In October, Lonza has announced Swissmedic approval for its new aseptic drug product filling line in Stein (CH), designed specifically for biologics and highly potent products such as antibody-drug conjugates (ADCs). The approval marks the operational readiness of a state-of-the-art facility that expands Lonza’s capacity for both liquid and lyophilized vial filling while incorporating advanced containment technology to safely handle potent compounds.
Michael De Marco, Vice President, Head of Commercial Development, Integrated Biologics, commented: “This milestone reinforces our commitment to providing fully integrated solutions for highly potent biologics. By streamlining the pathway from development to commercialization, we enable our customers to bring innovative therapies to patients more efficiently.”
The new line meets GMP Annex 1 requirements for sterile manufacturing and supports clinical and commercial supply across diverse biologic modalities, including monoclonal antibodies, bi-specific antibodies, and ADCs. This expansion strengthens Lonza’s integrated end-to-end solutions across the biologics and bioconjugates value chain, connecting drug substance and drug product capabilities under one roof.
With this latest addition, Lonza continues to solidify its position as a leading CDMO, offering customers a seamless and efficient path from development to market for highly potent biologics.