Press Room

Press Release / May 20, 1996

Contrast Media and Custom Services are two key areas in Hovione's strategic analysis document

Contrast Media is one of two important areas that Hovione defined as key in its 1994 I&DEIA XXI strategic analysis document, the other being offering custom services to the US majors.

Hovione is a technology rich company excelling in both difficult chemistry as well as GMP and regulatory affairs.

By always tackling the products that others were not interested in because of their difficulty and always taking a pro-active attitude to meeting (instead of avoiding) FDA's increasing severity and tough standards, Hovione is now well equipped to serve the outsourcing needs of the largest US pharmaceuticals companies.

Contrast media is an area where no independent manufacturer of bulk existed, the first products to come off patent did so less than 12 months ago, so it was an obvious area where Hovione's skills could be turned into dollars. The surprise was how technically difficult this really was. A team of 60 researchers at Hovione worked non-stop for three years.

Contrast media is an area of very high barriers to entry: one needs large capacity (to be a player you need a capacity well in excess of 50 tonnes/year), great technical competence (to meet purity levels of 99.8% and near sterile quality of tonne size batches), know-how and the industrial scale technology to recycle tens of thousands of tonnes of solvents, and last but certainly not least you need to have the ability to prepare tens of kilos of paper meeting every one of FDA's requirements.

These products are in many occasions injected, in a single dose, in quantities of 150g. This is the largest parenteral administration of a chemical to a human. Clearly an area only for the most competent and quality generic firms, the market perceives Hovione as such a company.

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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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