Abstract
The safety of the cells used for Advanced Therapy Medicinal Products is crucial for patients. Reliable methods for the cell purification are very important for the commercialization of those new therapies. With the large production scale envisioned for commercialization, the cell isolation methods need to be efficient, robust, operationally simple and generic while ensuring cell biological functionality and safety. In this study, we used high magnetized magnetic agarose-based beads conjugated with protein A to develop a new method for cell separation. A high separation efficiency of 91% yield and consistent isolation performances were demonstrated using population mixtures of human mesenchymal stem cells and HER2+ SKBR3 cells (80:20, 70:30 and 30:70). Additionally, high robustness against mechanical stress and minimal unspecific binding obtained with the protein A base conjugated magnetic beads were significant advantages in comparison with the same magnetic microparticles where the antibodies were covalently conjugated. This study provided insights on features of large high magnetized microparticles, which is promising for the large-scale application of cell purification.
Highlights
Advanced Therapy Medicinal Products (ATMP), such as stem-cell-based therapies [1], have gained a rapidly growing interest for the treatment of severe, often incurable, diseases.The regeneration potential of stem cells is enormous and future therapies to repair damaged cell tissue [2–4], such as cardiac cells or neurons, have only begun to be exploited [5–9].The advances in research and development for stem-cell-based therapies have created an increasing demand for reliable cell isolation methods that are efficient, robust, operationally simple and generic while ensuring the cell’s biological functionality and safety [4].Another challenge is the scale-up for commercialization of allogenic therapies where large cell quantities are manufactured
The work was initiated by assessing the biocompatibility of the commercial MAGicBeads with hMSCs
The cell isolation capability and the influence of the ligand density of these beads was tested with the model of SKBR3 cells using their human epidermal growth receptor 2 (HER2) surface receptor binding to the anti-HER2 monoclonal antibody, trastuzumab
Summary
Advanced Therapy Medicinal Products (ATMP), such as stem-cell-based therapies [1], have gained a rapidly growing interest for the treatment of severe, often incurable, diseases.The regeneration potential of stem cells is enormous and future therapies to repair damaged cell tissue [2–4], such as cardiac cells or neurons, have only begun to be exploited [5–9].The advances in research and development for stem-cell-based therapies have created an increasing demand for reliable cell isolation methods that are efficient, robust, operationally simple and generic while ensuring the cell’s biological functionality and safety [4].Another challenge is the scale-up for commercialization of allogenic therapies where large cell quantities are manufactured. Advanced Therapy Medicinal Products (ATMP), such as stem-cell-based therapies [1], have gained a rapidly growing interest for the treatment of severe, often incurable, diseases. The advances in research and development for stem-cell-based therapies have created an increasing demand for reliable cell isolation methods that are efficient, robust, operationally simple and generic while ensuring the cell’s biological functionality and safety [4]. Another challenge is the scale-up for commercialization of allogenic therapies where large cell quantities are manufactured. A major concern is the elimination of unwanted cells prior to transplantation. Cell products derived from pluripotent cells have to be imperatively free of undifferentiated cells before administration to the patient to annihilate the risk of teratoma formation [10–15]
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