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

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

During the production of biopharmaceuticals, monitoring and controlling critical quality attributes and process parameters is central to ensure that the products meet the regulatory requirements with respect to safety and quality and to facilitate efficient and cost-effective production. An important goal of the biopharmaceutical industry is to lower the production costs, increase quality and sustainability in production of biologics and to reduce time-to-market of new drugs by improving the monitoring and controlling capabilities. The FDA (U.S. Food and Drug Administration) and the EMA (European Medicine Agency) since 2004 have encouraged the biopharma industry to apply process analytical technology (PAT) for real-time or near real-time bioprocess monitoring to improve testing efficiency and reduce rejects and re-processing. Traditional analytical equipment and procedures are expensive and time consuming and not suitable for real-time/near real-time applications. Despite large efforts from the research community as well as industry to develop techniques to implement PAT into bioproduction, challenges remain, and significant improvements are still highly desirable. 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.

Текст от CORDIS, на английски · Данни: CORDIS, © Европейски съюз