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:
-
Speech by Guy Villax, on the occasion of the presentation of VPP Star plaque and flag
- 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, a cGMP pilot plant
and a cGMP Mobile Minor Spray Dryer. 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 2005 the
TTC increased its technologies portfolio to handle highly potent compounds.
In 2007 the site was first approved by the FDA and received the VPP Star
Award by the Occupational Safety and Health Administration (OSHA).
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.
• click
here for FAQs (General and TTC)
• click
here for the TTC Brochure (pdf file)
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