Rapid Microbial Monitoring Supports FDA Approval of GSK’s NDA

PharmaManufacturing.com
08/07/2007

Celsis International plc on Aug. 6 announced that GlaxoSmithKline's New Drug Application (NDA) for Veramyst nasal spray is the first approval of an NDA that references Celsis' Rapid Microbiological Method (RMM) as part of a regulatory submission. GlaxoSmithKline uses Celsis' Rapid Detection systems, an alternative testing method based on ATP bioluminescence technology, to screen products for microbiological contamination.

FDA's approval of Veramyst builds on acceptance of the Celsis Rapid Detection System as a microbiological in-process and end-product release testing method for pharmaceutical and biopharmaceutical products by other regulatory agencies around the world.

Celsis' Rapid Detection system provides economic value through reduced operational costs, manufacturing cycle times and overall risk by identification of product contamination earlier in the manufacturing process, according to the company. Early detection of product contamination reduces the potential financial loss and allows for more effective corrective action by reducing the volume of contaminated product.

Celsis was the first company whose rapid microbiological detection product was granted regulatory approval as part of a product license in 1997. Today numerous companies, including the top 10 global pharmaceutical companies, have received regulatory approval for the use of Rapid Detection in their quality control testing. Further information can be found on the company's website at www.celsis.com.