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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 to develop accelerated review pathways. Consistent, safe and cost-efficient manufacturing of cell and gene therapies has been identified as a key challenge in many talks and publications by regulators. The shortened development timelines as a result of accelerated pathways have added to the challenges associated with CGT manufacture.

For the purpose of this paper, we will focus on raw materials and not on starting materials.