Biotechnology-based pharmaceutical products form a growth market offering high added value. With the new “Quality by Control” approach, it will be possible to control the product quality during production in the future. Bilfinger is developing new type of software for smart bioprocessing.
Bilfinger and the University of Natural Resources and Life Sciences in Vienna are shedding light on the black box which is, in many cases, the operation of a bioreactor. The bioreactor forms the core of many biopharmaceutical processes and is typically integrated in a complex plant infrastructure.
Controlling Bioprocesses Makes Production More Effizient
The bioprocesses are usually controlled indirectly by altering indirect process parameters such as pH, pO2, pressure or temperature. But what is necessary to illuminate the black box and to influence the processes occurring inside the reactor more efficiently? The answer to this question will help biotech and biopharma companies make their production more efficient in the future.
The basic problem that they are currently facing is this: critical quality characteristics such as yield or product glycosylation, which are decisive for process quality, cannot be measured directly. This results in a long and costly time to market as well as complex quality management based on the quality by testing approach.
As a result, it is only possible to determine subsequently whether the substance produced shows the necessary properties. This is done by extensive testing of the final product. In the event of any failure to achieve the desired result, the process must be restarted and the product tested again.
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