Girindus has won its second process validation contract this year. The process is for the manufacture of an oligonucleotide currently in Phase III testing. It has been granted orphan drug status and the manufacturer anticipates fast-track development.
The earlier process validation contract involves a small molecule product being developed for an in vivo imaging application.
Both projects are being carried out at the Girindus America facility in Cincinnati, the city that coincidentally hosted last month's FDA/Xavier University conference on outsourcing. At the conference, the FDA discussed upcoming GMP regulation changes and recent guidance documents it's produced to encourage corporate responsibility. Process validation tops the list, followed by quality systems.
- here's the Girindus announcement
- see this article on the outsourcing conference