A bioreactor is a closed system used during upstream bioprocessing to grow cells under tightly controlled conditions. These cells can be used to produce biopharmaceuticals such as vaccines, therapeutics, gene therapies, and cell therapies.
Unlike many traditional pharmaceuticals that can be synthesized chemically, biopharmaceutical products are produced by living cells. That makes control of the cell culture environment especially important. If conditions inside the bioreactor move outside the required range, cell growth, viability, and product formation can be affected.
What Does a Bioreactor Do?
A bioreactor creates and maintains the environment required for cells to grow and perform the biological activity needed by the process.
Depending on the application, the system may control:
Gas delivery
Mixing
Temperature
pH
Dissolved oxygen
Fluid and nutrient delivery
These and other conditions may be treated as critical process parameters, or CPPs, because changes can influence cell growth, viable cell density, and the ability of the cells to produce the intended biological product.
Why Process Control Is Critical
The cells used in biopharmaceutical manufacturing are sensitive to changes in their environment. Maintaining the desired temperature, pH, dissolved oxygen concentration, and other process conditions therefore requires continuous measurement and adjustment.
Bioreactor control systems use sensors to measure process conditions and actuators to make the required changes. For example, a sensor may detect a change in dissolved oxygen, while the control system adjusts gas flow or another operating parameter in response.
These adjustments must be repeatable and precise throughout the culture because even relatively small deviations can affect cell behavior or the resulting product.
Bioreactors in Upstream Bioprocessing
Upstream bioprocessing covers the stages from cell line development and cultivation through cell expansion and harvest. The bioreactor provides the controlled environment where much of that cell growth and production occurs.
One commonly used cell type is the Chinese hamster ovary, or CHO, cell. Mammalian cells such as CHO cells are widely used because they can produce complex biological molecules required for certain biopharmaceutical products.
The cells move through a lifecycle that includes:
Lag phase
Growth phase
Stationary phase
Death phase
During the productive portion of the culture, the cells perform the biological function required by the process, such as secreting a desired protein.
Process duration varies by application. As one example, a fed-batch cell culture may run for approximately 10 to 14 days.
Why Bioreactor Data Must Be Closely Controlled
Biopharmaceutical manufacturing is subject to strict process control and validation requirements. Process variables are typically monitored and recorded throughout a production run so the manufacturer can demonstrate that the culture remained within established conditions.
Unexpected deviations may require investigation and can affect whether a batch meets established process requirements.
This makes accurate measurement and control an essential part of bioreactor operation, not simply a matter of improving efficiency.
Key Components of a Bioreactor
A bioreactor contains several components that work together to maintain the required culture environment. Common features include:
Impeller: Mixes the culture and helps distribute gases, nutrients, and cells throughout the vessel.
Sparger: Introduces process gases into the culture.
Probes and sensors: Measure conditions such as pH, dissolved oxygen, and temperature.
Aseptic seals: Help maintain the closed, controlled process environment.
Baffles: Support effective mixing within the vessel.
Feed lines: Deliver nutrients, media, or other process fluids.
Drain line: Provides a path for removing process fluid from the vessel.
Air vent: Allows controlled gas movement out of the system.
Temperature control unit: Maintains the required culture temperature.
Bioreactor Performance Depends on Stable Process Conditions
A bioreactor is more than a vessel for holding cells. It is a controlled processing system designed to maintain the environmental conditions required for living cells to grow and produce the intended biopharmaceutical product.
Reliable measurement, mixing, gas delivery, temperature control, and fluid management all contribute to keeping critical process parameters within the required range throughout the culture.
Because cell behavior and product quality can be sensitive to changing conditions, successful bioreactor operation depends on maintaining consistent control from the beginning of the culture through harvest.
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A bioreactor is a closed system used during upstream bioprocessing to grow cells under tightly controlled conditions. These cells can be used to produce biopharmaceuticals such as vaccines, therapeutics, gene therapies, and cell therapies.
Unlike many traditional pharmaceuticals that can be synthesized chemically, biopharmaceutical products are produced by living cells. That makes control of the cell culture environment especially important. If conditions inside the bioreactor move outside the required range, cell growth, viability, and product formation can be affected.
What Does a Bioreactor Do?
A bioreactor creates and maintains the environment required for cells to grow and perform the biological activity needed by the process.
Depending on the application, the system may control:
These and other conditions may be treated as critical process parameters, or CPPs, because changes can influence cell growth, viable cell density, and the ability of the cells to produce the intended biological product.
Why Process Control Is Critical
The cells used in biopharmaceutical manufacturing are sensitive to changes in their environment. Maintaining the desired temperature, pH, dissolved oxygen concentration, and other process conditions therefore requires continuous measurement and adjustment.
Bioreactor control systems use sensors to measure process conditions and actuators to make the required changes. For example, a sensor may detect a change in dissolved oxygen, while the control system adjusts gas flow or another operating parameter in response.
These adjustments must be repeatable and precise throughout the culture because even relatively small deviations can affect cell behavior or the resulting product.
Bioreactors in Upstream Bioprocessing
Upstream bioprocessing covers the stages from cell line development and cultivation through cell expansion and harvest. The bioreactor provides the controlled environment where much of that cell growth and production occurs.
One commonly used cell type is the Chinese hamster ovary, or CHO, cell. Mammalian cells such as CHO cells are widely used because they can produce complex biological molecules required for certain biopharmaceutical products.
The cells move through a lifecycle that includes:
During the productive portion of the culture, the cells perform the biological function required by the process, such as secreting a desired protein.
Process duration varies by application. As one example, a fed-batch cell culture may run for approximately 10 to 14 days.
Why Bioreactor Data Must Be Closely Controlled
Biopharmaceutical manufacturing is subject to strict process control and validation requirements. Process variables are typically monitored and recorded throughout a production run so the manufacturer can demonstrate that the culture remained within established conditions.
Unexpected deviations may require investigation and can affect whether a batch meets established process requirements.
This makes accurate measurement and control an essential part of bioreactor operation, not simply a matter of improving efficiency.
Key Components of a Bioreactor
A bioreactor contains several components that work together to maintain the required culture environment. Common features include:
Bioreactor Performance Depends on Stable Process Conditions
A bioreactor is more than a vessel for holding cells. It is a controlled processing system designed to maintain the environmental conditions required for living cells to grow and produce the intended biopharmaceutical product.
Reliable measurement, mixing, gas delivery, temperature control, and fluid management all contribute to keeping critical process parameters within the required range throughout the culture.
Because cell behavior and product quality can be sensitive to changing conditions, successful bioreactor operation depends on maintaining consistent control from the beginning of the culture through harvest.
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