Next Level Vaccine Production Processes
Bioprocess development generates extensive data (from in silico or in vitro experiments) that must be analyzed using a properly structured methodology. This data can be generated from diverse sources and it can include large datasets (e.g. time series, pictures, quality measurements, etc.). In order to take full advantage of the experimental work, a data logging and data analysis strategy must be clearly defined and properly executed. Only after having such a strategy, which would allow to maximize the findings from each experiment, bioprocess development can be accelerated.
Researching and developing the next generation of vaccines nowadays is a huge challenge. On one side, there is the need to optimize product quality, increase productivity and ensure quality of vaccines by robust and compliant bioprocesses. On the other side, the timeline for life-saving vaccines needs to be shortened. This is the reason why Intravacc is defining a digital strategy. Data management and real-time analytics are mission critical and therefore in focus. The data management includes all relevant process data and the real-time analytics is based on univariate and multivariate statistics and mechanistic modeling.
Digitalization and Data Analytics
During the past years, the lab digitalization and sensor technology have improved tremendously. The accumulated data from R&D and Quality Control (QC) has an immense potential to speed up time-to-market and develop more robust processes. Only well prepared and analyzed data leads to process knowledge and, finally, to process control and continuous improvement. Thus, a robust and efficient data management and data analytics strategy is one of the most valuable concepts in bioprocess R&D. The data analytics strategy defines how to:
- Efficiently analyze the relation between process parameters and product quality / process performance.
- Develop platform knowledge by data analytics and mathematical modeling to continuously improve Intravacc’s manufacturing platform.
- Manage and document data and data insights which are compliant for further use during stage 1 process validation.
EXPUTEC and Intravacc are implementing a comprehensive platform for data management, (real-time) data analytics, multivariate statistics and mechanistic modelling. The objective of the project is to help Intravacc to optimize product quality, increase productivity and ensure quality with robust and compliant bioprocesses. The Exputec inCyght software is being designed to automate workflows at the core and is being connected to almost anything at the edge of the network. The project manager says: “We found an excellent realization partner in Exputec. The project team is very focused on our business needs and all interfaces are running smoothly and reliably. The collaboration is excellent.”
All data from upstream and downstream processes, bioreactors, spread sheets and analytical equipment is stored in a central database. In Exputec inCyght software, there is the possibility to manage all relevant bioprocess data like time series, quality measurements, spectra and microscopic pictures are managed in a single database. A consistent nomenclature of the variables is crucial for the process management and data analytics, and is defined within the project. An intelligent database search functionality for projects and products makes the work for scientists and operators more comfortable. A comprehensive user management and audit trails leads to full traceability data.
To streamline the data analytics process, Intravacc implemented real-time data analytics. Real-time data is transferred to inCyght Predictive Analytics Workbench. The scientists run visual data analytics on real-time data within the web-browser. All predictive algorithms are implemented using inCyght Python and R integrations. There is no need to import or export any data. All data is available to perform any mathematical operation, visualization or any other analytical methods.
Intravacc has developed innovative soft sensors for monitoring cell cultures. This allows to reduce expensive and maintenance intensive hardware sensors. The mechanistic models on which these soft sensors are based have been deployed at the inCyght platform. Moreover, inCyght facilitates standardized reporting for experiments and other collaboration features. And consequently, it enhances the cooperation between scientists.
Exputec is a technology-driven software and consulting company, delivering world-class services and solutions for biotechs and chemical process industry. Exputec uniquely combines software, data science and engineering competencies to solve customers’ challenges. Scientists and engineers use the inCyght® software for data management and data analytics. The inCyght® bioprocess platform enables the streamlined realization of process characterization, process validation and technology transfer projects.
Intravacc is a not-for-profit R&D organization. We develop and optimize vaccines, vaccine processes and vaccine technologies. Our aim is to substantially reduce development risks and costs of new vaccines in order to contribute to global health and equity in access to vaccines worldwide. We achieve our aim by developing and improving vaccine design, production processes, analytics and technologies. In our state-of-the-art facilities, our experienced R&D institute takes your discovery up to Phase I/II clinical trials. Furthermore, we share and transfer our knowledge and technologies to public and private partners worldwide and work on collaborative R&D.