Cell culture system axial

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1 Cell culture system axial A combination of fixed bed reactor and medium conditioning vessel For long time cultivation under controlled conditions Optimal for cell cultivation in serum free media High cell densities of over 10 8 /ml Modular construction of maximum of flexibility Easy adaption to different cell lines Different fixed bed carriers are possible The total sizes of the bioreactors from 0,5 l up to 17.5 l The working volumes of fixed bed vessel from 50 ml up to 6,5 l

2 A) Principle design and Medium circulation between fixed bed vessel and conditioning vessel, mixture with a peristaltic pump B) The complete system Construction of the medorex fixed bed reactor

3 How is the function of the fixed bed reactor? In conditioning vessel is the culture medium. The ph of the medium is regulated, it is aerated, the temperature of medium is optimally adjusted. The oxygen saturated culturemedium is pumped into the fixed bed vessel by a peristaltic pump. It flows with defined and adjustable Speed around the fixed bed macro porous carrier material. The cells grow on the carrier material. The spent medium flows back into the conditioning vessel, is prepared again and pumped back into the fixed bed. The system can be upgraded to a continuous system with additional feed- and harvest pump. Where are the fixed-bed bioreactors used? At production of monoclonal antibodies. At cultivation of adherent recombinant cells. At physiological tests of cells e.g. tumour cells, primary cells, cartilage-, Liver, kidney cells. Which special features characterize medorex fixed-bed reactors? High volume specific cell density > 10 8 /ml High productivity for a long time. Shear-stress-free cultivation of the cells at maximum cell gain in a serum free medium. Prevention of contamination of the cell culture e.g. by viruses, BSE etc. Flexible adaptation to most different cell lines because of special macro porous carrier material Simple and effective aeration in conditioning vessel. Simple media exchange and separation of product and cells. Easy Scale-up to the industrial Production. High operational safety. Which unusual features indicate the medorex fixed-bed reactor? Vessel combination of fixed bed and conditioning vessel for optimal functions. Simple handling clear and compact design. Easy access to all control elements. Modular conception and flexible equipment

4 Standard sizes of fixed-bed fermenter s: 0.5, 1, 2.5, 5, 17.5 l Our smallest fixed-bed bioreactors (50, 100 ml total volumes and 5, 10 ml fixed-bed volumes) are without measurement and control systems. The cell cultivation is into an incubator. Special size of 10 l is available at enquiry. Control Unit of the fixed-bed bioreactor FCU 05 The Control-Unit FCU 05 will be the Brain of the Bioreactor. In a small 19 cabinet there are all measurement amplifiers for the Sensors and additional analogue and binary in- and outputs for the complete control of the reactor. Sensors and additional in- and output signals are connected with encoded Plugs for safety contact. The Signals are converted in Standard values (0-10V, 24V) and transferred by a serial field bussystem. By using this serial field bus-system is it very easy to add several additional parameters like Redox, Conductivity e.g. The Control-Unit FCU 05 will be connected with a standard serial RS232 port to a standard PC or Laptop (USB is also available). Special IO-Cards are not necessary. All measure- and control-signals will be transferred via the RS232 to the Control-Unit. All analogue and binary signals are controlled direct by the Control-Unit. For switching higher currents the Realise are implemented there is no need for additional switching units! Pumps, Stirrer or heater are connected direct with coded Plugs to the Control Unit.

5 Process Control The complete supervising, controlling, documentation and data storage are done by the PC with the Control Software WinErs which works with Windows 2000/XP. All measured data are displayed numerical and graphical in intuitive and easy useable Process pictures. There is no need for reading boring manuals or long training on cryptic commands! All measured data are collected and stored on Hard Disk and can be archivated, and exported to other programs for editing and visualisation like Excel, MathLab e.g. also data from former experiments can be

6 Software WinErs evaluated and exported to other programs. The PC commands winer's works as a Soft-SPS, all measurements and controls. For example: For growing relevant parameters like temperature and ph are controlled and regulated by the Program. For all analogy inputs there is a two-point calibration in the visualization integrated. Changes of the measured signals by drifting of the sensors can be easy corrected.