An Innovative Approach Towards Standardizing Cell Therapy Manufacturing

In this article, Dr. Shikha Mishra, Technical Workflow Lead for Cell and Gene Therapy at Thermo Fisher Scientific, speaks about recent technologies designed specifically for cell therapy manufacturing applications.

Dr. Mishra explains how the cell therapy manufacturing workflow is a complex, multi-step process. It is very labor intensive with several open processes, making it prone to error and contamination. This contributes to a high manufacturing failure rate, which can significantly impact the cost of the therapy. There are a number of steps where things could go wrong, and cell therapy manufacturing is essentially a zero-failure tolerance setting.

Cell therapy manufacturing is a constantly evolving process. Initially developed through adaptation of existing tools and technologies from other workflows, it is abundantly clear that there is a need for specialized tools to support standardization as the field continues to move forward.