Lonza Gets Swissmedic Nod for New Aseptic Drug Product Filling Line
Located in Stein, Switzerland, the new GMP licensed line will enable the company to provide integrated, end-to-end solutions for the whole biologics and bioconjugation value chain.
Global CDMO, Lonza, has revealed that its new aseptic drug product filling line in Stein, Switzerland, is now operational ready after having been granted approval from Swissmedic for a good manufacturing practice (GMP) license (1). The new filling line is designed for biologics and highly potent products, such as antibody drug conjugates (ADCs).
Featuring the latest generation of containment and isolator technology, the new line fulfills the requirements of the GMP Annex 1 guidance and can support customers with clinical and commercial supply across a wide range of biologics modalities. Additionally, the line strengthens Lonza’s existing capacity for liquid and lyophilized vial filling.
“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,” said Michael De Marco, Vice President, Head of Commercial Development, Integrated Biologics, Lonza, in a company press release (1). “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.”
Back in November 2024, Lonza announced its plans to invest in additional bioconjugation capabilities in Visp, Switzerland to meet growing market demand. The investment was used to add two multipurpose 1,200 L manufacturing suites and manufacturing-related infrastructure to the company’s existing facility located in Visp (2).
“We continue to see strong growth in the bioconjugates space as ADCs and other bioconjugated drugs increasingly progress towards commercialization,” commented Christian Morello, Vice President, Head of Bioconjugates, Lonza, in a company press release about the expansion (2). “This investment in our multipurpose commercial bioconjugation capacity addresses the growing market demand, enables us to support the growth of our customers and offers a flexible and integrated service for manufacturing bioconjugates.”
According to market research, the global bioconjugation market is experiencing significant growth, with the market value projected to reach USD 23.18 billion by 2034 — increasing at a compound annual rate of 15.46% during a 9-year period (3). Within this market, the services sector is expected to experience the fastest growth, owing to the fact that more pharmaceutical and biotech companies are outsourcing to help speed up their drug development and reduce costs and the burden on internal resources. Outsourcing partners that offer specialized capabilities in complex bioconjugation processes, such as ADC development, will benefit from the expanded demand from industry.
References
Lonza. Lonza Receives Swissmedic Approval for Highly Potent Biologics Drug Product Filling Line in Stein (CH). Press Release, Oct. 8, 2025.
Lonza. Lonza to Expand Bioconjugation in Visp (CH) with Two Additional Manufacturing Suites. Press Release, Nov. 12, 2024.
Towards Healthcare. Bioconjugation Market 2025 CRO/CDMO Segment to Outpace Industry with Rapid Expansion. Market Research Report, Aug. 11, 2025.