- Lonza has received Swissmedic approval for its new aseptic drug product filling line in Stein, Switzerland.
- The line introduces advanced containment technology for highly potent biologics and expands the company’s liquid and lyophilized vial filling capacity.
Lonza, a global CDMO, has announced the operational readiness of its new aseptic drug product filling line in Stein, Switzerland, following Swissmedic approval and GMP licensing. The expansion adds advanced containment technology to the company’s existing capacity for liquid and lyophilized vial filling and supports the manufacture of highly potent biologics.
The new line meets GMP Annex 1 requirements for sterile product manufacturing and is equipped with the latest isolator and containment technologies. It can accommodate a range of biologics modalities, including monoclonal antibodies, bi-specific antibodies, and antibody–drug conjugates (ADCs), supporting both clinical and commercial supply.
This development builds on Lonza’s existing drug product manufacturing footprint in Basel, strengthening the company’s integrated end-to-end offerings for biologic-based therapeutics. By connecting drug substance and drug product capabilities within a single partner, Lonza aims to streamline the pathway from development to commercialisation.
“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.”
Michael De Marco, Vice President, Head of Commercial Development, Integrated Biologics, Lonza
