This technology stabilizes eukaryotic cells by mixing them with sugars, antioxidants, polymers, and optionally proteins, then rapidly freezing and freeze-drying them to create a dry powder that maintains high cell viability for long-term storage.
The field of biopreservation and cell therapy is fundamentally challenged by the need to maintain the viability and functionality of sensitive biological materials during storage. As cell‐based treatments and research applications grow, there is increased pressure to develop processes that reliably sustain therapeutic cells for long durations without compromising their efficacy. Traditional preservation techniques are critical for ensuring a consistent supply of active, viable cells, especially for applications that demand rigorous stability and performance over time.
Current preservation strategies face significant hurdles, including unpredictable cellular degradation during freezing and drying processes. Conventional methods often induce stress-related damage such as ice crystal formation, leading to reduced cell survival and inconsistency in reconstitution outcomes. Additionally, the limited effectiveness and potential toxicity of available cryoprotectants contribute to variabilities that compromise therapeutic reliability. Such challenges underscore the pressing need for improved approaches that better mitigate cellular injury, ensure long-term storage stability, and provide uniformity in treatment performance.
This technology comprises dry powder formulations containing eukaryotic cells combined with carefully selected sugars or sugar alcohols (like trehalose, sucrose, or maltose), antioxidants (such as flavonoids, vitamins, or tripeptides), and polymers (for instance, polyvinylpyrrolidone or a triblock polyether polymer), with the optional inclusion of proteins like human serum albumin. The process involves incubating the cells in a solution with these stabilizing agents, rapidly freezing the mixture as droplets on a cryogenically cooled surface maintained well below 0°C, and then lyophilizing the frozen droplets under controlled pressure and temperature conditions. This approach yields a dry powder formulation that retains high cell viability over extended storage periods.
The technology is differentiated by its optimized composition ratios and precise processing parameters, which collectively ensure minimal loss of cell viability even during long-term storage. Its unique combination of ingredients and rapid cryogenic freezing—followed by a meticulously controlled lyophilization process—enables exceptional stability and functionality. This versatility not only supports various administration routes but also offers enhanced therapeutic potential, making it a robust platform for cell-based therapies.
This technical approach details a dry cell formulation containing eukaryotic cells, sugars (often disaccharides), antioxidants, polymers, and optionally proteins at specific weight/volume percentages. The process involves incubating cells with sugar solution, optionally including antioxidants or polymers, rapidly freezing the mixture as droplets onto a cryogenically cooled surface (0°C to -190°C), and lyophilizing under reduced pressure and temperature to yield a dry powder that preserves high cell viability over extended storage periods.