Mastering gene therapy manufacturing with scalable media formats

Gene therapies have emerged as a groundbreaking avenue for life-saving treatments in a diverse spectrum of diseases. Harnessing the full potential of this technology is contingent upon scaling of operations to seamlessly transition toward sustainable commercial manufacture. Identifying the optimal cell culture medium is a critical consideration for developers, but choosing the ideal medium format is an equally important part of the process that could significantly impact scalability. Selecting the most suitable format will support streamlined operations and consistent manufacturing processes.

Liquid versus dry formats: Making the choice

Liquid media is the preferred format for bench-scale processes. It is ready to use and requires minimal preparation steps, making it a practical solution for small-scale gene therapy development. However, certain challenges can present when scaling toward commercial manufacturing. Weight, extensive storage requirements, and comparatively short shelf life render liquid media inefficient for larger operations, introducing financial and logistical complexities that can limit production capacity. Even choosing to outsource manufacturing space can come with substantial additional costs. The addition of supplements to the liquid media also introduces additional steps and complexities. For these reasons, liquid media becomes a challenging format choice for larger, commercial-scale production.

Dry powder media (DPM) formats offer an effective solution for many of these challenges. Costs are reduced, as it demands less warehouse space and has a longer shelf life. However, the trade-off from streamlined supply logistics is the additional rehydration steps DPM must undergo before its use. These steps necessitate in-house labor and could be vulnerable to inconsistencies between batches. Mitigation is possible with robust quality management protocols; these factors should be carefully considered before scaling up using the DPM format.

Granulated media and the way forward

Today, off-the-shelf media are often available in both liquid and DPM formats, so careful and early process development planning can preemptively address many of these challenges. The emergence of the innovative granulated media format leverages the best of both worlds, helping to streamline scale-up processes and boost operational efficiencies. Granulated media bridges the gap between liquid media and DPM, offering the best of both worlds. Reconstituting granulated media is simple, requiring few adjustments and easy supplement integration, reducing the risk of inconsistencies. While boasting similar storage and shipping benefits as DPM, granulated media formats can help reduce operating costs and increase productivity.

Ultimately, to keep up with this advancing industry, early consideration of media format scalability and cost-effectiveness can help optimize development and accelerate the journey to market.

Learn more at https://thermofisher.com/gibco-gene-therapy.