Upholding raw material suppliers to higher quality standards to better support cell and gene therapy manufacturers

Health authority guidance recommends that all raw materials intended for use in the production and distribution of a cell and gene therapy (CGT) product be carefully selected and appropriately qualified. As part of this process, CGT manufacturers thoroughly evaluate the quality of materials to identify any potential risks to patient safety, process execution, product quality, and material management. This evaluation relies heavily on the review of supplier documentation, such as product descriptions, certificates of analyses (COA), certificates of origin (COO), and quality questionnaires. Currently, there is no standardization for the manufacture and characterization of raw materials, and the availability and details on each of these documents are at the discretion of the supplier. When limited information is available, it becomes the responsibility of the CGT manufacturer to work in cooperation with each supplier to seek, review, and audit their processing procedures and documentation to appropriately qualify the suitability of a material. Raw material suppliers can better support the CGT industry by committing to the highest possible quality standards in the manufacture, testing, and associated documentation for materials intended for CGT manufacture. This would provide a great service to the industry as a whole, because as more suppliers offer raw materials aligned with CMC guidelines and quality standards, the more CGT manufacturers can develop and deliver compliant products quickly, reliably, and safely to more patients.

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