Niro extends drying test centre for pharma - Lyophilization Articles & Reports

Niro extends drying test centre for pharma
02/03/2005
NOVIS
Denmark-headquartered Niro is finalizing a ?10 million investment programme centred on the expansion of its drying test site, located at its main facility in Copenhagen, that will extend its reach into the pharmaceutical sector, reports Phil Taylor.
The latest round of investment will also make the centre the largest of its type in the world, with more than 35 pilot plants available for use by its customers, according to Niro.
The test centre already has an extensive range of equipment and pilot plants for process and product evaluation including spray dryers, freeze dryers, extractors, agglomerators and analytical laboratory facilities, and has been providing services to the food and other industries since the 1960s, including some non-Good Manufacturing Practice product development projects for pharma companies.
But the ltest installation of a full GMP spray drying line means that customers can now use the facilities to make clinical trial materials on fully-validated equipment, at the same scale as may be required for full production, said a Niro spokesman. The company estimates that this could carve a year off development times, which could pay dividends by extending the period the drug is patent-protected in the marketplace. One year?s extension can be significant, given that some projects lose as much as 80 per cent of their sales from generic competition in the first year.
Very few companies are offering this type of service, said the spokesman, and the hope is that the test centre will drive Niro?s sales as companies purchase machines to handle commercial production of successful clinical projects. Niro is the world?s largest supplier of spray drying equipment.
The new spray drying line has already been approved by the Danish Medicines Agency for producing clinical trial materials, and includes several pharmaceutical process options to provide a wide range of spray-drying technology for product development, realistic testing and scale-up to production size. The centre can evaluate spray-drying processes using both aqueous and organic solvent feeds, according to Niro.