Nansha, China

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.

Rapid scale-up and commercial production

The Nansha site is equipped to take your molecule from concept to commercialization. Our early-phase or small-scale plant creates a phase-appropriate bridge between kilo-lab capabilities and commercial-scale production.  World-class large-scale production is in place to meet late-phase clinical and commercial requirements.  

• Small-scale plant: 10 reactors (250L)
• Large-scale plant: 3 multi-purpose production trains (10000L)

With Nansha’s excellent compliance record and inspection history from global regulatory authorities (FDA, PMDA, MPA), you can have confidence that your products are produced to global regulatory standards. Together with the Visp site, our proven track record in rapid development and scale-up supporting accelerated regulatory file submissions has been established.

Services

Our Nansha team is equipped to provide fully integrated, world-class API and advanced intermediates development and manufacturing.

• Dedicated R&D and technical services support pre-clinical and early phase projects with extensive experience across a full array of synthesis routes.
• Early phase manufacturing creates a bridge between kilo-lab and commercial production, and serves to support accelerated regulatory filing submissions and facilitate rapid scale-up
• Large-scale manufacturing is in place with an extensive range of reactors and multiple independent production lines to support late-phase clinical and commercial production of API and advanced intermediates
• Analytical development and QC services provide full analytical method development and validation, technology development and transfers, and product analyses using state-of-the-art instrumentation and data management systems.
• Regulatory services provide extensive support for drug registration and dossier preparation, submission and maintenance throughout the life cycle of an API aligned with individual customer requirements