Optimizing Processes & Accelerating Success: In Cell and Gene Therapy Development and Manufacturing
Cell and gene therapy companies are rapidly moving toward larger scale manufacturing operations. Their success is highly dependent upon optimizing processes to minimize the elapsed time between apheresis and the therapeutic injection. The goal of CAR T 2.0 and next generation TCR, TIL, and mRNA treatments is to elevate autologous and allogeneic therapies as viable alternatives to existing treatments by applying proven manufacturing processes and exhausting every avenue to decrease payer costs. Yet many barriers stand in front of wide scale adoption of cell and gene therapies including cell type variability, process robustness, and stakeholder buy in. Importantly, vein-to-vein time for autologous therapies and creating effective off-the-shelf products for allogeneic treatments is governed by how closely cell and gene therapy manufacturers orchestrate process development and tech transfer across the supply chain. To attain lean cell and gene therapy manufacturing, treatment developers should adopt a process information system that creates a digital data spine early in process and product development to establish a persistent, dynamic knowledge library throughout the product life cycle.