Today, many producers of biological products are moving towards the use of disposable equipment and devices. In previous methods, the production of recombinant proteins by bacteria, yeasts and animal cells in commercial quantities was done by expensive equipment that was washed and sterilized many times. In order to produce in accordance with GMP principles, it is necessary to comply with certain requirements in order to prevent cross-contamination. In all stages, many instructions are compiled to perform the work, to ensure the correctness of the operations and to control the work steps, which increases the work costs, personnel training and spends a lot of time. The main concern of working with fermentor is the problem of contamination with non-target microorganisms and also cross-contamination. Even though measures have been taken to prevent the occurrence of pollution, which is often difficult and sometimes even with all care, pollution still causes a waste of capital.
In the new generation bioreactors, there is no need for washing and sterilization, and even the sensors are provided as disposable. This technology reduces the downtime of the equipment between two batches, because only the cultivation bag will be replaced. While in steel stirred reactors, the interval between two batches is 8 to 10 hours, and in case of changing the production line to another product, it takes up to 3 weeks. In short, it can be said that in Single-Use bioreactor technology, there is no need to prepare the device for the process, and to start the new process, only the culture medium is added in a pre-sterile bag and then it is placed on the device. This process reduces the preparation time, eliminates the steps of washing and sterilization and validates them, the possibility of performing several processes at the same time, etc.
- Cultivation by perfusion method
- Cultivation of adherent cells using microcarriers
- Touch control panel to set parameters or control through computer
- Controlling the internal pressure of the bag to prevent excessive pressure and tearing
- Advanced warning systems to ensure the safety of the cell culture process
- It has a reciprocating movement very suitable for cell culture with the least destructive pressure
- A wide range of different volumes of culture medium can be used in a culture bag
- Accurate disposable sensors for measuring pH and dissolved oxygen in culture medium
- Real-time monitoring of gas inlet and outlet filters, set parameters and rocker speed
- Card reader system to define authorized user accesses
- Defining different user levels to access each part of the device control system
- The ability to connect wirelessly through the Wi-Fi module to the software for remote control and online checking of the status of parameters
- Quick and easy setup
- Low side costs
- Completely closed and secure system
- Reducing injectable water consumption
- The performance and easy installation of the cultivation bag
- Reduce production validation costs
- The culture bag is pre-sterilized and ready
- Reducing the time and amount of manpower
- No need to wash and sterilize tanks and pipes
- Reducing service and maintenance costs and per capita costs
- Greater flexibility between upstream and downstream production processes
In the production of small volume products such as glycoproteins and vaccines, all process steps can be done in these bioreactors. Beta interferon and therapeutic and diagnostic monoclonal antibodies are among the most important domestic products that can be used in their production.
- Proliferation and differentiation of stem cells
- Cultivation of animal, plant and virus cells
- Preparation of inoculum for higher volume bioreactors
- Quick preparation of the product needed to perform clinical tests
- Cultivation of yeast cells and bacteria at the limit of low and medium concentration cultures
- Production of recombinant proteins, monoclonal antibodies and vaccines according to the GMP standard
- Increasing production volume from low volume flasks and culture flasks
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