Trusted long-term partnerships to support your evolving needs while simplifying your biologics supply chain.
We provide Annex 1 compliant manufacturing across the product lifecycle, supported by a comprehensive suite of development and specialized support services. Integrated with our drug substance network and enabled by advanced technologies and deep expertise, we help reduce CMC risk and reliably manufacture high-quality biologics.
Our site in Stein, Switzerland, is undergoing a major expansion to support large-scale biologics drug product manufacturing. Scheduled to open in Q4 2027, the 20,000-square-meter facility will feature advanced automation and precision technologies for:
Supported by a CHF 500 million investment, the expansion will deliver scalable, technology-enabled solutions integrated into our global biologics network. The site is designed to help mitigate CMC risks, simplify supply and meet evolving commercial demands.
Sustainability is embedded into the facility design, with a focus on reducing environmental impact through pollution reduction, renewable energy adoption, and energy-efficient operations.
A highly skilled, integrated team working in close collaboration to reliably manufacture your biologics drug product. GMP operations in Stein and Visp support a broad range of biologics presentations, including liquid and lyophilized vials, prefilled syringes and cartridges. These capabilities are complemented by development and manufacturing support services from our Center of Excellence in Basel.
Our tech transfer expertise combines a highly skilled MSAT team, enhanced by a global network with integrated drug substance and drug product expertise. With more than 150 successful biologics drug product transfers in the past five years across biologics modalities, and enhanced by predictive tools and advanced technologies, we drive complex transfers across modalities and potency levels. Our programs range from accelerated clinical programs to flexible, customized clinical, BLA, and sBLA tech transfers—shaped around your specific needs.
We help you advance development with non-GMP manufacturing services that enable toxicology, stability and manufacturability studies as well as formulation and presentation development.
Our flexible formats include vials, prefilled syringes, cartridges, and ampoules, covering a wide potency range, including highly potent products.
With more than 140 batches executed and a 100 percent success rate, we help accelerate development and enable seamless transfer to GMP manufacturing. Our services are supported by on-site formulation, process development, and analytical expertise.
We operate dedicated in‑house analytical laboratoires equipped with state‑of‑the‑art technologies and deep scientific expertise to allow products to meet safety, efficacy, and regulatory expectations.
Unexpected particle contamination can delay batch release, result in costly product loss and disrupt supply. Between 2017 and 2021, visible particles accounted for approximately 33% of sterile drug product recalls, underscoring the importance of rapid and reliable investigation.1
The Lonza Forensics-On-Demand® program is a flexible subscription service that provides rapid, on-demand access to expert particle identification capabilities, helping accelerate root cause investigations and support timely, informed batch decisions. Enabled by deep scientific expertise, advanced analytical technologies and extensive reference libraries, the program is delivered through a streamlined digital process designed to support regulatory compliance and supply continuity.
1 Data obtained from the FDA Recall and Safety Alerts Archive
Visual inspection (VI) is essential for parenteral drug products to identify particle contamination and packaging defects. Whether manual or automated, effective inspection depends on trained operators, qualified equipment, and high-quality test sets.
We design, manufacture, and certify visual inspection test sets across biologics modalities, supported by advanced forensic analytics. These test sets help qualify inspection processes and equipment, supporting consistent compliance and patient safety.
