JP2009065843A - Mobile type storage apparatus of cell preparation facility - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a mobile type storage apparatus of a cell preparation facility capable of temporarily evacuating cultured cells or product cells from a bioprocessing facility equipped with a biopreparation work room. <P>SOLUTION: The mobile type storage apparatus comprises a cell preparation storage room installed on a vehicular carriage and equipped with a cleaning means. A storage means capable of housing culture vessels holding processing historical data for cells cultured and processed in the bioprocessing facility is built in the cell preparation storage room. A storage control means for controlling the atmospheric environment in the storage means is provided and designed to read the processing historical data accompanied with the culture vessels and continuously set the culture environment necessary to the cell culture in the cell storage means. The cultured cells carried in with emergency or temporary evacuation can continuously be cultured by using the same atmospheric environment as that of the culture environment of the bioprocessing facility on the basis of the read data. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

  The present invention relates to a mobile storage device in a cell preparation facility, and in particular, a cell culture in a regenerative medical facility, a biohazard countermeasure room, or a facility having a biopreparation work room such as a gene manipulation room has a natural disaster or accident such as an earthquake. The present invention relates to a mobile storage device of a cell preparation facility used for urgent evacuation of cells in culture due to the occurrence of an emergency such as.

  In recent therapeutic medicine, research on regenerative medicine in which cells collected from a living body are cultured to regenerate a lost living tissue has been actively conducted. In such regenerative medicine, cells collected from a patient are often prepared by washing, concentrating, culturing, etc. using CPF (Cell Processing Facilities), and the prepared product is returned to the same patient to treat the patient. The patient being treated for illness is in a state where a product derived from autologous cells to be shipped from CPF is completed and is waiting for administration or transplantation. It is necessary to operate and manage the CPF so that such a product must not be lost due to defects in the production process of the CPF, resulting in a defective product that cannot be returned to the patient.

  In general, CPF is equipped with a CPF device such as a safety cabinet, a clean bench, and an isolator installed in a bioclean room (BCR) in order to prepare cells aseptically. Equipment such as a liquid nitrogen storage container and an ultra-low temperature tank for freezing and storing finished products is provided. Further, there are refrigerators and freezer CPF devices for storing reagents and raw materials.

A general CPF has a configuration as shown in FIG. There are a plurality of working chambers 1 (1a, 1b,...) For cell culture and the like according to the work contents. The work room 1 is configured as a BCR, and each work unit includes a work room 1, a dressing room 2, and a dressing room 3 as work units. After wearing sterile clothes in the clothing room 2 which is the front room of the work room 1, the work room is entered and the work is executed. After the work is finished, the user enters the undressing room 3 which is the rear room, and removes the sterile clothes and goes outside. There is a management corridor 4 common to each work unit, and it is possible to enter and leave the building outside through the front room 5 at the entrance of the building. The work room 1, the dressing room 2, the dressing room 3, the management corridor 4, and the front room 5 have independent air supply systems and exhaust systems, respectively. The specified room pressure is maintained. In addition, the working environment is created so that the internal environment of the safety cabinet installed in each working room 1 is usually an atmospheric condition determined for each culture condition and inspection condition. The finished product cells are stored in the cryopreservation chamber 6 or the like so as to be in a predetermined atmospheric condition. There exists patent document 1 as this related technology.
Japanese Patent Laid-Open No. 2004-119

  By the way, in such a CPF, preventive maintenance is performed in order to constantly maintain the performance of CPF including BCR and the performance of these CPF devices and maintain the safety and effectiveness of the quality of manufactured products. Is called. Preventive maintenance is an action to maintain the reliability of repairable systems, equipment, parts, etc. In CPF, as a preventive maintenance or maintenance inspection, it is planned to inspect, test and readjust according to a predetermined procedure. To prevent malfunctions during use. And during preventive maintenance, the quality of products in production and the quality of production during storage must be maintained. Therefore, for preventive maintenance, there has been a problem that a maintenance plan must be made and maintenance must be performed by temporarily stopping the operation of the CPF air conditioning system and CPF equipment.

  In addition to the preventive maintenance work as described above, the sudden failure of the air conditioning system may cause the CPF performance to deteriorate until the product cannot be manufactured continuously. May not be able to continue manufacturing. In addition, if the air supply / exhaust system in the work room is damaged due to a disaster or accident such as an earthquake, or if the work room wall is damaged, the cell culture environment cannot be maintained, and the finished product cells will be damaged. . For this reason, although it is necessary to evacuate urgently, if cells are taken out from the safety cabinet or the culture vessel is taken out, the previous culture environment cannot be maintained, and the function as a living cell may be lost. There is.

In these cases, if there is a storage environment in which the cells and products are not contaminated with dust and microorganisms and the quality can be maintained, it is possible to avoid the death and disposal of the CPF cells and products. In addition, if there is a facility that can handle storage near CPF, cells and products can be temporarily evacuated and stored, so that valuable cells and products do not need to be killed.
Such a problem also applies to a facility having other biopreparation work rooms such as a biohazard countermeasure room and a gene operation room.

  The present invention pays attention to the above-mentioned conventional problems, periodic maintenance work of a bioprocessing facility equipped with a biopreparation work room such as a cell culture / preparation room, a biohazard countermeasure room, a gene operation room, etc. It is an object of the present invention to provide a mobile storage device of a cell preparation facility that can temporarily evacuate cells in culture and product cells in the event of a sudden accident such as an earthquake or a natural disaster such as an earthquake.

  In addition, CPF air-conditioning and equipment performance can prevent the product from being produced continuously and can be produced continuously, maintaining the quality without contaminating CPF cells and products with microorganisms. It is an object of the present invention to provide a mobile storage device for a cell preparation facility capable of creating such a conservation environment.

  In order to achieve the above object, a mobile storage device for a cell preparation facility according to the present invention has a cell preparation storage chamber installed on a vehicle carriage and provided with a cleaning means, and the cell preparation storage chamber includes a bioprocessing facility. Incorporates a storage means that can accommodate a culture vessel that holds the processing history data of the cells that have been cultured in step 1. The processing history data that accompanies the culture vessel is read to perform the culture required for cell culture Equipped with storage management means for continuously setting the environment in the cell storage means, and reading the cultured cells brought in by emergency or temporary evacuation as the same atmosphere environment as the culture environment of the bioprocessing facility based on the read data It is characterized by enabling continuous culture.

  The present invention also provides a power supply vehicle in which a mechanical vibration generating device such as a generator or an air conditioner is mounted on a vehicle carriage, and a cell equipped with a cell preparation and storage function on the vehicle carriage based on the power provided from the power supply vehicle. The cell preparation storage vehicle includes a cell preparation storage chamber equipped with a cleaning means, and the cell preparation storage chamber includes a cell processing history of cells cultured in a bioprocessing facility. The storage means that can accommodate the culture vessel that holds the data is built-in, and has storage management means for managing the atmospheric environment in the storage means, and reads the processing history data attached to the culture vessel. Storage management means for continuously setting the culture environment necessary for cell culture in the cell storage means, and reading the cultured cells brought in by emergency or temporary evacuation to the cell storage vehicle. It is characterized in that to be able to continue the culture as the same ambient environment and culture environment of biotreatment facilities on the basis of the taken data.

  The vehicle carriage has a product storage chamber capable of accommodating a container storing product cells, and the storage management means can set the product storage chamber as a storage environment for the product storage container.

In addition, CPF equipment that stores cells in a frozen state, such as a liquid nitrogen storage container, a CO ₂ culture container that cultivates cells, and a safety cabinet that can be aseptically operated, maintain cleanliness that can ensure the quality of raw materials and products. To create a sustainable environment.

The safety cabinet installed in the vehicle can be installed assuming that it is necessary to perform aseptic operation when culturing is temporarily continued. It is also possible to provide a function for keeping a record of manufacturing management status.

  Therefore, the mobile storage apparatus can constitute a temporary storage system for cells, etc., and has a system having a contamination prevention function for transporting cells to a temporary storage destination, and / or a temporary contamination prevention function. It can be constructed as a cell storage system. Alternatively, based on the contract between the CPF owner (A person) and the emergency vehicle provider (B person), the B person provides the emergency vehicle at the request of the A person. It can be constructed as a system that can verify and confirm by a test that a product can be temporarily stored in advance.

  In CPF, since the production method and storage method of the cells are different for each product, if person A uses the vehicle to verify the product storage method and cell storage method of the temporary cell storage vehicle, Good. If the system is aseptically transporting cells to a temporary storage location, or if it is planned to be transported in advance, it has the function of being transported aseptically. What is necessary is just to arrange | position and arrange the box for transfer assumed temporarily taking out or emergency taking out.

  In the mobile storage device of the cell preparation facility according to the present invention, data is attached to a mobile body such as a culture vessel temporarily or during emergency evacuation using the data recording means of the mobile culture environment and moved to an emergency vehicle. In the emergency vehicle, the data is read, and the storage management means is driven based on the read data so that the culture environment becomes the same environment as the facility. As a result, the temperature and humidity and the gas environment are the same as the conventional biopreparation work room, and the culture environment is continued. As a result, a continuous culture environment can be realized in a moving vehicle, and transportation to a safe area is facilitated.

  Mobile vehicles can also be divided into power supply vehicles (EP vehicles) equipped with a generator and air conditioning equipment, and cell storage vehicles (CP vehicles) that mainly store cells. By separating the EP vehicle and the CP vehicle, the influence on the cell culture due to the vibration and sound of the generator can be avoided, and the culture environment of the facility can be approached.

A specific embodiment of a mobile storage device of a cell preparation facility according to the present invention will be described in detail with reference to the drawings.
Drawing 1 is a plane lineblock diagram which looked at a mobile storage device of a cell preparation facility concerning an embodiment from the upper part. As shown in this figure, the mobile storage device according to the embodiment has a moving vehicle 10 and is mounted and installed in a cargo compartment provided in a loading platform 12 of the truck vehicle. The truck bed 12 is formed by a body frame formed directly on a tow truck or a moving body as a chassis.

  Such a truck carrier 12 is provided with a cargo compartment 14, and a clean cell preparation storage chamber 16 is formed in the cargo compartment 14. The cell preparation storage chamber 16 is equipped with a plurality of storage containers 20 that can accommodate culture containers 18 such as flasks, dishes, bags, etc. that are used for culture processing in bioprocessing facilities. Further, a product storage chamber 22 is provided adjacent to the cell preparation storage chamber 16 so that a storage container 24 for regenerated cells completed as a product can be accommodated therein. A storage control device 26 that performs overall control related to air conditioning and a storage management device 28 that handles history data of the culture vessel 18 and the storage vessel 20 are provided.

  First, each culture vessel 18 is provided with a collation recording means (not shown) such as an IC tag. The collation recording means includes specific data of cultured cells and culture environment data in the bioprocessing facility. The culture environment is recorded, and the culture environment immediately before the culture vessel 18 can be extracted by reading the collation recording means. This recorded data may be stored in the memory of the IC tag itself, or may be stored in an external management recording means so that it can be detected by collation with an IC number.

  In the cell preparation storage chamber 16, when the culture container 18 is accommodated in the storage container 20, a data reader 30 that can read the processing history data of the cultured cells from the reference recording means attached to the culture container 18. Equipped. The data reader 30 reads the processing history data attached to the culture vessel 18 and transmits the processing history data to the storage management device 28 also provided in the loading platform 12.

  The storage control device 26 controls the air conditioning system devices of the cell preparation storage chamber 16 and the product storage chamber 22 and controls them. The storage control device 26 controls the temperature, humidity, cleanliness, and room pressure of the cell preparation storage chamber 16 at the same time.

On the other hand, the storage management device 28 takes in all the reading data of the culture container 18 to manage the history of a plurality of cell preparation storage chambers 16 and identify the storage container 20 set with the cell preparation storage chamber 16 (storage container number, etc.). ) Management. In the storage management device 28, information (temperature, humidity, CO ₂ concentration, etc.) of the culture vessel 18 is monitored, recorded and managed. In addition, the storage management device 28 manages (1) what time, (2) which storage container 20 the individual culture container 18 is set in, and (3) manages the operation record of the storage container 20 during the use period, and cultures it from the vehicle. When the container 18 is returned to the facility, it is proved by the record data of the storage management device 28 that the container 18 has been properly stored for the period of time in which the container 18 is deposited.

  The air conditioning equipment is not affected by the history information of the culture vessel 18 and is managed by the storage control device 26 at a constant level. For example, the temperature and humidity in the cell preparation storage chamber 16 are 22 ° C. and 60% RH or less, and are controlled and controlled such as an appropriate number of ventilations (for example, 30 ventilations / hour).

Further, the storage container 20 has a control function for each storage container 20, and controls the culture environment (culture atmosphere gas) of the culture container 18 to, for example, 37 ° C., a CO ₂ concentration of 5%, and a humidity of 96% or more. Is done. A plurality of culture containers 18 can be set in the storage container 20.

  The mobile storage device of the cell preparation facility as described above receives the culture container 18 and the product storage container 24 that are withdrawn from the bioprocessing facility due to preventive maintenance, equipment / equipment failure, or natural disaster. At this time, when the culture vessel 18 is put into the cell preparation storage room 16, the culture environment data in which the culture vessel 18 has been placed so far is read by the data reader 30, and the storage management device in which all the read data of the culture vessel 18 is taken in. 28 controls the history management of the plurality of cell preparation storage chambers 16 and the management of the identification (storage container number, etc.) of the storage containers 20 set with the cell preparation storage chambers 16. As a result, the culture atmosphere gas in the storage container 20 is prepared so that the culture environment of the bioprocessing facility and the internal environment of the storage container 20 as the retreat destination are the same. On the other hand, when returning to the facility side, the record data of the storage management device 28 indicates that the individual culture container 18 has managed the operation record of the storage container 20 during the period of use and has been properly stored for the period left in the vehicle. Prove with.

  On the other hand, the storage control device 26 manages the internal environment of the cell preparation storage chamber 16 so that it is separated from the history information of the culture vessel 18 and has a predetermined temperature, humidity, and ventilation frequency.

As described above, according to the mobile storage device of the cell preparation facility according to the present embodiment, the storage management device 28 performs the culture environment in the storage container 20 and the culture container 18 accommodated in the facility so far. The air conditioning equipment is adjusted to adjust the temperature and humidity conditions and the CO ₂ gas environment is adjusted so that the culture history can be continuously implemented. For this reason, although not shown, it is equipped with air conditioning means for making the cell preparation storage chamber 16 into a clean room, means for adjusting temperature and humidity for each storage container 20, and culture atmosphere gas adjusting means.

  With this configuration, it is possible to read the processing history data attached to the culture vessel 18 and continuously set the culture environment necessary for cell culture in the cell storage vessel 20, and temporarily save it. Based on the read data, the cultured cells carried in can be continuously cultured in the same atmosphere environment as the culture environment of the bioprocessing facility.

  Further, in the loading chamber 14 of the mobile vehicle 10 of the mobile storage device according to this embodiment, the product storage that can accommodate the product storage container 24 that has already been cultured in the bioprocessing facility and stored as product cells. A chamber 22 is provided. Since the product storage container 24 is normally stored frozen, it may be set in advance to the refrigeration management temperature managed in the facility. Of course, an IC tag may be attached to each product storage container 24, and the tag data may be read by the storage management device 28, and the management temperature may be set based on the read data.

  The mobile vehicle 10 of the mobile storage device configured as described above is dispatched when the bioprocessing facility is primarily evacuated for preventive maintenance or due to equipment / equipment failure, earthquake, etc. Together with the product storage container 24, the culture container 18 in which cells currently being cultured are stored is unloaded and stored. The culture history data up to that time is attached to the culture vessel 18 by a verification recording means such as an IC tag, and the data reader 30 reads the data and transmits it to the storage management device 28.

  The storage management device 28 that has received the data acquires culture environment data such as temperature, humidity, and environmental atmosphere gas concentration for each storage container 20 that has read the culture environment, and sets the internal environment of the storage container 20 immediately before the accommodating culture container 18. It can be adjusted to be the same as the environmental conditions. Thereby, it can culture | cultivate continuously in an emergency storage vehicle as the same atmospheric environment as the culture environment of a bioprocessing facility. The product storage container 26 is also properly stored in the product storage chamber 22 in the same environment. The vehicle can then be moved to a safe area and relocated to an unaffected bioprocessing facility. In addition, when the positional evacuation is completed and returned to the facility, it can be proved by the record data of the storage management device 28 that the storage is properly performed for the period of time in which the vehicle is stored.

  FIG. 2 shows the configuration of the mobile storage device of the cell preparation facility according to the second embodiment. This is an electric power supply vehicle (EP vehicle) 10A equipped with mechanical vibration generators such as a generator 32 and an air conditioner 34, and a cell storage vehicle (CP) that performs cell storage based on the electric power provided from the electric power supply vehicle 10A. Vehicle) 10B.

  The cell storage vehicle 10B is provided with a cell preparation storage chamber 16 equipped with a cleaning means, and the cell preparation storage chamber 16 accommodates a culture vessel 18 holding cell processing history data in a bioprocessing facility. A possible storage container (storage means) 20 is provided, and a storage management device 28 for managing the atmospheric environment in the storage container 20 is provided. The processing history data attached to the culture vessel 18 is read, and the culture environment necessary for cell culture is continuously set in the cell storage vessel 20.

  In the example shown in the figure, the power providing vehicle (EP vehicle) 10A and the cell storage vehicle 10B are configured as independent moving vehicles. However, any one of them may be configured as a towing vehicle.

  As described above, in the second embodiment, the devices that serve as the vibration source are concentrated on the EP vehicle 10A side, and the vibration and sound are separated so as not to affect the cell culture. This makes it possible to bring the cell culture closer to the culture environment in the facility even in the temporarily retracted state.

It is a plane lineblock diagram of a mobile vehicle concerning a 1st embodiment of a mobile storage device concerning the present invention. It is a plane block diagram of the moving vehicle which concerns on the 2nd Embodiment. It is a layout diagram of a bioprocessing facility.

Explanation of symbols

  10 ......... Moving vehicle, 12 ......... Truck loading platform, 14 ......... Loading room, 16 ......... Cell preparation storage room, 18 ......... Culture container, 20 ...... Storage container, 22 ......... Product preservation Room 24... Product storage container 26... Storage control device 28... Storage management device 30... Data reader 32.

Claims (3)

A cell preparation storage room installed in a vehicle carriage and equipped with a cleaning means;
This cell preparation storage room has a built-in storage means that can accommodate a culture vessel that holds processing history data of cells that have been cultured in a bioprocessing facility,
Equipped with storage management means for reading the processing history data attached to the culture vessel and continuously setting the culture environment necessary for cell culture in the storage means,
A mobile storage device for a cell preparation facility, wherein the cultured cells brought in by emergency or temporary evacuation can be continuously cultured in the same atmosphere environment as the culture environment of the bioprocessing facility based on the read data. A power supply vehicle equipped with mechanical vibration generators such as generators and air conditioners;
The cell storage vehicle is configured to store cells based on the power provided from the power supply vehicle, and the cell storage vehicle has a cell preparation storage room equipped with a cleaning means,
The cell preparation storage room has a built-in storage means capable of accommodating a culture vessel that holds processing history data of cells that have been cultured in a bioprocessing facility,
Equipped with storage management means for reading the processing history data attached to the culture vessel and continuously setting the culture environment necessary for cell culture in the storage means,
A cell preparation facility characterized in that the cultured cells brought in by emergency or temporary evacuation to the cell storage vehicle can be continuously cultured in the same atmosphere environment as the culture environment of the bioprocessing facility based on the read data Mobile storage device. The vehicle carriage has a product storage room capable of storing a container storing product cells, and the storage management means can set the product storage room as a storage environment of the product storage container. The mobile storage device for a cell preparation facility according to claim 1 or 2.

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