Materials derived from human blood such as human serum albumin and transferrin are frequently used either as components of cell culture medium or in other processes. Suppliers of such reagents have incorporated multiple mitigation steps such as sourcing pharmaceutical grade or licensed drug product, sourcing from safe geographical regions, testing for contaminants and inactivation. In addition, this information needs to be available for review during inspections and in regulatory filings. This questionnaire is a comprehensive list of those requirements and will be a useful document for reference.
Rx-360 Guidance and Best Practices for Raw Material Supply Chain Security for Cell and Gene Therapies
Cell and gene therapies (CGT) are novel therapeutic modalities with greater than one thousand clinical trials ongoing globally. The unmet need for treatment options and the promise of these therapies has prompted regulatory agencies world-wide […]