About this Research Topic
Cell based therapies make promises to build an additional pillar of the health care system. They have shown initial clinical responses in tissue regeneration, cancer treatments and autoimmune disease treatments. In order to make cell therapies available to a larger number of patients they both need to be involved in clinical development programs and can be manufactured efficiently.
Besides the biological processes involved in making cell therapies possible engineering skills are required to identify suitable manufacturing equipment, efficient methods for process design, criteria for selecting starting materials and raw materials, design analytical assays and identify tools for data collection and trending and bioprocess simulation.
Within the, mostly patient specific, manufacturing workflow for generation of the required amount of functional cells, clinical grade purity and ex vivo expansion are crucial. The final in vivo therapeutic efficacy of a cell product depends to a large extent on the manufacturing process, especially the impact of the process on the functionality and Critical Quality Attributes (CQAs) of cells.
Equipment used in cell therapy manufacturing has been either developed for this purpose or adopted from more traditional bioprocessing or transfusion medicine. Process development for cell based therapies typically requires a combination of multiple devices, liquid transfer between the related disposables (bags, tubing sets) and process design within the limits of instrumentation required. Process design can involve pragmatic compromises to either aim for optimized process performance and performance according to the needs for e.g. Phase I, Phase II, Phase III clinical trials.
This research topic compiles information on selection of bioprocessing equipment, establishment of process performance, defining analytical requirements (in process control, in process monitoring, release testing), material selection and tools selection with a view on scalability of the cell therapy manufacturing process to allow for availability of products according to patient needs. Considering the complexity of culture and analysis, mathematical models as part of Digital Twins are essential to improve the development and basic understanding of the process.
This research topic collects information on the engineering view on process design / development for cell based therapies and combines review articles, original publications on process development, optimization and performance, comparison of processes using different equipment and an assessment of how well available equipment, disposables fulfill the needs of the cell therapy field in both companies and academic environments.
Besides the biological processes involved in making cell therapies possible engineering skills are required to identify suitable manufacturing equipment, efficient methods for process design, criteria for selecting starting materials and raw materials, design analytical assays and identify tools for data collection and trending and bioprocess simulation.
Within the, mostly patient specific, manufacturing workflow for generation of the required amount of functional cells, clinical grade purity and ex vivo expansion are crucial. The final in vivo therapeutic efficacy of a cell product depends to a large extent on the manufacturing process, especially the impact of the process on the functionality and Critical Quality Attributes (CQAs) of cells.
Equipment used in cell therapy manufacturing has been either developed for this purpose or adopted from more traditional bioprocessing or transfusion medicine. Process development for cell based therapies typically requires a combination of multiple devices, liquid transfer between the related disposables (bags, tubing sets) and process design within the limits of instrumentation required. Process design can involve pragmatic compromises to either aim for optimized process performance and performance according to the needs for e.g. Phase I, Phase II, Phase III clinical trials.
This research topic compiles information on selection of bioprocessing equipment, establishment of process performance, defining analytical requirements (in process control, in process monitoring, release testing), material selection and tools selection with a view on scalability of the cell therapy manufacturing process to allow for availability of products according to patient needs. Considering the complexity of culture and analysis, mathematical models as part of Digital Twins are essential to improve the development and basic understanding of the process.
This research topic collects information on the engineering view on process design / development for cell based therapies and combines review articles, original publications on process development, optimization and performance, comparison of processes using different equipment and an assessment of how well available equipment, disposables fulfill the needs of the cell therapy field in both companies and academic environments.
Keywords: Cell Culture, Process Analytical Technology, ATMP, Quality by Design
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