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Development of a new process analytical technology based on an innovative nanoplasmonic detection array for monitoring glycosylation of monoclonal antibodies

Project description

The devil is in the details when it comes to monoclonal antibody production

Monoclonal antibodies (mAbs) enlist natural immune system functions to fight diseases. They are produced in vitro using tissue-culture techniques to generate highly specific antibodies from a single immune cell clone. The desired mABs are harvested periodically and purified from the medium in an expensive and time-consuming process. However, tissue culture and purification can have detrimental impact on antibody glycosylation (addition of a carbohydrate), a critical post-translational modification related to the safety and clinical efficacy of therapeutic antibodies. PATGlycoPrint is developing a novel platform to detect glycosylation quickly and reliably in samples from both tissue culture and from purified mABs. If successful, it could revolutionise the production of mABs with benefits for the pharmaceutical industry and patients alike.

Objective

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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MSCA-IF-EF-CAR - CAR – Career Restart panel

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Call for proposal

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(opens in new window) H2020-MSCA-IF-2018

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Coordinator

LINKOPINGS UNIVERSITET
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 203 852,16
Address
CAMPUS VALLA
581 83 Linkoping
Sweden

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Region
Östra Sverige Östra Mellansverige Östergötlands län
Activity type
Higher or Secondary Education Establishments
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 203 852,16
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