Upgrading The Vial/Vein-To-Vein Process with Enterprise-Level Digital Infrastructure

The cell and gene therapy (CGT) industry is at the forefront of medical innovation, offering the promise of curing previously untreatable diseases but is faced with a complex value chain to convert raw materials into lifesaving treatments. This value chain has come to be known as the vein-to-vein or — in the cases of iPSC-derived and viral vector therapies — vial-to-vein process for products that begin with tissue collected from a patient or volunteer donor and is infused into the patient as a live pharmaceutical product. The unique characteristics of variable inputs and the limited characterization of manufacturing processes of a nascent industry add increased difficulty to ensuring patients consistently receive a quality product. While we are progressing toward advanced analytical techniques and direct process validation, we lack the digital governance to associate critical parameters spread across the entire value chain to patient outcomes. The three main contributors, medical providers, product manufacturers, and logistics carriers, operate on isolated systems with minimal integration. Integrating these digital systems with an enterprise-level digital infrastructure can significantly improve reliability across the value chain, provide transparency for all stakeholders, and accelerate innovations in product and component characterization.

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