New Jersey, USA

Hovione in USA

Hovione LLC
Technology Transfer Center

40 Lake Drive
East Windsor, NJ 08520
USA

Tel: +1 609 918 2600
Fax: +1 609 918 2615

e-mail:

Click here to access:
- Directions to reach the TTC
- Floor Plan
- "2004 Lab of the Year Award"

Hovione’s new 3,000m2 Technology Transfer Centre (TTC) in East Windsor, New Jersey, USA, initiated operations in September 2002. The site serves as Headquarters for Hovione’s US Operations, and consist of process chemistry R&D labs, cGMP kilo and scale-up labs and a cGMP pilot plant. The TTC is also the home of Hovione’s commercial offices and provides for cGMP storage and repackaging of finished goods. The TTC offers Hovione´s US based customers process development and scale-up services, along with quality control/assurance and regulatory support. The cGMP facility is designed to prepare small quantity NCE’s to support customer's pre-clinical and early-phase clinical development, demonstrating the customer’s processes locally before transferring them to Hovione's full scale manufacturing plants, in Europe and Asia.
In 2007 the site was first approved by the FDA and received the VPP Star Award  by the Occupational Safety and Health Administration (OSHA).

Two successful technology transfers were successfully carried out from New Jersey to Portugal and Macau during the past 3 years.

The technical capability of the TTC mimics that of Hovione's fully commercial facilities for seamless transition to commercial scale production. The TTC is fully integrated into Hovione's global quality network offering US customers real-time data and regulatory support for on-going production in the manufacturing plants. Operating under the same procedures, company culture, and team management, the New Jersey located TTC will benefit customers with efficient, seamless and cost-effective technology transfer.

The development labs, staffed with multi-disciplinary project teams, allow fast turn around in producing small quantity pre-clinical APIs and investigates emerging technologies for scale-up for incorporation into Hovione's core capabilities. Process R&D and scale-up studies, carried out in glassware to 22 lt, will help to identify potential problems for eventual industrialization of the synthetic process.

The Kilo Lab has a capacity to 200 lt in glass-lined reactors and 100 lt Hastelloy® C-22 cryogenic reactors. The kilo lab continues to develop the process and produces pre-approval quantities for clinical studies in compliance with strict cGMP procedures.

The Pilot Plant, equipped with a 400 lt Hastelloy® C-22 cryogenic reactor and 800 lt glass-lined vessels, produces kilo quantities of API under cGMP. From the pilot plant, a seamless technology transfer of industrial scale quantities is in place for full-scale commercialization.

The Finished Goods storage allows for local stocking in compliance with cGMP of all Hovione API's for US customers.

Sales, Marketing and Administrative offices communicating via a global IT connection provide a permanent presence and service to US customers, a market that already represents over 60% of Hovione Group sales.

Headed by Dave Hoffman, the TTC is located on an 8 acre parcel of land just off exit 8 of the New Jersey Turnpike, and is ideally located close to nine of the world's major pharmaceutical companies. The TTC employs 33 people and has an expansion capability up to 45.

This USD18M investment demonstrates the Company's commitment to constant but secure expansion in the business of APIs, addressing a growth strategy directed at strengthening Hovione´s leading position in servicing the Pharma Industry.

The TTC was approved as a VPP (Voluntary Protection Program) Star participant of the US Department of Labour which recognizes sustained excellence in all areas of safety and health management.

• click here for FAQs (General and TTC)
• click here for the TTC Brochure (pdf file)