Product Confidence. Process Scalability.
Manufacturing is a strategic asset in cell therapy. Planning to scale a flask-based process can be complicated and time consuming; it requires a significant investment in labor and resources and may introduce complexity and variability to your manufacturing process. The early adoption of an automated cell culture platform can help streamline your process and reduce the obstacles to manufacturing scale-up or scale-out.
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.
Quantum System Overview
Quantum System Features and Benefits
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The Product is the Process
Gain Product Confidence with a Reproducible Process
At the heart of any cell culture process is a product intended to reach patients. As cell therapy advances toward commercialization, the demand for a consistent and effective product increases. A reproducible cell culture process is critical to meeting this demand because it can enable you to more efficiently produce a consistent, clinically relevant therapeutic dose, which is critical to the successful development and commercialization of your product.
Improve Process Scalability Through Automation
Every cellular product is the result of a complicated cell culture process, making large-scale replication critical to cell therapy commercialization. Therefore, an automated cell culture platform, such as the Quantum system can be advantageous to adopt before commercialization.
The Quantum system’s automation supports process scalability in several ways. First, it can help control production costs associated with manual flask-based culture. Second, it can reduce process complexity and increase oversight of your manufacturing process. Third, it can reduce revalidation efforts and process changes. Together, these benefits provide speed, simplicity and cost savings to commercial scale-up or scale-out.
Control Production Costs
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.
Reduce Process Complexity
Consistently reproducing a cell culture process may be difficult with flask-based methods, especially in large-scale production. Manual technique can differ between operators, presenting the risk of batch-to-batch variability. Furthermore, there may be a risk of operator error, failure or contamination due to the high level of hands-on attention required throughout the cell culture process. The early adoption of an automated cell culture platform such as the Quantum system, can help reduce process complexity to give you increased oversight of your manufacturing process during scale-up or scale-out.
Reduce Repeated Validation and Process Changes
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 you time and money, delivering your cellular product to market with greater speed and efficiency.
Quantum System Overview
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.
Automated Cell Seeding, Reagent Addition, Feeding and Harvest
The Quantum system uses a number of pre-defined tasks that can be customized to replicate the manual cell culture process for a range of adherent cell types including mesenchymal stem cells (MSCs) and fibroblasts. These tasks automate cell seeding, reagent addition, feeding and harvest. Cells are harvested in as few as 20 minutes.
Process Control and Protocol Flexibility
Continuous temperature control, cell feeding and waste removal provide process control over the cell culture environment. The Quantum system is controlled by a touch screen user interface, which allows operators to monitor and adjust key cell culture process parameters. It can also be configured to match the needs of a particular cell type, providing protocol flexibility.
Software to Address cGMP and Associated Part 11 Compliance
The Quantum system is the only closed, automated cell expansion system that provides reporting, remote alarms, user authentication and power failure recovery features, providing more control over the cell culture process, aiding in cGMP and associated Part 11 compliance.
Three Dimensional (3D) Hollow-Fiber Bioreactor Maximizes
Surface Area-to-Volume Ratio
The Quantum system’s 3D, functionally closed bioreactor contains about 11,500 hollow fibers with a surface area of 2.1 square meters. The large surface area is designed to maximize adherent cell expansion in a minimal amount of space. The Quantum system has the highest cell culture surface area-to-volume ratio of any closed, automated cell expansion system on the market.
Reduce Open Events with a Closed Cell Culture Environment
The hollow-fiber bioreactor provides a defined and stable geometry which allows for the control and management of the cell culture environment. The closed environment of the bioreactor remains intact during the cell culture process, removing open events and hands-on tasks associated with manual flask-based culture. The reduction of manual tasks reduces operator error and decreases the risk of contamination or failure.
Quantum System Features and Benefits
Product confidence is supported by the ability to consistently produce a safe and effective cellular therapy. The Quantum system helps create product confidence through:
Process scalability allows the reduction of manual processes and the control of production costs to enable large-scale cell therapy manufacturing. The Quantum system can create process scalability through:
How It Works
Manual versus Automated Comparison Video