Cell culture refers to the process of removing cells from an animal or a plant and have them grow under controlled conditions mammalian cell harvesting outside their natural environment. The FUNDAMIX® has a long tradition single use bioprocessing of more than 30 years as an agitating device of cell cultures. With the absence of any rotating part, the FUNDAMIX® allows complete isolation from the environment and hence is ideally suited. Single-use agitator with a simple membrane sealing which is mechanically fixed to the shaft you are assured of an absolutely sterile environment. There are no requirements for a mechanical seal or a magnetic drive.
· Tetanus Vaccine Production
As the product is hazardous for the operators, absolute tightness must be guaranteed. The FUNDAMIX® possesses a serializable disposable filter membrane sealing without rotating parts and prevents any type of leakage. After production the contents can be sterilized without any exposure to the environment.
For smaller lab equipment in glass the FUNDAMIX® mixing device can be sterilized together with the equipment in an autoclave.
The FUNDAMIX® allows soft mixing without creation of vortexes. This advantage is used to remove toxic fermentation gases which are produced during the anaerobic fermentation. These gases are collected and have to be incinerated to avoid health risks of the operators and emission to the environment.
· Mammalian Cell Cultures
Mammalian cells are now an essential part in the pharmaceutical industry and used for the production of therapeutic proteins such as interferons, blood clotting factors, enzymes, vaccines and monoclonal antibodies. As these cells are more fragile than bacteria it is important to treat them cell recovery with absolute care.
The FUNDAMIX® is an ideal mixing device for mammalian cells as its low shear forces prevent fracture of the sensitive cells.
But an important factor for choosing the FUNDAMIX® is its ability to move large volumes of liquid without affecting the soft membranes of the mammalian cells. This produces homogeneous fluids in short times single-use clarification and prevents clogging, agglomeration or sedimentation. The vibrating action induces a high degree of random distribution without baffles and at very low shear effects on the cells.
There is no foam formation due to the absence of a vortex and the energy input is only a fraction of a rotating agitator.
· Trypsinization
Cells which are immobilized on a carrier and are grown in this form eventually need to be separated from the carrier for harvesting. This can be a tricky step and cannot be achieved by mechanical means such as shaking or mixing. By the addition of Trypsin certain peptide bonds are hydrolyzed which facilitates segregation of cell and carrier. However, to complete the separation shaking is still required. With the use of the FUNDAMIX® such shaking can be accomplished in-situ. A number of mixing plate designs have been developed over the years to improve segregation. The low shear forces prevent further decomposition of the cells.
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