Process Characterization: Applying Omics Technologies to better understand cell culture manufacturing of recombinant proteins
Project Objectives:
- Combining engineering expertise for technical understanding, bioinformatics for data mining as well as database usage, and molecular biology to gain insights into cell processes
- Characterizing biopharmaceutical production processes by transcriptome and proteome analysis – Compare fed-batch and steady state of continuous manufacturing
- Knowledge enhancement of intracellular cell behaviour in particular concerning productivity and product quality
Project Description:
The production of recombinant proteins (biologics) such as monoclonal antibodies (mAbs) is usually based on complex mammalian cell processes. Rising omics technologies have enabled the characterization of manufacturing processes on a molecular level. Getting a deeper insight into cellular mechanisms is crucial for the understanding and optimization of manufacturing processes, which is also highly promoted by regulatory agencies through the Quality by Design (QbD) initiative.
Important questions in biopharmaceutical process development include the choice between fed-batch and continuous mode as well as the elaboration of suitable scale-down models. To fulfil these complex tasks a full characterization of those processes is necessary. This is usually performed by monitoring online and offline process parameters as well as the process performance in terms of productivity and product quality. Studying the cells intracellular behaviour is one subsequent step to gain a deeper knowledge of the process. In particular, the investigation of the transcriptome and proteome can be helpful to highlight differences among the scales and processes as well as for the identification of important up- and down regulated pathways. The involved cellular mechanisms might have a significant influence on the process performance and quality of the produced biopharmaceuticals. Bioinformatics tools and functional annotation in combination with bioengineering knowledge lead to a complete picture of recombinant protein production using mammalian cell culture.
Contact Person: Vania Bertrand