Institut für Verfahrenstechnik, Umwelttechnik und Techn. Biowissenschaften
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CD-Laboratory Head Prof. Christoph Herwig

Gumpendorferstrasse 1a / 166-4

A-1060 Wien, Österreich

emailto:christoph.herwig@tuwien.ac.at

Tel:     +43 1 58801 166400

Fax:    +43 1 58801 166980

[CD]-Laboratory for Mechanistic and Physiological [M]ethods for [I]mproved [B]ioprocesses = CD-MIB

Various hosts are used for the production of heterologous proteins and secondary metabolites. Bioprocess development for the production of those bulk bioproducts is a complex task: The bioprocess not only has to fulfill economic needs by an appropriate productivity but it mainly has to ensure patient safety and therefore product quality. The process development strategy is not a simple one. It usually needs 5-8 years for one product and the processes still have high risk to fail. 

 

Figure 1: Status Quo in the Bioprocess Life Cycle

 

The complexity and needs for improvement can be shortly summarized as follows:

1) The obtained knowledge from development must be scalable. It must cover the multivariate dependencies between the process parameters on the numerous critical quality attributes of the product.

2) Synergies from former developments should be possible: The developed process is very product specific, because the physiological behavior of the host organism and the multivariate dependencies can vastly vary from product to product. Hence, the learning from former products and other developed processes is unfortunately still little to date.

3) The process has to be flexible to adapt to variations, as they occur in raw material or just due to the biological nature, but still ensuring safe product quality.

Hence, there is a strong need to introduce methods which cover above needs: The physiological interpretation of the obtained data and the understanding of biological mechanisms are of utmost importance in order to safely scale the process along its lifecycle and to extract knowledge for the further products and processes with the final goal to shorten time to market.

The major industrial needs can therefore be summarized as follows

⦁ Development of generic physiological scale-up procedures 

⦁ Reduction of process failure rate from lab-scale development to implementation at production scale

⦁ Smooth integration of new clones in production

⦁ Cost effectiveness by continuous processing