Cell therapy has emerged as a promising new treatment in medicine, which is expected to be able to cure diseases by repairing, replacing, and regenerating tissues, as well as through immune modulation. However, challenges remain in ensuring consistent quality, clinical efficacy, and safety profiles because of the diversity of cell types and clinical indications for cell therapy products (CTPs), as well as different and complex manufacturing process. Therefore, scientific consensus and regulatory measurements are urgently warranted to promote the translation of the latest scientific advances and innovative manufacturing technologies into clinical application. This article aims to propose perspectives on the manufacturing, quality study, and quality control of CTPs and provide considerations and opinions in the regulation of CTPs.
Keywords: cell therapy products; clinical application; manufacturing; process development; quality control; regulation.