will increase the facility’s footprint to more than 200,000 square feet and more than double its capacity for spray drying. Hovione CEO Jean-Luc Herbeaux said: “Since launching our New Jersey operations in 2002, Hovione has been one of the longest established European CDMOs in the United States. “This investment reinforces Hovione’s leadership in spray drying – a core technology platform where we have built extensive know-how and capabilities. By continuing to advance our platforms and expand capacity in the US, we are strengthening the foundation that enables our partners to bring complex medicines to patients more efficiently.” Spray drying is an increasingly important particle engineering technology for improving drug bioavailability through the amorphous solid dispersion (ASD) that can address bioavailability or crystallisation challenges. The initial phase of Hovione’s expansion will include a 31,000-square-foot building to house two size-3 spray dryers (PSD-3) designed for ASD production. Construction at the New Jersey site is already underway and the company plans to start GMP operations in the second quarter of 2026. The initiative is part of Hovione’s long-term strategy to grow its US operations and enhance its integrated drug substance, drug product intermediate and drug product capabilities. Herbeaux said: “This investment addresses growing customer demand for US-based capacity and integrated solutions that shorten development timelines and reduce tech transfer complexity. By consolidating development, scale-up, and commercial manufacturing within a single quality and governance framework, we provide customers with seamless execution from drug substance to drug product.” The company’s New Jersey expansion fits into its wider international growth plan that also includes capacity investments in Ireland and Portugal as it seeks to create a network of autonomous sites spanning the development and commercialisation of APIs, drug product intermediates and drug products.   Read the full article at EuropeanPharmaceuticalReview.com  

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