Fraunhofer IZI, one of Europe’s leading manufacturers of cell and gene therapies for clinical trials, intends to digitalise its manufacturing operations with Moda-ES, the manufacturing execution system (MES) from Lonza. Fraunhofer IZI will use Lonza’s the MES to facilitate its transition from an entirely paper-based, manual documentation process to an automated, fully electronic GMP-compliant system.
Manufacturing cell and gene therapies – advanced therapy medicinal products – requires extensive documentation of all manufacturing and verification steps to ensure patient safety and GMP compliance. For organisations with complex workflows, selecting the right electronic batch record solution is critical.
Dr Gerno Schmiedeknecht, Head of the Department GMP Cell and Gene Therapy, Fraunhofer IZI, commented: “With the introduction of fully electronic batch documentation, manufacturing and batch release for our customers and partners will be even safer, faster, more cost-effective and generally more efficient. In addition, this measure leads to higher flexibility in a potential pandemic situation, as the process of reviewing the batch documentation and the batch release, in particular, can largely be carried out in remote mode without direct onsite presence.”
David McErlane at Lonza added: “We are excited to support Fraunhofer IZI with their Moda-ES Implementation. Electronic batch records have been unattainable to most of the industry due to cost constraints and flexibility concerns. With a deep understanding of the challenges faced by cell and gene manufacturers, we designed Moda-ES with the end user in mind to provide a cost-effective and usable solution that meets our customers’ requirements.”