Automated cell culture: product confidence, process scalability.

Within a small footprint of only 0.3 m², the Quantum system can replace the need for the incubator, biosafety cabinet and clean room typically required for flask-based culture. In addition, it can reduce the need for these workstations during cell culture by providing a functionally closed system with temperature and gas control.

When working with the number of flasks required to expand clinically relevant cell volumes, manual cell culture methods require a labor-intensive harvest procedure that can take days to complete. To expedite the process, the Quantum system features a hollow-fiber bioreactor with one intracapillary and one extracapillary flow path that completes a full harvest procedure in as little as 20 minutes. Harvested cells can be captured in a 0.5 L bag that can be sterilely sealed for downstream processing.

The 3-D commercial bioreactor used with the Quantum system contains about 11,500 hollow fibers, providing a 2.1 m² cell culture surface area, which is equivalent to the surface area of 120 T-175 flasks. The bioreactor's compact design allows a substantial amount of surface area in a minimal amount of space. This effective use of lab space results in facility, storage and workflow savings.

The Quantum system transforms open, labor-intensive manual cell culture processes into a closed, automated and reproducible process that includes four primary phases. First, the Quantum system is primed as the nutrients, metabolites and gases diffuse across the fibers in the bioreactor. Second, cells are loaded into the bioreactor. Third, media exchange begins with the continuous control of temperature, cell feeding and waste removal. Finally, cells are harvested in as little as 20 minutes.

By consolidating workstations and using a sophisticated touch screen, it is now possible for a skilled operator to manage up to 10 Quantum systems at once. This improvement in workflow efficiency not only saves space but also has been shown to provide product benefits, including less media, larger cell yields, shorter processing times, a reduction in labor up to 70 percent and a reduction in cost up to 40 percent.¹

The National Institutes of Health (NIH) analyzed bone marrow stromal cells (BMSCs) from the Quantum system to determine whether they retained their differentiation potential, resulting in three major findings. First, cell yields in all test cases were higher when cells were grown in the Quantum system compared to Cell Factories. Second, BMSCs grown in the Quantum system were found to have similar phenotypes compared to BMSCs grown in Cell Factories. Lastly, BMSCs from both the Quantum system and Cell Factories can differentiate into adipocytes. The study concluded that growth in the Quantum system does not alter the differentiation potential of the subset of stem cells within the BMSC population.

A direct gas connection allows operators to control the cell culture environment, enabling any gas blend connection to the Quantum system. An internal investigation demonstrated that hypoxic and normoxic conditions make no significant difference in cell yield, viability, or phenotypic, morphological or differentiation potential.