News

Posted On: 09/20/2007

GSK Specifies RMM in its Veramyst New Drug Application

PharmaManufacturing.com

GlaxoSmithKline’s New Drug Application (NDA) for Veramyst nasal spray is the first FDA-approved 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 reductions in operational costs, manufacturing cycle times and overall risk by identifying product contamination earlier in the manufacturing process, according to the company.

Early detection of product contamination minimizes the potential financial loss and allows for more effective corrective action by limiting 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.