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Research project (§ 26 & § 27)
Duration : 2020-10-01 - 2024-09-30

PURE applies scientific biological, chemical and engineering principles to develop a breakthrough technology. Recombinant spidroins incorporating reactive ncAAs at precise sites and further functionalized on demand with affinity ligands tailored for target biopharmaceuticals, provide the raw material to assemble non-woven nanofibers, as the new generation of biobased adsorbents for the future biopharma industry. PURE puts Europe in the forefront of sustainable, cost-effective, efficient and patient-oriented biopharma.
Research project (§ 26 & § 27)
Duration : 2018-09-15 - 2020-03-14

Statistics are procedures that combine, organize, and summarize data to extract information. While the collected data are initially unorganized and ‘raw’, statistics allows the organization of the raw data into a condensed and more meaningful structure. This enables the examination and quantification of relationships among variables to show trends and investigate whether a theory or hypothesis is supported by the data. Statistics reaches from simple calculation of mean values and standard deviations to the complex fields of variable selection in high-dimensional data sets and hybrid modelling to integrate many different sources of information into a knowledge base. Biopharmaceutical process development is commonly very empirically driven and needs a large number of experiments delivering corresponding data from diverse analytical tools and monitoring processes. Statistical evaluation of such data to determine precision, accuracy, reproducibility, and robustness of measurements are daily business for all scientists. High throughput methods for screening, process development and analytics were set up and are current routine in many companies. Both lead to an exponential increase of included variables and parameters, and consequently, to huge expansion of the amounts of data. Furthermore, the release of the PAT guidance by the FDA in 2004 as the enabling aspect of Quality-by-Design in biopharmaceutical production changed the perspective on data interpretation including the need for modelling strategies, for predictability and evaluation of data in real time or close to. To address the above-mentioned challenges and needs a collaboration project shall be started between the Process Science Department of BI RCV and BOKU Vienna. It will include a postdoctoral position under the joint supervision of 2 key researchers one with a strong statistics background and the other one with established experience in bioengineering and downstream processing
Research project (§ 26 & § 27)
Duration : 2014-04-01 - 2017-03-31

Automation and miniaturization of process development is the key to accelerate the way to the market and reduce the costs of goods by reducing the need of personnel, material and time throughout process development. Therefore, high effort had been put on the development of high throughput screening systems in up and downstream of bioprocesses within the last decade. While different formats for HTS have been established and evaluated for upstream, only for some operation units in downstream processing appropriate systems have been developed and evaluated so far. Most of the published data are focused on chromatographic process steps with automated HTS for resin screening and working conditions, some are available for IB solubilization, protein refolding and protein extraction by ATPS. Few or no data are available about automation of cell disintegration, capture steps, and protein precipitation. A direct connection of automated process development of fermentations to the subsequent downstream process has not been published so far. The overall goal of present project is reduction of time and costs for process development of biopharmaceuticals compared to conventional screenings. A HT platform enabling the automated screening of the entire bioprocess development steps connecting a HT fermentation platform with automated downstream processing and analytics will be established. This will be done by integration and tech transfer of new unit operations (cell disintegration, IB solubilization as first priority; protein precipitation, ATPS as second priority) into existing HT systems. Furthermore, supplementary analytical methods will be evaluated and integrated into the process development chain. General protocols and working modules for downstream HT systems will be compiled for soluble and insolubly expressed products.

Supervised Theses and Dissertations