Early Process Development Decisions Pay Off for Cell and Gene Therapies

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The number of cell and gene therapies (CGTs) entering clinical development has increased significantly in recent years. However, the surge in clinical activity has not been matched by an increase in production capacity. Cell and gene therapy manufacturing is still a young industry and Biopharma companies are still figuring out what a standard production facility should look like for these novel biotherapeutics.

In order to help make manufacturing more efficient and cost-effective, it is important to consider building for flexibility and multipurpose manufacturing from the outset. This is particularly important in case of early product approval, which can give manufacturers little time to hone their production processes, resulting in expensive large-scale manufacturing and increasing product cost. More and more companies are now relying on contract development and manufacturing organizations (CDMOs) to guide their development process, avoid pitfalls and prevent delays in time to market. CDMOs are rapidly evolving as full-service partners for CGT developers by combining historical expertise from adjacent industries with new tools and capabilities specific to the complexities of CGTs.

As techniques and technologies are advancing so quickly in cell and gene therapy manufacturing, embracing innovation is critical. Most cell therapies still use risky and expensive open, manual processes. The goal is to move towards closed and automated equipment in order to lower manufacturing costs and risk, as well as modernizing to meet regulatory and supply demands. Automating expensive manual steps also has the advantage of removing manual processing variability.

These complex issues surrounding CT development and manufacturing led Cytiva to develop services and solutions that support process development, scaling and automation. These combined offerings help focus efforts on ensuring that manufacturing processes are robust, combining more than 25 years of development and manufacturing experience in bioprocessing.

This collection of articles focuses on the need for making crucial decisions early in process development in order to minimize risk, cost, product variability and time to market.

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