LSNE Contract Manufacturing said 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 approval builds upon LSNE’s well-established capabilities in providing aseptic fill finish of biologic products for clients at its U.S. 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,” said Shawn Cain, chief operating officer, LSNE. “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.”
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.”