Engineers Journal, December 5, 2017
Hovione is pleased to announce that its new and latest facility, the Technology Transfer Centre (TTC) located in East Windsor, NJ, is now open and in full operation. The 30.000 sq.feet / 3000m2. state-of-the-art facility consists of process chemistry R&D labs and scale-up facilities to springboard pharmaceutical pipeline products into full commercialization.
Headed by Dave Hoffman, the TTC is ideally located just off exit 8 of the New Jersey Turnpike, in close proximity to nine of the world’s major pharmaceutical companies. A Greenfield project, the site now employs 16 people with the capability of expanding up to 45. The TTC offers Hovione’s US based customers process development and scale up services, along with quality control/assurance and regulatory support. The cGMP kilo-lab and pilot plant, aimed at preparing small quantity NCE’s to support customer’s pre-clinical and early phase clinical development, demonstrate processes locally before transferring them to Hovione’s full scale manufacturing plants, in Europe and Asia.
- The development labs, staffed with multi-disciplinary project teams, allow fast turn around in producing small quantity pre-clinical APIs and investigate 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, aim to identify potential problems arising with the 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 develops the industrialization of the process and produce 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 guarantee local stocking in compliance with cGMP of all Hovione APIs 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.
The technical capacity of the TTC mimics that of Hovione’s fully commercial quantities 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 ongoing production in the manufacturing plants. Operating under the same procedures, company culture and team management, TTC benefits customers with efficient, seamless and cost-effective technology transfer.
“The unique design and equipment of our TTC compliments Hovione’s existing facilities in Europe and Asia and allow us to expand upon our core capabilities,” says Dave Hoffman. “Those of us with Hovione in the US are proud to carry on the tradition of excellence in service to the pharmaceutical industry, first established by Ivan Villax over 40 years ago.”
Hovione is an independent, privately held, European-based producer of Active Pharmaceutical Ingredients. Hovione is dedicated to the process development, quality and synthesis of APIs, serving exclusively the Pharma industry, Hovione is a specialist in manufacturing difficult to make APIs and Regulated Intermediates under the most stringent controls of safety, quality and environmental protection. Hovione has more than 40 years of experience in chemical processes and, with 500 m3 of reactor capacity, has produced industrially more than 40 APIs.