Abstract
Despite the advent of advanced therapy medicinal products (ATMPs) in regenerative medicine, gene therapy, cell therapies, tissue engineering, and immunotherapy, the availability of treatment is limited to patients close to state-of-the-art facilities. The SCORPIO-V Division of HNu Photonics has developed the Phoenix-Live Cell TransportTM, a battery-operated mobile incubator designed to facilitate long-distance transportation of living cell cultures from GMP facilities to remote areas for increased patient accessibility to ATMPs. This work demonstrates that PhoenixTM (patent pending) is a superior mechanism for transporting living cells compared to the standard method of shipping frozen cells on dry ice (−80°C) or in liquid nitrogen (−150°C), which are destructive to the biology as well as a time consuming process. Thus, Phoenix will address a significant market need within the burgeoning ATMP industry. SH-SY5Y neuroblastoma cells were cultured in a stationary Phoenix for up to 5 days to assess cell viability and proliferation. The results show there is no significant difference in cell proliferation (∼5X growth on day 5) or viability (>90% viability on all days) when cultured in PhoenixTM and compared to a standard 5% CO2 incubator. Similarly, SH-SY5Y cells were evaluated following ground (1–3 days) and air (30 min) shipments to understand the impact of transit vibrations on the cell cultures. The results indicate that there is no significant difference in SH-SY5Y cell proliferation (∼2X growth on day 3) or viability (>90% viability for all samples) when the cells are subjected to the vibrations of ground and air transportation when compared to control samples in a standard, stationary 5% CO2 incubator. Furthermore, the temperature, pressure, humidity, and accelerometer sensors log data during culture shipment to ensure that the sensitive ATMPs are handled with the appropriate care during transportation. The PhoenixTM technology innovation will significantly increase the accessibility, reproducibility, and quality-controlled transport of living ATMPs to benefit the widespread commercialization of ATMPs globally. These results demonstrate that PhoenixTM can transport sensitive cell lines with the same care as traditional culture techniques in a stationary CO2 incubator with higher yield, less time and labor, and greater quality control than frozen samples.
Highlights
Significant advances have been made to create advanced therapy medicinal products (ATMPs) in the form of regenerative medicine, cell therapies, gene therapies, tissue engineering, and immunotherapy
Thereafter, the cell container is loaded into PhoenixTM and the live cell culture is maintained at 37 ± 0.25◦C for the entire duration of the experiment (Figure 2B)
The neuroblastoma cell line SH-SY5Y was used as a proxy ATMP in order to examine the effects of mobile incubation on cell proliferation, viability, and morphology
Summary
Significant advances have been made to create advanced therapy medicinal products (ATMPs) in the form of regenerative medicine, cell therapies, gene therapies, tissue engineering, and immunotherapy. Though initial animal and case studies appear promising, additional clinical trials are needed to fully characterize the efficacy and limitations of ATMPs in disease management including the standardization of treatment regimens between laboratory research and clinical applications (Borlongan, 2019; Brunet et al, 2019; Fukumitsu and Suzuki, 2019). These treatment options require state-of-the-art laboratories to produce and maintain the necessary, highly sensitive cell and tissue cultures, dramatically limiting access to patients and researchers. LN2 cryopreservation during transport requires laborious, timeconsuming biological manipulations prior to therapeutic use, which is neither efficient nor plausible to expect of on-site physicians and remote medical facilities
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