Press Room

Press Release / Mar 03, 2001

Hovione locates US Operations in East Windsor Township

East Windsor Township - Princeton, 2nd March, 2001 – Mayor Janice S. Mironov, East Windsor Township, East Windsor, New Jersey and David Hoffman, President, US Operations, Hovione LLC, Princeton, New Jersey, a wholly owned subsidiary of Hovione SA, are pleased to announce East Windsor Township will be the site of Hovione’s Technology Transfer Center (TTC). The TTC will be located on an 8 acre parcel of land just off exit 8 of the New Jersey Turnpike. The site will consist of commercial offices as well as scale-up and development laboratories. Initial occupancy is scheduled for the 1st Quarter 2001 and will provide employment for 26 people with an expansion capability up to 45. According to Mr. Hoffman, East Windsor Township is an ideal location for technology companies servicing the Pharmaceutical Industry due to the township’s proximity to 9 of the world´s major pharmaceutical companies. The township also has an excellent professional community owing to its centralized location between New York and Philadelphia.

According to Mayor Janice S. Mironov, “We are pleased to welcome the US corporate  of an international pharmaceutical active ingredients company such as Hovione to our community. Hovione is an exciting addition to the many firms which have recently located corporate offices and facilities in East Windsor Township, whose superior location and great accessibility were important considerations for these firms”.

Hovione will offer process development and scale up services, along with quality control/assurance and regulatory support to the pharmaceutical industry. The technical capability of the TTC will mimic that of Hovione’s fully commercial facilities located in Europe and South China for seamless transition to commercial scale production. The TTC will be fully integrated into Hovione’s global quality network offering US customers real-time data and regulatory support for on-going production in Europe and China.

CUH2A, Inc. (Princeton, NJ) has been appointed as the architectural engineering firm and Engineered Technologies Corporation, (Providence, RI) the equipment manufacturer for the TTC. Bids are currently under consideration for the construction and build-out of the facility.

Hovione is a global manufacturing company committed to the Pharmaceutical Industry. The principle area of focus is providing specialized technical skills to solve complex problems associated with the development and manufacture of the key active ingredients used in medicines.

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Continuous Tableting (CT) is defined as continuous manufacturing of oral dose drugs, specifically tablets. As per ICH's Q13 definition1, a continuous manufacturing process in the pharmaceutical industry comprises at least two unit operations integrated from a mechanical and software perspective. There is a wide combination of possible CT process configurations that are dependent on the needs of the intended product formulation and each of the individual unit operations that constitute the process train can be continuous, semi-continuous, or batch processes. The typical manufacturing processes for tablet formulation are direct compression (DC), dry granulation (DG) and wet granulation (WG)2 - details on these manufacturing processes are beyond the scope of this article, so the interested reader is directed to relevant literature. The actual implementation of CT technology in a facility can broadly vary depending on the level of desired integration and automation. Process trains can be designed to be flexible and converted between multiple configurations (e.g. continuous DC, DG and WG), controlled by the end user from one single software and within a single clean room. The other possibility would be for subsections of the CT process to be divided into multiple clean rooms where inprocess materials are transferred between suites via a bin-to-bin approach (e.g. a granulation suite to prepare granules from raw materials followed by continuous DC (CDC) to blend the granules and produce tablets). The level of automation and instrumentation designed into the CT process (typically involving Process Analytical Technologies, PAT) can open the possibility to implement sophisticated control strategies. Key components of a control strategy that need to be considered for CT are material tracking and genealogy, knowledge of the residence time distribution (RTD), and in-process controls (spectroscopic and/or soft sensors based on process parameters). Holistically, these control strategy elements enable the implementation of a material diversion strategy to automatically divert out of specification material from the process. In their most advanced form, control strategies may also enable real time release testing (RTRt) of the final tablet drug product and reduce the off-line analytical burden and the number of operators needed to manage the process.   Read the full article at gmp-journal.com  

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