Consumables needed for WAVE disposable reactor: including cell bags, liquid storage bags, hoses, filters and tangential flow membranes, etc., usually made of medical grade plastic materials (such as polyethylene, polycarbonate, polystyrene, etc.) , sterilized by gamma rays in advance can effectively prevent pollution and realize ready-to-use. Compared with traditional stainless steel reactors, this method reduces the sterilization process and the dependence on other public facilities (such as water systems and steam, etc.) , saving plant construction and construction costs, reducing the difficulty of plant construction, and significantly reducing production cost input.
The use of consumables such as disposable reactors can also reduce the company's training costs for employees, such as training on the use of public facilities, cleaning and sterilization, and subsequent verification, reducing employee operating errors and shortening the drug production cycle. The WAVE disposable bioreactor also reduces the possibility of cells being exposed to the external environment of the laboratory multiple times during the culture period. Sterile disposable tubing and transfer bags are used in the inoculation, feeding, sampling and transfer processes. To a great extent, it meets the requirements of GMP production for a closed environment, and shortens the time to market of pharmaceutical products while complying with regulations.
Advantages and disadvantages of single-use bioreactors
1. Reduce the difficulty of process certification and eliminate the need for cleaning certification.
2. Reduced downtime and turnaround time: as an example, product changeover time also depends on the manufacturing mode, a 2-hour changeover time using a single-use bioreactor (including the time required to make all connections) would be equivalent to a stainless steel bioreactor for the same product 6-10 hours switching time. If it is a different product conversion, the latter will take about 3 weeks. For the different products in the hybrid system (a combination of single-use equipment for upstream production and a combination of stainless steel systems for downstream purification), the switchover time was approximately two weeks. If the single-use bioreactors in the line are connected to single-use filters and bags using single-use sterile connectors, a complete product changeover will take no more than 48 hours.
3. Significantly controls the possibility of batch-to-batch contamination from unscheduled microbial or product cross-contamination.
4. Reduce operating costs and capital investment, save space and labor requirements.
5. Eliminate design elements of traditional stainless steel vessels specified by CIP and SIP requirements.
6. Easy to install. Move easily when you're free.
1. Volume scalability is a problem: The market is currently unable to meet the needs of large-scale bioreactors above 2,000 liters.
2. In the wave-type disposable bioreactor, the motion principle of unconventional rocking motion limits the use of this culture bag, and there are fewer controllable parameters.
The oxygen transfer coefficient (kLa) in the existing single-use bioreactor is low, so it is only suitable for mammalian cell culture, not suitable for the upstream production of bacteria or yeast with greater oxygen demand.
3. Inability to store hotter liquids to prevent problems with leachable and extractable materials.
4. Disposable bags are at risk of being punctured.
5. Garbage disposal costs increase.