Lonza Receives Swissmedic Approval for Highly Potent Biologics Drug Product Filling Line in Stein (CH)

Lonza, announced the operational readiness of its new aseptic drug product filling line in Stein (CH). The filling line was granted a GMP license following Swissmedic approval, strengthening Lonza’s existing capacity for liquid and lyophilized vial filling while introducing advanced containment technology to safely manufacture highly potent biologics.

With the latest generation of containment and isolator technology, the new line fulfills the GMP Annex 1 requirement for the manufacture of sterile products. Powered by leading manufacturing experts, this line can support customers with clinical and commercial supply across a wide range of biologics modalities, including monoclonal antibodies, bi-specific antibodies, and ADCs.

This expansion also enhances Lonza’s growing drug product manufacturing capacity in Basel (CH) and strengthens its integrated end-to-end offering for biologic-based therapeutics.

Michael De Marco, Vice President, Head of Commercial Development, Integrated Biologics, Lonza, said: “The completion of our new drug product manufacturing line in Stein marks a significant milestone in our commitment to providing fully integrated end-to-end solutions for highly potent biologics such as ADCs. By seamlessly connecting drug substance and drug product capabilities within a single partner, Lonza enables customers to benefit from a streamlined and efficient pathway to commercialization.“