FUJIFILM Irvine Scientific Contributes to Critical Materials Management in Cell Therapies

January 21, 2021

FUJIFILM Irvine Scientific recently contributed to an ISCT Process and Product Development (PPD) Committee white paper, Transitioning from development to commercial: risk-based guidance for critical materials management in cell therapies. Published in the journal Cytotherapy, the article provides a practical risk assessment approach for raw materials to help cell and gene therapy manufacturers and suppliers actively assess materials early in development. This approach can be utilized as a starting point for risk mitigation during the translation of cell and gene therapy products for clinical and long-term commercial application.

The article's panel also discusses how to address non-obvious risk mitigation challenges such as rapid growth in the cell and gene therapy space, individual product and process complexity, and limited industry-specific guidance. Key examples presented include a risk-based approach that highlights patient safety concerns to help manufacturers focus and coordinate efforts to address critical risk factors such as primary starting material, culture media, reagents, and single-use components. A hypothetical gene-edited cell therapy is also used as an example of sample risk assessment methodology applied to the general manufacturing process.

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