1. Field of the Invention
The present invention relates to a culture chamber for culturing cells, cellular aggregates, particles, tissues and organoids. More particularly, the present invention relates to a culture chamber having one or more molecular weight cut-off membranes transversing the chamber, wherein incoming media enters the chamber through an inlet and then passes through a membrane into the culture chamber and the exiting media passes through the membrane and then out the chamber outlet.
2. Description of the Related Art
The biomanufacturing industry is experiencing rapid growth. One aspect of that growth is that the demand for the production of new therapeutic protein products is greatly exceeding capacity. To keep pace with the drugs and antibodies generated in cell culture that are coming to market, biomanufacturing industry requirements for therapeutic protein production is expected to increase yet another five or six fold over the next couple of years. Since the industry is already exceeding current capacity for the production of therapeutic proteins, new processes and apparatuses are needed that are more efficient and that can be scaled up for the production of larger quantities of therapeutic proteins.
One of the major problems in producing therapeutic protein products is the time and costs of purifying the desired protein from the cell media. It is estimated that two thirds of the time and costs of manufacturing proteins from cell cultures is related to the separation of the desired protein product from the waste products. Thus, there is a need to produce a more concentrated protein product upstream to reduce the downstream processing required to purify the protein product.
In addition, the expense of producing biologicals in aseptic bioreactors is exacerbated by the required cleaning, sterilization and validation of the standard stainless steel or glass bioreactors by the customer. There is a continuing need to develop lightweight, presterilized, disposable culture chambers with simple connections to existing equipment that require little training to operate, yet provide the necessary gas transfer and nutrient mixing required for successful cell cultures. If the culture chambers used in producing therapeutic proteins could be made disposable, a reduction in the risk of cross contamination, the time and expense in changing from the production of one protein to another, and the downtime needed for equipment changeover between production runs would be realized.