Summary
Glycosylation of therapeutic antibodies is one of the most critical quality attributes (CQAs) in biopharmaceutical manufacturing because of its strong impact to the treatment efficacy. Many parameters in the production process including upstream cell culture and downstream purification can significantly change the antibody glycosylation profiles. Therefore, monitoring and quality controlling of glycosylation is central to ensure high quality and consistent products. Unfortunately, this requires advanced analytical equipment and procedures that are expensive and time consuming and not suitable for on-line applications. Process analytical technologies that enable real-time monitoring of glycosylation during the production process would thus be a game changer in the biopharma industry. The aim of this research action is to develop and evaluate a new process analytical technology based on an innovative nanoplasmonic glycan-binding array that can detect the glycosylation patterns of downstream and upstream samples immediately or in a few minutes, respectively. The proposal is established to support the experienced researcher (ER), who wish to resume research in Sweden after a career break, and to enhance the ER´s employment opportunities in both academic and industrial sectors by an extensive two-way exchange of knowledge between the host and the ER as well as innovation and networking opportunities. The research project includes different branches of knowledge including biosensors, nanomaterials, biomanufacturing, analytical chemistry as well as surface, organic and peptide chemistry. In line with the MSCA-2018 Work Programme, this broad interdisciplinary training is expected to diversify the ER competence and greatly impact the ER’s future career while developing and exploring new technologies that can dramatically improve current strategies for bioproduction.
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| Web resources: | https://cordis.europa.eu/project/id/841373 |
| Start date: | 01-05-2019 |
| End date: | 30-04-2021 |
| Total budget - Public funding: | 203 852,16 Euro - 203 852,00 Euro |
Cordis data
Original description
Glycosylation of therapeutic antibodies is one of the most critical quality attributes (CQAs) in biopharmaceutical manufacturing because of its strong impact to the treatment efficacy. Many parameters in the production process including upstream cell culture and downstream purification can significantly change the antibody glycosylation profiles. Therefore, monitoring and quality controlling of glycosylation is central to ensure high quality and consistent products. Unfortunately, this requires advanced analytical equipment and procedures that are expensive and time consuming and not suitable for on-line applications. Process analytical technologies that enable real-time monitoring of glycosylation during the production process would thus be a game changer in the biopharma industry. The aim of this research action is to develop and evaluate a new process analytical technology based on an innovative nanoplasmonic glycan-binding array that can detect the glycosylation patterns of downstream and upstream samples immediately or in a few minutes, respectively. The proposal is established to support the experienced researcher (ER), who wish to resume research in Sweden after a career break, and to enhance the ER´s employment opportunities in both academic and industrial sectors by an extensive two-way exchange of knowledge between the host and the ER as well as innovation and networking opportunities. The research project includes different branches of knowledge including biosensors, nanomaterials, biomanufacturing, analytical chemistry as well as surface, organic and peptide chemistry. In line with the MSCA-2018 Work Programme, this broad interdisciplinary training is expected to diversify the ER competence and greatly impact the ER’s future career while developing and exploring new technologies that can dramatically improve current strategies for bioproduction.Status
CLOSEDCall topic
MSCA-IF-2018Update Date
28-04-2024
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