Lyophilization Services of New England (LSNE) has acquired a sterile injectables manufacturing facility located in León, Spain, expanding its full-service manufacturing capabilities into Europe.
 
In addition to adding pre-filled syringe, ophthalmic and sterile bulk lyophilization capabilities, the new facility will also focus on pharmaceutical products that have complex requirements such as emulsions, suspensions, liposomal formulations and nanoparticle products. The facility includes four high speed, automated aseptic fill lines and commercial scale lyophilization for the manufacture of clinical and commercial drug products.  
 
“Acquiring this high quality facility in León was the logical next step in our growth strategy given our strong and growing client base in Europe,” said Matthew Halvorsen, chief executive officer at LSNE.  “This new location will enable us to better serve clients by leveraging our successful regulatory history and expertise in sterile drug product manufacturing to provide them with the highest level of compliance and support.  We are excited to welcome the talented team in León, and believe there is tremendous potential for future success.”
 
In April 2018, LSNE acquired a 37,000 square foot cGMP aseptic fill finish facility in Madison, WI. “With the Permira funds’ support, LSNE continues to execute its strategy and pursue its growth opportunities through capacity expansion, enhancing existing infrastructure, investing additional capital in state-of-the-art equipment, and growing personnel over time,” said Shawn Cain, chief operating officer at LSNE.  “We continue to see increasing demand for sterile liquid and lyophilization manufacturing services across our growing client base, and look forward to having additional capacity to offer our clients a variety of sterile dosage forms.” 
 
LSNE-León facility, located northwest of Madrid, has recently completed both FDA and Spanish Agency of Medicines and Medical Devices (AEMPS) inspections, and is able to support large-scale commercial production in both the U.S. and EU.