Macroscopic Consideration on Procurement of Equipment
Prior to the design of manufacturing layout in the process of industrialization, constructs of a well-established system related to the types of equipment procured are taken into considerations:
■ Cost
Cells for clinical use must be prepared and stored in a cleanroom kept in a state of very high cleanliness. The cost for maintaining the required level of cleanliness, however, is extremely high. The preparation of cells is therefore very costly, and this has been a great hindrance against industrialization.
■ Quality
The series of operations from establishment of cells to their storage are complex, and many of them must be carried out by hand. Moreover, the preparation of cells often depends on a personal level of skill. Therefore, the quality of cells varies depending on the preparer and on the particular experimental batch.
■ Time
In order to prevent cross-contamination with cells other than those of a particular donor in the cleanroom, cells from only a single individual shall be prepared in the same cleanroom over a prescribed period of time. In addition, long time periods are necessary to establish cells and evaluate their quality. However, since cells are only prepared once for a single individual in the cleanroom, a very long period of time is required to prepare cells for many different individuals.
■ Personnel
As mentioned above, currently the preparation of cells is for a large part carried out by hand. Nevertheless, few technicians have the skills necessary for them to prepare cells for clinical use.
It is a problem that the series of operations from establishment of cells to their storage are complex. To counter this problem, it is an object of the equipment procured for providing a cell production system that allows successful production of cells.
According to one aspect of a well-established ambient for manufacturing, a cell production system comprising a pre-introduction cell solution-feeding channel through which a cell-containing solution passes, a factor introducing device connected to the pre-introduction cell solution-feeding channel, that introduces potency inducing factors into cells to prepare inducing factor-introduced cells, a cell mass preparation device that cultures the inducing factor-introduced cells to prepare a plurality of cell masses comprising stem cells, and an enclosure that houses the pre-introduction cell solution-feeding channel, inducing factor solution-feeding mechanism, factor introducing device and cell mass preparation device, wherein the cell mass preparation device comprises an initializing culturing apparatus that cultures the inducing factor-introduced cells that have been prepared by the factor introducing device, and an amplifying culturing apparatus that carries out amplifying culturing of the plurality of cell masses comprising stem cells that have been established by the initializing culturing apparatus, the initializing culturing apparatus comprises a first culture medium supply device that supplies culture medium to the inducing factor-introduced cells, and the amplifying culturing apparatus comprises a second culture medium supply device that supplies culture medium to the plurality of cell masses.
■ Cost
Cells for clinical use must be prepared and stored in a cleanroom kept in a state of very high cleanliness. The cost for maintaining the required level of cleanliness, however, is extremely high. The preparation of cells is therefore very costly, and this has been a great hindrance against industrialization.
■ Quality
The series of operations from establishment of cells to their storage are complex, and many of them must be carried out by hand. Moreover, the preparation of cells often depends on a personal level of skill. Therefore, the quality of cells varies depending on the preparer and on the particular experimental batch.
■ Time
In order to prevent cross-contamination with cells other than those of a particular donor in the cleanroom, cells from only a single individual shall be prepared in the same cleanroom over a prescribed period of time. In addition, long time periods are necessary to establish cells and evaluate their quality. However, since cells are only prepared once for a single individual in the cleanroom, a very long period of time is required to prepare cells for many different individuals.
■ Personnel
As mentioned above, currently the preparation of cells is for a large part carried out by hand. Nevertheless, few technicians have the skills necessary for them to prepare cells for clinical use.
It is a problem that the series of operations from establishment of cells to their storage are complex. To counter this problem, it is an object of the equipment procured for providing a cell production system that allows successful production of cells.
According to one aspect of a well-established ambient for manufacturing, a cell production system comprising a pre-introduction cell solution-feeding channel through which a cell-containing solution passes, a factor introducing device connected to the pre-introduction cell solution-feeding channel, that introduces potency inducing factors into cells to prepare inducing factor-introduced cells, a cell mass preparation device that cultures the inducing factor-introduced cells to prepare a plurality of cell masses comprising stem cells, and an enclosure that houses the pre-introduction cell solution-feeding channel, inducing factor solution-feeding mechanism, factor introducing device and cell mass preparation device, wherein the cell mass preparation device comprises an initializing culturing apparatus that cultures the inducing factor-introduced cells that have been prepared by the factor introducing device, and an amplifying culturing apparatus that carries out amplifying culturing of the plurality of cell masses comprising stem cells that have been established by the initializing culturing apparatus, the initializing culturing apparatus comprises a first culture medium supply device that supplies culture medium to the inducing factor-introduced cells, and the amplifying culturing apparatus comprises a second culture medium supply device that supplies culture medium to the plurality of cell masses.
Microscopic Consideration on the Enhancement of Cell Production
When manufacturing cell products, we require variety of research tools for cell sorting, cell culture, expansion, differentiation and cytometric analysis. Nevertheless, various of equipment are needed in different stages of the production line based on the types of cell technology implementations. Since the development of the immune cells and stem cells are dissimilar in sample collection, equipment used are obviously different in large in the early stage of preparation. Interestingly, cell analysis may be in common in the final analytic step. Thus, the infrastructure is much easier to be established in the rear-end production.
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