Lonza Secures Swissmedic Approval for Stein Facility

Lonza Secures Swissmedic Approval for Stein Facility

India Pharma Outlook Team | Thursday, 09 October 2025

 Lonza

Lonza, a global leader in contract development and manufacturing (CDMO), has declared that the operational readiness of its new aseptic drug product filling line at its Stein, Switzerland site is in place.

This line has been granted a GMP approval by Swissmedic, thereby increasing Lonza's filling capacities for both liquids and lyophilized vials while at the same time allowing the implementation of cutting-edge containment technology for the safe handling of highly potent biologics.

New generation isolator and containment systems have been installed in the Stein facility to meet high standards of GMP requirements for sterile product manufacturing. The line is intended to provide biological solutions with a broad range of modalities such as monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates (ADCs), thus offering scalable solutions for clinical and commercial supply.

This reinforcement of the Lonza drug product manufacturing in Basel is aligned with the intention of the company to become a more integrated end-to-end solution provider for biologic-based therapeutics. The combination of drug substance and drug product led under one partner is the way that Lonza has chosen to offer a more convenient and time-saving program to its customers.

Michael De Marco, Vice President and Head of Commercial Development, Integrated Biologics, said: “The construction of the Stein site new drug product manufacturing line is a momentous landmark in our pledge to provide fully integrated end-to-end solutions for highly potent biologics such as ADCs.

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This plant facilitates the utilization of the drug substance and drug product capabilities, which ensures that the customers get the benefits of the fastest and most apposite routes to the market.”

Lonza has consolidated its status as a partner of choice for the development and manufacturing of biologics with this strategic expansion, which supports innovation and the accelerated global accessibility of advanced therapeutics.

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