MDI AseptiWave pre-sterilized and disposable bioreactors are designed for efficient cell culture of all cell types including Mammalian cells, Plant cells, Insect cells, Microbial cells, Stem cells, etc.
These are available gamma sterilized, in multiple sizes ranging from 2 liters for clone selection and media optimization labs, up to 50 liters for process development as well as GMP production of biopharmaceuticals.
The bag is placed on any wave inducing rocker base unit/bioreactor system that induces the waves in the cell culture fluid inside the bag through the rocking motion to provide efficient mixing and gas transfer.
These bags are ideal for the culture of shear sensitive cell lines and can be customized to meet user requirements to eliminate the risk of cross contamination and ease operations. AseptiWave Bioreactors are also available with an optical pH Sensor and DO Sensor for high accuracy and optimal process control embedded on the bag.
Expansion of anchorage dependent cells such as epidermal and connective tissue cells
The growing trend towards incorporation of single use technologies into bioprocesses as an alternative to reusable systems have paved the way for many single use components and systems as these provide increased manufacturing flexibility.
Bioprocess operations such as cell-culture and mixing involve disposable systems which require real time monitoring to determine whether various critical process parameters (CPPs) such as pH, conductivity, dissolved oxygen, etc are maintained within specifications.
To measure CPPs, different types of on-line sensors are used. On-line sensors interface directly with Bioreactor/Mixer and are in contact with contents in it. Such systems are also available with pre installed single use sensors. However, these disposable sensors have multiple challenges in terms of accuracy, reliability, on site calibration, etc.
These disposable sensors also reduce the overall residual shelf life of high value Single Use Mixers/ Bioreactors, making reusable sensors the preferred choice. The reusable sensors can be calibrated and autoclaved before use.
MDI AseptiProbe Bellow Assembly is designed to address the need to aseptically connect reusable sensors to single use bioreactors or mixers. These assemblies enable real-time monitoring while eliminating laborious cleaning validation requirements, reducing the risk of cross-contamination, and improving sterility assurance. These Bellow Assemblies are validated to prevent microbial ingress and are 100 % integrity tested.
Aseptiprobe Bellow assemblies are manufactured in GMP facilities with ISO clean room areas and comply with various international standards and guidelines such as USP, ISO and CFR for biosafety, bioburden, bacterial endotoxins, and particulate matter.