In its collective efforts to develop new drugs, the pharmaceuticals industry is making increasing use of biotechnology based on the application of natural biological transformation processes. One of the most important methods is the cultivation of microorganisms or cells in a bioreactor filled with a liquid culture medium. As drug manufacture is subject to especially strict regulations, the conditions inside the bioreactor need to be monitored precisely. Possibilities for analysis inside the reactor itself are extremely limited due to the need for thorough sterilization, with either steam or gamma rays. The use of external analyzers is therefore absolute necessary. Probes are used to check the cultivation: the probes extract samples from the medium and transfer them to an analytical system, which analyzes relevant parameters. However, a key problem with conventional sampling systems is the fact that they cause an unnecessary loss of medium in the bioreactor and often contaminate and distort the samples owing to a lack of sterility.
bbi-biotech now offers completely novel sampling systems capable of taking sterile samples from bioreactors without incurring any dead volume. The sterile boundary is in the reactor itself. Pre-rinsing is therefore not required in order to obtain a representative sample. The system consists of a disposable probe, a pump, a pneumatic unit and an innovative control mechanism. The sampling system extracts from the bioreactor no more than the quantity needed for the analysis or quality control step. The innovative way in which the sample is transported using sterile gas facilitates the automatic cleaning of the conduit system. An optional rinse can in every case prevent contamination or distortion of consecutive samples. Furthermore, the fully automatable sampling procedure can be kept very short with the help of the novel system that turns offline analysis into atline analysis. With the data being measured in real time, the status of the process can be determined immediately, or almost in real time, and regulated at once. "The new sampling systems can be employed in all process engineering applications, in other words processes in which microorganisms, for instance, are used to create a product by means of biological methods, in the biotech, pharmaceuticals, food and cosmetics industries. They work with bioreactors of all sizes and can be connected to any type of analysis instrument, including flow cytometers, enzyme sensors, mass spectrometers, HPLC and bioarrays. We thereby help protect our customers' investments in their existing equipment," explains bbi-biotech's CEO Bernd-Ulrich Wilhelm. According to Bernd Ctortecka, Patent and License Manager at Max Planck Innovation, bbi-biotech is an "innovative provider of exclusive technologies in the production of scientific instruments. The company is even in a position to supply its customers with customized, one-stop solutions for process engineering applications, including bioreactors. Our patent is a key component in the company's strategy and presents bbi-biotech's customers with completely new possibilities for monitoring, checking and managing cultivation quality."
|Contact: Markus Berninger|