LSNE's León biotech facility approved by Spain's regulator

LSNE Contract Manufacturing says 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.