LSNE-León Receives Approval from AEMPS to Manufacture Biotechnology Based Therapeutic Products
LSNE Expands Capabilities for Aseptic Fill Finish of High-Value Biologics in Europe
August 27, 2020, Bedford, NH – LSNE Contract Manufacturing, a leading contract development and manufacturing organization, is pleased to announce that the Spanish Agency of Medicines and Medical Devices (AEMPS) has approved the manufacturing of clinical stage biotechnology based therapeutic products at its aseptic fill finish facility in León, Spain. This important approval builds upon LSNE’s well-established capabilities in providing aseptic fill finish of biologic products for clients at its US facilities. These products include monoclonal antibodies, fusion proteins, replacement enzymes, plasmids, capsids, and oligonucleotides.
“The authorization of biologic manufacturing for clinical drug product in both vial and pre-filled syringe (PFS) presentations is a vital step to our maturation of drug product manufacturing at our facility in Spain. This will provide the global market with more access to LSNE facilities for the manufacture of these high-value biologics, including monoclonal antibodies and other recombinant proteins,” said Shawn Cain, LSNE’s Chief Operating Officer.
Jaime Del Campo, Site Head at LSNE-León said, “We are thrilled with this most recent milestone and our ongoing partnership with AEMPS. This is another big step forward supported by our industry leading quality and operations teams. We anticipate this authorization will have an immediate impact in our ability to support our client’s varied clinical programs and ensures long-term benefits to their future commercial supply.”
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.