PCI Pharma Services (PCI), has signed a definitive agreement to acquire Lyophilization Services of New England, Inc. (LSNE), in Bedford, New Hampshire, from global private equity firm Permira, to add end-to-end global sterile fill-finish and lyophilization manufacturing capabilities

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.

LSNE will expand PCI's breadth of services as a global CDMO, building on PCI's expertise in biologics packaging and specialty manufacturing. The acquisition adds FDA-approved facilities in the U.S. (New Hampshire, Wisconsin) and Europe (Spain), with a sixth expecting approval over the coming months, and three additional facilities under development, to strengthen PCI's global 30-site network.

LSNE New Hampshire campus includes medical device and aseptic fill finish and lyophilization facilities located in Manchester's tech hub and Commerce Park in Bedford.

LSNE-Madison is located near the University of Wisconsin in Research Park, one of the biotech hubs of Madison, Wisconsin. LSNE's third aseptic fill finish and lyophilization .

LSNE-León is located in León, Spain, two hours northwest of Madrid. The aseptic fill finish and lyophilization facility expands LSNE's sterile fill finish capabilities to include pre-filled syringes and dropper bottles and offers additional capacity for liquid and lyophilized vial presentations.

In October 2021, LSNE has doubled its sterile drug product lyophilization capacity at its Madison, Wisconsin parenteral manufacturing facility, with the installation of a new lyophilizer. The Madison capacity increase is one step in a strategic company-wide lyophilization expansion plan adding capacity to all existing facilities.

As a leader in lyophilization services, LSNE is capitalizing on its expertise and high-speed fill line at the Wisconsin cGMP sterile drug product manufacturing facility to bring on a new 120 ft2 commercial lyophilizer. This new lyophilizer is equipped with redundant systems to best protect high value Active Pharmaceutical Ingredients (APIs) and doubles the lyophilization capacity at the site. This added capacity will help address long industry timelines for lyophilization and support our clients ever-increasing capacity demands.

With the addition of LSNE, PCI will be able to offer integrated large and small molecule solutions for its clinical and commercial clients. This includes expanded global manufacturing capabilities in complex formulations, high potency, and now lyophilization for a broad range of injectables including nanoparticles, mRNA, mABs, proteins, oligonucleotides, and other biologics across formats from vials and bottles to pre-filled syringes and autoinjectors.

LSNE marks PCI's fourth acquisition in three years, exemplifying PCI's enhanced focus on global specialty manufacturing capabilities while complementing its existing clinical and commercial packaging expertise.

In February 2020, PCI Pharma Services (PCI), announced the acquisition of Bellwyck Pharma Services (Bellwyck), headquartered in Toronto, Canada. With 25 years of experience, Bellwyck is a leader in primary and secondary packaging and labeling for clinical trial and commercial drug markets. The acquisition of Bellwyck to establish a presence in Canada and Germany further underscores PCI's global strategy and commitment to be the partner of choice to meet the market needs of its clients..

PCI spans a global footprint of 25 GMP facilities across six countries and employs ~3900 people worldwide.

RELATED Alcami expand its sterile manufacturing operation in Charleston

---