Adds increased validated storage to support clients' long-term needs
Bedford, NH /PRNewswire/ - Lyophilization Services of New England (LSNE), a leading contract development and manufacturing organization, continues their expansion with the addition of increased cGMP storage capabilities at its 7 Commerce Drive facility located in Bedford, New Hampshire. This new space is intended to accommodate clients' increased needs for validated storage capacity. The expansion provides for short and long-term cGMP storage of controlled room temperature, refrigerated, and frozen (-20oC and -80oC) temperature-sensitive products. "The 7 Commerce Drive facility is equipped with validated storage chambers, redundant refrigeration systems and backup generators that are continuously monitored and supported by 24/7 on-site supervision. All of LSNE's cGMP facilities and equipment are designed with a high level of redundancy that reduce risks to our clients' valuable products," said Damon Abernathy, Vice President of Operations at LSNE.
This capability compliments the adjacent QC laboratory to support LSNE's growing analytical and microbiology testing services and offer integrated storage options. This creates a convenient solution that addresses our clients cold chain storage requirements. As LSNE-Bedford continues to further support our clients' changing needs, this valuable service will be instrumental to managing the entire supply chain more efficiently.
In addition to the validated storage capabilities, the expansion added larger ICH stability chambers for all standard storage conditions including -20°C, 2-8°C, 25°C/60%RH, 30°C/65%RH, 40°C/75%RH. "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," said Shawn Cain, Chief Operating Officer at LSNE.
LSNE is a privately held company with six GMP facilities – four located in New Hampshire, one in Wisconsin and one located in León, Spain. LSNE has been providing contract manufacturing services to the pharmaceutical, biotechnology and medical device industries since 1997, specializing in a wide range of services including process development, cGMP fill finish and lyophilization (for vials, pre-filled syringes and dropper bottles), analytical testing services and regulatory support. Through the thoughtful integration of six processing facilities, qualified staffing, and an extensive manufacturing history, LSNE is strategically positioned to provide products and services for clinical through commercial supply for pharmaceuticals and medical devices to a multi-national market.