Periodic Reporting for period 1 - PATGlycoPrint (Development of a new process analytical technology based on an innovative nanoplasmonic detection array for monitoring glycosylation of monoclonal antibodies)
Reporting period: 2019-05-01 to 2021-04-30
The main goal of the research project is to develop a new analytical technology that allows real-time or near real-time monitoring and control of bioproduction. The intended objective is to develop a sensor technology for detection and monitoring of glycosylation of monoclonal antibodies (mAbs) and other pharmaceutical glycoproteins in real-time. Throughout the project´s lifetime, the objective are also expanded to other bioprocess key performance indicators and critical quality attributes, including bioproduct titer and IgG aggregation. Currently, no commercially available instrument can fulfil the criteria of a PAT for real-time on-line/in-line measurements of these attributes. The host institute (Linköping University, Sweden) has previously developed a novel sensor technology using replaceable sensor chips based on gold nanoparticles (AuNPs). With a simple and flexible configuration, the sensor system is expected to facilitate real-time analysis of antibody quality attributes and can be used as a PAT for monitoring and control of bioprocesses. A parallel goal of the project is to support the researcher to resume the research activity after a career break as well as to enhance the opportunities for future employments in both academic and industrial sectors by equipping the researcher with new knowledge, skills, and networks.
The cost and time required for the development of an approved biopharmaceutical, including mAb, have been estimated to 1.2 billion dollars and 8 years, respectively. Treatment using mAbs can cost thousands of dollars per month for cancer treatment. This cost is unaffordable for many people and limits the application of these improved treatments. The success of the project will in turn contribute to lowering the cost for the patients and reduce pressure on strained health care budgets.
The action has been successfully implemented at the Laboratory of Molecular Materials (www.m2lab.se) for two years following the proposed work packages and the Gantt chart. We developed a reliable sensor system that could allow rapid at-line measurements of product titer and facilitate on-line IgG monitoring. The analysis time was reduced significantly from hours when using other traditional methods to only a few minutes with our sensor. The scientific discoveries and the results of the project up to date have laid a solid foundation for further research and development and received large interest from the biosensor community and very positive feedback from the biopharma industry. On top of that, the action provided an excellent opportunity for the researcher to carry out the research and acquire new knowledge and skills that assuredly promoted the researcher´s future career.
The research results of the work have so far been presented as one conference contribution, one open-access journal article, and two manuscripts in preparation. The research data acquired during the project is expected to contribute to one more conference abstract and two scientific papers with some additional data which will be collected after the fellowship. The developed sensor technology was also successfully tested in an industrial setting for a related therapeutic protein, a single-domain antibody (dAb), in different process steps up to pilot scale. Furthermore, the research work was also presented in three division seminars at the host and showcased in “European Researchers´ Night’ for a public audience. In addition, the researcher actively joined seminars held by the Grants Office of the host University to share her experience about the Marie Curie Fellowship. Finally, to increase the accessibility and reusability of the research results, poster presentation and data sets used in the published article were shared on the Zenodo repository.
For project management and knowledge transfer, the host provided significant support to the researcher with helpful feedbacks from weekly discussions and three meetings with industrial collaborators to adjust the plan and act on problems encountered during the project. To expand knowledge, networking and other research skills, the researcher attended four workshops about advanced bioproduction, grant writing, and career development as well as participated in teaching and supervising a Master student. Throughout the project, the researcher was able to engage and collaborate with several small and large companies including ArgusEye, Cytiva, and BioInvent. After the fellowship, the researcher will be hired by the host with another employment contract and continue with the current work and apply for more grants.