Establishment of a commercial manufacturing facility for CAR-T product with small IT system in an academic organization

Abstract

Background & Aim The cellular and gene therapy (CGT) is at the cutting edge of innovation and offer a major hope for unmet medical needs. At 2019 more than 1000 clinical trials are ongoing in the world and approximately 900 companies, ventures, medical institute and research organizations are committed to the cellular and gene therapy field. But the commercialization of the CGT with large scale manufacturing is still challenging because of many difficulties caused by the nature of the cellular product. To accelelate the introduction of cell therapy, we analyzed the obstacles for commercialization and propose the introduction of the small IT system for the scale up of the cell prduct manufacturing site. Methods, Results & Conclusion High manufacturing cost caused by expensive materials, high FTE, low productivity high and construction / maintenance cost of manufacturing facilities. To overcome these difficulties we have introduced IT system in chain of identities, materials control and manufacturing scheduling without the introduction of large PAS system which is usually used in a big pharma but requires very high cost. We present the results of our experience of introduction of small IT system in establishment of large scale manufacturing on a cell therapy product. The cellular and gene therapy (CGT) is at the cutting edge of innovation and offer a major hope for unmet medical needs. At 2019 more than 1000 clinical trials are ongoing in the world and approximately 900 companies, ventures, medical institute and research organizations are committed to the cellular and gene therapy field. But the commercialization of the CGT with large scale manufacturing is still challenging because of many difficulties caused by the nature of the cellular product. To accelelate the introduction of cell therapy, we analyzed the obstacles for commercialization and propose the introduction of the small IT system for the scale up of the cell prduct manufacturing site. High manufacturing cost caused by expensive materials, high FTE, low productivity high and construction / maintenance cost of manufacturing facilities. To overcome these difficulties we have introduced IT system in chain of identities, materials control and manufacturing scheduling without the introduction of large PAS system which is usually used in a big pharma but requires very high cost.