Lyophilization Services of New England (LSNE), a contract development and manufacturing organization (CDMO), continues its ongoing expansion at its Bedford, New Hampshire site, adding increased short- and long-term current good manufacturing practice (cGMP) storage capabilities. The expanded facility meets the requirements of controlled room temperature, refrigerated, and frozen temperature-sensitive products.
Additionally, the growth project has added ICH stability chambers for standard storage conditions including -20°C, 2-8°C, 25°C/60%RH, 30°C/65%RH, 40°C/75%RH.
Jeff Clement, VP of business development at LSNE, told Outsourcing-Pharma, “More and more of our clients told us that they sometimes struggle finding long term validated storage options. Our capacity was limited, so this increase in validated storage space it already working out very well for our existing clients.”
The Bedford site also houses LSNE’s quality control laboratory for analytical and microbiology testing services. With the addition of the cGMP storage capabilities at the site, LSNE said it will be able to provide a solution to address its clients’ cold chain storage requirements.
Shawn Cain, COO at LSNE, said, “Having 80,000 cubic feet of additional on-site cGMP temperature-controlled storage will ensure products reaching patients around the world are stored properly. We understand dependable storage is critical to our clients' products.”
Aside from its four New Hampshire facilities, LSNE has sites in Wisconsin and Spain.