LSNE Completes PAI at Bedford Facility

Lyophilization Services of New England, Inc. (LSNE) has completed a successful Pre-Approval Inspection (PAI) and GMP inspection, clearing the way for the company to manufacture commercial drug product for U.S. distribution. This is the second PAI at the Bedford, NH facility. The first inspection was for a bulk drug intermediate lyophilized in LSNE’s 260 sq.-ft. lyophilizer.

Shawn Cain, chief operating officer of LSNE said, “The completion of this inspection is a critical milestone for LSNE as it is the first PAI for a sterile product at the 25 Commerce Road facility. This is also our second site to now be successfully inspected by the FDA to produce commercial products in the past few months. This demonstrates LSNE’s commitment to meeting all applicable regulatory standards for the production of commercial medical devices, bulk intermediates and sterile injectable drugs.  It is only through the talent and dedication of our staff that we have been able to achieve and maintain this level of compliance.”

Additionally, LSNE is adding capabilities across three sites including the expansion of QC analytical testing capabilities, ICH stability chambers, additional complex formulation capabilities, as well as increased manufacturing capacity.