Lyophilization Services of New England (LSNE) has completed two FDA inspections of their aseptic manufacturing facilities. These inspections were conducted in January and February of 2017. The first inspection was an FDA Pre-Approval Inspection (PAI) of their aseptic manufacturing facility located at Commerce Drive in Bedford, NH. As a result, the Commerce Drive facility has been recommended for approval to manufacture the commercial sterile drug product for U.S. distribution.   This PAI, which also served as a general GMP inspection, included both the multi-product aseptic manufacturing site as well and the supporting QC laboratories. The second inspection was a general GMP inspection of LSNE’s Harvey Road aseptic manufacturing facility, which is also located in Bedford, NH. The Harvey Road facility is dedicated to the aseptic filling and lyophilization of a product that is commercially approved by the FDA and currently on the market. Both inspections resulted in no Form 483 being issued for either facility, as there were no observations noted by the FDA.

“We are very pleased with the positive results of the latest FDA inspections of our two aseptic manufacturing sites and supporting QC laboratories,” said Shawn Cain, chief operating officer, LSNE. “We are proud to say that the most recent inspections of our three manufacturing sites have all resulted in no observations. This also marks the second consecutive inspection of the Harvey Road facility with no observations and the second consecutive recommendation for approval at the Commerce Drive location. We believe that our compliance history demonstrates our commitment to constantly improve our systems and to staying current with the ever changing regulatory landscape.”

LSNE has added additional capabilities across all three of their manufacturing sites in 2016 and says they plan to continue expanding in 2017. The 2017 master plan includes expansion of its QC laboratory and centralized warehousing with expanded cold chain capabilities, additional complex/potent compound handling capabilities, as well as increased large-scale commercial fill/finish and lyophilization capacity.