The Quantum system is an automated cell culture platform that can help simplify the open, labor-intensive manual tasks associated with flask-based culture. Cell culture processes can be optimized and configured on the Quantum system to match the needs of a particular cell type. The combination of protocol flexibility and process automation can provide a significant cell culture advantage over flask-based methods, making the Quantum system ideal for a range of production scenarios, from benchtop research to current good manufacturing practice (cGMP) commercial manufacturing.
It can be advantageous to adopt an automated cell culture platform, such as the Quantum system, before commercialization when large-scale replication becomes necessary.
The investment required to produce cells using flask-based culture—in skills, resources and time—may become more cost-prohibitive as a product progresses through clinical trials. An automated cell culture platform, such as the Quantum system, makes it possible to eliminate numerous manual hands-on tasks and open events. This can result in a 70 percent reduction in labor.1
Consistently reproducing a cell culture process may be difficult with flask-based methods, especially in large-scale production. Manual techniques can differ between operators, presenting the risk of batch-to-batch variability. There may also be a risk of operator error, failure or contamination due to the high level of hands-on attention required throughout the cell culture process. Early adoption of an automated cell culture platform, such as the Quantum system, can help reduce process complexity to produce increased oversight of your manufacturing process during scale-up or scale-out.
An automated cell culture platform, such as the Quantum system, allows you to lock in a reproducible cell culture process early, which can reduce revalidation efforts later. Fewer revalidations and process changes can save time and money, delivering your cellular product to market with greater speed and efficiency.
The Quantum system is an automated cell culture platform that can help simplify the open, labor-intensive manual tasks associated with flask-based culture, helping improve the reproducibility and scalability of your cell culture process to meet your overall manufacturing requirements.
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.
The Quantum system goes beyond automating your cell culture process with system advancements that aid in your compliance efforts and features that help address the increasing importance of current good manufacturing practices (cGMPs) and activities associated with Part 11 compliance.
Automate your manual recording with electronic data capture for each step of your cell culture process. From loading the system through harvest, you can now easily run, view or download various detailed reports for each task performed.
Stay informed with customizable, remote alarm notifications. Whether you are down the hall or across town, you will know what happened and can decide if you need to return to the lab.
Provide greater control of your process, tracking tasks and configuration changes performed by operators and administrators for improved traceability.
Power failure recovery
Restore the system to the previously running state. Whether the power was down for seconds or minutes, the previous system task is restored and reports are updated.
For more information on cGMPs and activities associated with Part 11 compliance, please refer to the U.S. Food and Drug Administration (FDA) Code of Federal Regulations Title 21.
The Quantum system is now available with the Research Use Only (RUO) Cell Expansion Set R17.
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