Global API development and production
Built and operated to Lonza's exacting global standards, our Nansha (China) facility offers high-quality, scalable manufacturing services at all stages of the API development cycle. The site is a critical component of our global services network for small molecule API and intermediates. Together with our Visp (CH) site, we offer highly flexible and scalable manufacturing services across a wide range of chemistry tailored to your specific project needs. Global supply chain infrastructure and management is in place to ensure excellent supply security to our customers around the world.
Our Nansha site is also utilized extensively for rapid API manufacturing for early phase studies. With advanced instrumentation and dedicated laboratories and personnel, we offer an extensive package of R&D services inclusive of:
- Route scouting and feasibility studies
- Development, optimization and technology transfer of chemical processes
- Process development and optimization
- Impurity profile studies
- Purification and isolation of non-solid product
These capabilities are an integral component of our SimpliFiH® Solutions first-in-human services package.
Analytical development and QC teams are also in place for method development, validation, transfer of API and intermediates, and to ensure the accuracy of product analysis. State-of-the-art instrumentation and electronic data systems ensure data integrity to global standards.
The Nansha site is an integral component of our global drug substance and drug product design, development and manufacturing network. This network complements our historical API leadership, and includes world-class particle engineering and specialized drug product formulation services across oral, inhaled and parenteral applications inclusive of:
- Antibody drug conjugates
- HPAPI / low dose applications
- Bioavailability enhancement
- Advanced drug delivery
- Dry powder inhaler applications
Leveraging these global capabilities, we tailor our services to your specific molecule and drug program needs, overcome formulation challenges and minimize timelines, complexity and risk.