The major key cost drivers of the autologous CAR T-cell therapy are generally QC analytics and biocharacterization of viral vector and supporting starting biomaterials, all of which could be outsourced costs or could be developed and managed in-house.

The cost and impacts revealed through the decision-making process emphasize the need for automation.

    Compared to traditional biologics, the scale-out process is highly dependent upon the qualification to achieve Fit-to-Process, existing bottlenecks, and available systems suitability.

    The aim of this discussion is to provide insight into CoGs, lifecycle, and supply chain costs for these expensive cell therapies. Therefore, small-to-large regenerative medicine companies can investigate straight-to-point dynamic criteria set by QA and QC processes and allow feasibility assessments to be made regarding the viability of alternative technologies and process options.

    Categories: Health Care