Gradalis develops personalized cancer therapeutics, including Vigil®, which requires a fully autologous manufacturing process. Before adopting L7|ESP, Gradalis relied on paper-based batch records, manual calculations, handwritten observations, and siloed forms used to control each step of the manufacturing process. This created challenges in tracking materials and samples, maintaining accurate chain of custody and identity, and consolidating critical data into a single, compliant system.
Gradalis implemented L7|ESP as a validated, regulatory-compliant platform to integrate data across manufacturing, QC, and clinical operations. The system digitalizes and automates workflows, unifies information from disparate instruments and quality systems, and provides complete operational traceability across the product lifecycle.
Since deploying L7|ESP, Gradalis has successfully used a “Paper on Glass” approach supported by barcoding, automated sample tracking, and electronic batch production records. The platform maintains full chain of identity and chain of custody, incorporates instrument data directly into batch records, and provides a complete history of each product from origin through disposition. L7|ESP enables greater compliance, efficiency, and control across Gradalis’ multi-day manufacturing and quality processes.
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