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 to scale up because current manufacturing processes may not be not amenable to scale up.

Additional challenges can be found early in the development stage, including selecting the right combination of host/virus systems. Selecting the right combination will depend mainly on safety, toxicity, and the ability of a host/virus combination to effectively produce a target product.

At Fujifilm Diosynth Biotechnologies, process and analytical development, technical evaluation, selection, and ordering of process equipment and materials are assessed based on each individual process.

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