Lonza offers global cGMP-compliant cell therapy manufacturing with manufacturing sites in North America and Asia.
Lonza has experience with multiple platforms of closed-system processing for both adherent and suspension cell culturing strategies. Our innovation center develops closed systems and integrate best in class technologies, and invent new technologies and devices where needed, in order to achieve closed systems from the cell bank thaw through to product fill and finish.
Our U.S.-based suites currently comply with ISO Class 7 (Class 10,000) classification to meet U.S. requirements, and we offer suites with ISO Class 5 (Class B) compliance for European needs. From the unidirectional flow design for materials and personnel to the equipment we utilize, the suites are engineered with exceptional quality in mind. Flexibility in design permits us to configure the suites to meet unique customer needs and optimize productivity. Each suite boasts a dedicated air-handling system, as well as a separate air-handling system for common areas, thus preventing cross-contamination. Additionally, every suite features its own dedicated cleaning and environmental monitoring equipment, as well as alarmed backup equipment.
We are exceptionally cognizant of the need to segregate projects, and are fastidious about protecting our client's product, as well as their process. At the conclusion of each project, validated changeover and cleaning procedures are implemented, culminating in the Quality Assurance organization releasing the suite for use for each individual project. All of this translates to ensuring the integrity of their product and consistently meeting customer expectations with efficient systems and high quality results.