The Role of Analytics in Cell and Gene Therapy Reproducibility and Regulatory Approval

In light of recent highly publicized late-stage review issues in the cell and gene therapy field, the need for reliable analytics tools has become clear. The lack of purpose-built bioprocessing technologies has left many cell and gene therapy manufacturers relying on outdated monoclonal antibody technologies that have seen little evolution over the years.

Notably, many of these cases were linked to potency assay issues, prompting questions about whether such setbacks could have been prevented through the application of advanced analytics to thoroughly characterize products.

In partnership with Phacilitate, this report delves into pivotal role of analytics in the cell and gene therapy landscape, focusing on:

• Defining critical quality attributes effectively
• Identifying the necessary measurements for successful regulatory submissions
• Understanding how robust analytics contribute to reproducibility and streamlined regulatory filings
• Designing the optimal, scaled analytics model to meet the demands of the industry