CELLforCURE by SEQENS, a leading contract development and manufacturing organization (CDMO) for cell and gene therapies, has chosen to implement Körber’s PAS-X MES 3.3 as a crucial component of its digitalization strategy for manufacturing, traceability and documentation processes.
As a specialized CDMO, CELLforCURE by SEQENS needed a digital solution to ensure seamless technology transfer and process validation for its clients, supporting clinical & commercial supply, as well as an efficient batch information exchange system with its customers. Given the highly personalized nature of cell and gene therapies, characterized by small batch sizes and time pressure, it was also essential to reduce the effort required for handling and documentation, lower operational costs, and secure reliable IT support.
“We chose PAS-X MES because we believe it offers the best functional coverage in a SaaS environment compared to other solutions. By leveraging an MES as a service, we no longer need to manage IT infrastructure internally. This solution permits to ensure lean and compliant processes for patients’ batches manufacturing and release. We will be able to exchange data with our customers very effectively”, says Nathalie Lelot, Operations Head at CELLforCURE by SEQENS.
PAS-X MES is being deployed as a standard out-of-the-box SaaS solution, hosted in an AWS cloud environment and fully managed by Körber. It covers Master Batch Record (MBR) design, execution, and documentation. The system integrates with scales and printers and is connected to the SAP ERP system via SAP MII. Körber’s PAS-X Data Access will also be utilized to provide curated data for Power BI analysis, enabling the establishment of KPIs and further process optimization.
