Thermo Fisher Continues To Expand Sterile Injectables Development Capabilities In Monza, Italy
The sterile injectables market continues to grow quickly, driven in large part by the increase of biologic therapies in development. Recognizing the continued strong demand for sterile injectable development services, Thermo Fisher’s Pharma Services announced the $25 million investment in its Monza, Italy site to establish state-of-the-art development capabilities, including:
- Isolator technology and automatic lyophilization loading / unloading to meet current regulatory and quality expectations for compliance
- 100% in-line weight checking to eliminate destructive testing and reduce filling-weight rejections to increase yields
- A very broad range of batch sizes and vial sizes to provide flexible options for clients
The project is proceeding rapidly and the construction of the exterior of the 2,300 m2 facility is nearing completion. Equipment is beginning to arrive on site and the new facility is expected to be fully operational in the second half of 2019.
Pharma Services is a leader in sterile injectables development and commercial manufacturing, with 14 NDAs and leads all other CDMOs in NDAs. More information on the company’s steriles capabilities can be found here.