Developing a long-term manufacturing-ready process for gene therapy and viral vaccine products can be a challenge for a number of reasons. First-in-human trials require developing a process with limited knowledge, and success metrics are unknown (e.g., assays to measure success have not yet been developed). In addition, the components of a treatment are difficult to buy or make, and in many cases, components of a process are rare and exist in very small quantities. Finally, such a process is difficult…