Simplify your biologics supply chain
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:
- Vial filling
- Pre-filled syringe and cartridge filling
- Vial lyophilization
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.
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.
- Advanced chromatographic and spectroscopic platforms, including HPLC, UHPLC, and LC–MS, to support impurity profiling and product characterization.
- Particle and sub-visible particle analysis, container-closure integrity testing, and visual inspection support aligned with regulatory expectations.
- Automated analytical systems and robust data infrastructures designed to support compliance, traceability, and data integrity.
- Method development, qualification, and validation, including for new and complex molecular formats.
- Close collaboration with drug substance teams and customers to define shelf life, specifications, and phase-appropriate, lifecycle-focused control strategies.
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.
We manufacture a wide range of parenteral drug product formats, including liquid and lyophilized vials, pre-filled syringes (PFS), and cartridges. Our capabilities span biologics modalities from monoclonal antibodies to complex biologics including bioconjugates, highly potent products and antibody drug conjugates.
Our dedicated technology transfer teams have delivered more than 150 successful transfers over the past 5 years. We leverage integrated drug substance and drug product capabilities, predictive tools, and purpose-built facilities. We offer accelerated or fully tailored clinical and tailored commercial programs, supported by regulatory expertise.
Yes. We provide phase-appropriate non-GMP manufacturing for toxicology, stability, and manufacturability studies. These services are designed to accelerate development timelines and support smooth progression to GMP manufacturing within our global biologics manufacturing network.
We offers comprehensive quality control services, including method development and validation, shelf-life definition, specification setting, and control strategy development. Our in-house capabilities and experienced teams prioritize compliance throughout the biologics manufacturing.
Our global drug product network offers flexible capacity across scales, formats, and potency ranges throughout the product lifecycle. Integrated with drug substance (DS) capabilities and supported by advanced technologies and expert teams, we help simplify supply chains, reduce CMC risk and deliver reliable biomanufacturing solutions.
