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Process Development

The goal of the process development group is to help cell, tissue, organs developers by providing the expertise and resources to achieve scalable, consistent and cost-effective manufacturing. The work conducted by this group prioritizes process gaps analysis, simplification, optimization and eventual automation. Process development work begins with the Tech Transfer of the existing process to gain a deep understanding of the product and process. We then conduct a risk assessment and gap analysis to prioritize process improvements. Process development studies are conducted alongside any process changes or equipment development necessary to achieve the SMAC version of the manufacturing process. The SMAC process is then qualified with process samples analyzed by the DTCC. What distinguishes our work is that we are not simply converting a process to GMP, but we are evaluating our partner’s process and adapting it so that the process will scale into commercial production and partners will have a robust understanding of their process. We engage with cell, tissue, and organ developers early in their product life cycle (pre-clinical or clinical I/II) so they are adequately prepared to scale their process in a cost-effective and consistent manor, increasing the likelihood for speedy regulatory review and commercial viability.