Developing cell and gene therapies (CGTs), from discovery to commercialization, is highly complex. Further, as this sector continues to mature many process parameters will remain ill-defined. This can make it difficult to forecast budgets for development and manufacturing. There are many reasons why budgeting requires flexibility, from the need to adhere to nuanced regulations, to meeting demanding investor and leadership team timelines.
Here, we have assembled five tips to help maximize the value of your chemistry, manufacturing and controls (CMC) budget and stay on track to meet development milestones.