Five successful technology transfers were successfully carried out from New Jersey to Portugal and Macau during the past 5 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 260 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 Mobile Minor Spray Dryer allow to process DOE, scale up and manufacture under cGMP with greater flexibility in controlling and optimizing the particle attributes of pre-formulated APIs.

The facility is equipped with 3 ISO 8 packing rooms along with different drying technologies (Tray Dryer, Filter Dryer and Freeze Dryer).

The manufacturing areas at the TTC can handle products highly potent APIs with an Occupational exposure limit of 0.5 µg/m3 TWA 8 hr.

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.

The TTC has been approved by the FDA for commercial manufacture through a successful PAI with no 483.

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