UNLOCKING THE POTENTIAL OF BLOOD

Quantum^®

Cell Expansion System*

Overview

How It Works

Compare Processes

Software

Research

Materials

Automated cell culture replaces cell culture flasks

Automated cell culture: product conﬁdence, process scalability.

Whether you are working in academic research, translational research or with commercial applications, if your work depends on cell culture, you may want to explore how Quantum could benefit your lab.

Quantum is an automated platform designed to simplify the open, labor-intensive tasks associated with manual cell culture.

IMPROVE YOUR CELL CULTURE PROCESSES

The Quantum process is functionally closed, reproducible and scalable. The flexible system allows your cell culture process to be optimized and configured to match the needs of your particular cell type. Quantum maintains a consistent and controlled environment, automating critical processes such as feeding cells, removing waste and exchanging gases until it is time to harvest your cells.

The combination of cell culture protocol flexibility and process automation can provide a significant advantage over flask-based methods, making Quantum ideal for a range of production scenarios, from benchtop research to current good manufacturing practice (cGMP) commercial manufacturing.

WHY TERUMO BCT

At Terumo BCT, we have earned a reputation for excellent customer service, deep expertise and a long history of helping a wide range of customers achieve their goals. Let us help you find greater success with Quantum.

Gain Product Confidence With a Reproducible Process

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 essential to the successful development and commercialization of your product.

Improve Process Scalability

It can be advantageous to adopt an automated cell culture platform, such as the Quantum system, before commercialization when large-scale replication becomes necessary.

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.¹

Reduce Process Complexity

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.

Reduce Repeated Validation and Process Change

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.

Customize Tasks

The Quantum system uses several pre-defined tasks that can be customized to replicate the manual cell culture process for a range of adherent and suspension cell types, including mesenchymal stem cells (MSCs) and fibroblasts. These tasks automate cell seeding, reagent addition, feeding and harvest. Cells are harvested in as little as 20 minutes.

Exercise Process Control and Protocol Flexibility

Continuous temperature control, cell feeding and waste removal provide process control over the cell culture environment. Control the Quantum system by touch screen; this allows operators to monitor and adjust key cell culture process parameters. The system can also be configured to match the needs of a particular cell type, providing protocol flexibility.

Address cGMP and Associated Part 11 Compliance

The Quantum system is the only closed, automated cell expansion system that features reporting, remote alarms, user authentication and power failure recovery features, providing more control over the cell culture process and aiding in cGMP and associated Part 11 compliance.

Maximize Surface-Area-to-Volume Ratio

The Quantum system's 3-D, functionally closed bioreactor contains about 11,500 hollow fibers with a surface area of 2.1 m². 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, eliminating 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.

Read about efficient manufacturing of mesenchymal stromal cells (MSCs) in the Quantum system

Read how Quantum systems increased cell production quantities from one billion cells to commercially relevant batch sizes

How It Works

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.

Incubator + Biosafety Cabinet + Clean Room = Quantum System

CELL HARVEST IN AS LITTLE AS 20 MINUTES

120 T-175 FLASKS = ONE BIOREACTOR

FOUR EASY STEPS

40% REDUCTION IN COSTS, 70% REDUCTION IN LABOR

MAINTAINS CELL CHARACTERISTICS CONSISTENT WITH FLASKS

HYPOXIC AND NORMOXIC CONDITIONS

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.

Compare Cell Culture Processes

VIDEO: See how cell-culture flasks compare to automated cell culture

Software

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 practice (cGMP) and activities associated with Part 11 compliance.

	Reporting 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.
	Remote alarms 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.
	User authentication 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 cGMP and activities associated with Part 11 compliance, please refer to the U.S. Food and Drug Administration (FDA) Code of Federal Regulations Title 21.

Research

Rethink Cell Culture

The Quantum system is now available with the Research Use Only (RUO) Cell Expansion Set R17.

Get serious about cell separation

Go from apheresis product to separated cells in just one hour.

Quality collections count

How to deliver high target cell collection for today's therapies.

Making the connection

Sterile tubing connections you can count on.

Materials

Applications Cell Types Publications Customer Testimonials/Press

See the full materials list

For access to manuals, instructions for use and other technical documentation, please log in or register.

*Customers are responsible for validating the use of the Quantum system to expand cells for their intended therapy.

¹Terumo BCT, "The Quantum Cell Expansion System's Valuable Role in Cell Production Requirements for ReGenesys," April 2014, part number 306650191C.

UNLOCKING THE POTENTIAL OF BLOOD

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