Cell therapy and regenerative medicine technologies require strict cell manufacturing procedures to be defined and addressed. Maintenance of the aseptic environment is critical to preclude extrinsic contamination risks, similar to conventional pharmaceutical manufacturing. However, intrinsic contamination risks exist in all cell manufacturing processes owing to the use of cells as the raw materials that cannot be sterilized, thus giving rise to the primary and secondary risks of cell contamination and cross-contamination, respectively. Analysis of contamination risks was conducted on experienced batches (29,858 batches) for the production of immune cells derived from autologous blood mononuclear cells under the Medical Practitioners Act and the Medical Care Act in Japan. From these batches, 0.06% (18 cases) of contamination occurred, representing low probability of contamination incidence during cell processing. Almost all the causes of these contaminations were regarded to be from the collected blood (intrinsic contamination), and subsequent cross-contaminations were prevented, considering that the secondary contamination risk can be reduced by adequate managements of operational procedures for changeover in aseptic environment.
To prepare an autologous cell-based product in a cell processing facility, the raw material, which is collected from a patient, must first be shipped from a medical institution to the facility. The quality of this raw material varies depending on the patient, and variations due to transport methods also occur. Because the quality must be uniform and manufacturing processes need to be adjusted to account for these variations, determining the effect of shipment conditions on raw materials is very important for estimating cell manufacturability in the process design. In this study, a group of medical institutions located in different areas requested similar cell-based products processed by the same manufacturing method to a company that is licensed under the Act on the Safety of Regenerative Medicine in Japan. Manufacturing reproducibility was analyzed based on 456 cell batches received from two clinics that were processed used the same manufacturing method. The specific growth rates that were observed in the early growth phase supposed that the proliferative potential of the primary cells in the raw material was influenced by transit time. Simultaneously, the variation of the specific growth rates in the late phase were supposed to be hardly occurred. Thus, this study evaluated shipping conditions of the raw materials for an autologous cell-based product, and a strategy for verifying the influence of transportation on quality in manufacturing was suggested.
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