LSNE Expands Vial Fill Finish and Lyophilization Operations with New Automated Fill Line
Bedford, NH Campus – Adds Ready-to-Use Aseptic Filling and Freeze-Dryer Capacity
January 14, 2021, Bedford, NH – LSNE Contract Manufacturing, a leading contract development and manufacturing organization (CDMO) expands vial filling and lyophilization capacity with the addition of a new automated aseptic fill line. The new aseptic fill line will be housed in an existing ISO-5 clean room suite at the 25 Commerce Drive facility in Bedford, NH. The multi-product fill line serves to increase capacity and flexibility for manufacturing high-value APIs to meet the demand in drug product manufacturing driven by the Covid-19 pandemic. Specifically, this manufacturing suite is designed to support products that require minimal process loss because of API availability or high cost. For instance, the new fill suite features in-line (non-destructive) weight checks and fully disposable formulation and manufacturing materials, minimizing line loss, thus conserving precious product for every batch.
“LSNE continues to innovate and expand our global capacity and capabilities to better serve pharmaceutical companies with their ever changing clinical and commercial programs. By investing in this new GMP sterile fill finish capacity on our Bedford, New Hampshire campus, we continue to execute on our corporate growth strategy and better serve our client’s needs, especially where product loss is a key consideration,” said Shawn Cain, Chief Operating Officer. The new fill suite is scheduled to be qualified and ready for contract cGMP manufacturing in Q3 2021 increasing LSNE’s capacity by up to 100 additional aseptic manufacturing lots per year.
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 lyophilization services to the pharmaceutical, biotechnology, and medical device industries since 1997, specializing in a wide range of services including process cycle development, fill-finish and lyophilization (for vials, pre-filled syringes and dropper bottles for ophthalmics), and analytical testing. Through the thoughtful integration of six processing facilities, qualified staffing, and extensive manufacturing history, LSNE is strategically positioned to provide products and services for clinical through commercial supply for pharmaceuticals and medical devices to a global market.