Through the installation of MODA-ES®, the Champalimaud Foundation plans to improve and streamline the cell therapy manufacturing process, thereby increasing accessibility of life-saving therapies for patients with cancer with unmet medical needs.
In collaboration with academic and industry partners, the Champalimaud Foundation has built a state-of-the-art multipurpose GMP facility to develop biologically and clinically promising cell therapies with industrial standards. The foundation sought a paperless solution to ensure the safety of cell production, unlock transparency for current and future partners, and monitor the complex production process from reagent purchase to final product release.
Based on these requirements, the Champalimaud Foundation selected Lonza’s MODA-ES® Platform. This configurable manufacturing execution system (MES) is designed specifically for cell and gene therapy production. It consolidates all manufacturing batch and batch-related quality control data into a single record for reduced errors, greater visibility, and expedited product release. The platform provides advanced traceability and genealogy workflows, which helps to ensure the chain of identity and custody in complex decentralized cell and gene therapy manufacturing processes.
The Immunotherapy expert team at Champalimaud chose the Lonza MODA-ES® Platform owing to Lonza’s proven track record in e-solutions that cover the cellular production process and that provide vital links to the entire operational system of a GMP facility. Lonza’s deep understanding of cell production, academic medicine, and how to develop and implement electronic documentation solutions is of great benefit to companies implementing an MES in cell and gene manufacturing while it creates increased transparency for regulatory agencies.
Orla Cloak, Senior Vice President, Head of Bioscience, Lonza, commented: “We are committed to supporting our customers in bringing innovative cell and gene therapies to their patients. This commitment relies on our capability to offer the right expertise and tools, including MODA-ES®. We are also proud to support our customers with an experienced implementation team that understands the intricacies of cell and gene therapy manufacture and can help to accelerate the path to market for these novel therapies.”
Additional Information
To learn more about Lonza’s MODA-ES® Platform for cell and gene therapy, visit:
bioscience.lonza.com/the-moda-es-platform-mes-for-cell-and-gene-therapy