Troubleshooting & FAQ

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Troubleshooting

Troubleshooting
Troubleshooting
faq icon

POWER – MINI BASE

I am having issues powering up the Base Unit

  • Verify that the Base Unit is plugged into a functional electrical outlet
  • If you are using a power strip or a surge protector, verify that its switch is also turned on
  • Unplug the Base Unit from the outlet and re-plug it into the outlet

AGITATION – MINI BASE

Note: The display gets updates from the motor several times per revolution and thus may result in the displayed rotational speed oscillating between a few RPMs

I am having issues with agitation

  • Verify that the Base Unit is powered up properly
  • Verify that the Single-Use Vessel is sitting securely and all the way down in the Base Unit to ensure proper magnetic coupling
  • Verify that the Speed Adjust Dial is not in the off position
  • Visually determine any faults in the Vertical-Wheel Impeller (Look for any visible damage to the impeller) (See if the impeller is rotating smoothly in its bearings)

TEMPERATURE

The “Temperature” button says “Interlock”

  • Resolve the condition preventing the main heater from turning on (For more information, refer to the “Interlocks” subsection under “Temperature” on page 97 of the PBS 3 MAG or page 121 of the PBS 15/80 MAG User Manual)

MAIN GAS

The “Main Gas” button says “Interlock”

  • Resolve the condition preventing the gases from flowing (For more information, refer to the “Interlocks” subsection under “Main Gas” on page 98 of the PBS 3 MAG or page 123 of the PBS 15/80 MAG User Manual)

There is a problem with the Main Gas line

  • Confirm that all gas lines are connected properly and set to appropriate source pressures\
  • Check that the "Gas Data" settings are correct

I do not require nitrogen gas

  • Confirm that the DO “N2 Manual Max (%)” and “N2 Auto Max (%)” settings are ‘0’

DOOR

The following applies only to 15L and 80L bioreactors

The door will not unlock

  • Resolve the condition interlocking the controls (For   more   information,   refer   to   the   “Interlocks”   subsection   of “Door” on page 134 of the PBS 15/80 MAG User Manual)

POWER – MINI BASE

I am having issues powering up the Base Unit

  • Verify that the Base Unit is plugged into a functional electrical outlet
  • If you are using a power strip or a surge protector, verify that its switch is also turned on
  • Unplug the Base Unit from the outlet and re-plug it into the outlet

AGITATION – MINI BASE

Note: The display gets updates from the motor several times per revolution and thus may result in the displayed rotational speed oscillating between a few RPMs

I am having issues with agitation

  • Verify that the Base Unit is powered up properly
  • Verify that the Single-Use Vessel is sitting securely and all the way down in the Base Unit to ensure proper magnetic coupling
  • Verify that the Speed Adjust Dial is not in the off position
  • Visually determine any faults in the Vertical-Wheel Impeller (Look for any visible damage to the impeller) (See if the impeller is rotating smoothly in its bearings)

TEMPERATURE

The “Temperature” button says “Interlock”

  • Resolve the condition preventing the main heater from turning on (For more information, refer to the “Interlocks” subsection under “Temperature” on page 97 of the PBS 3 MAG or page 121 of the PBS 15/80 MAG User Manual)

MAIN GAS

The “Main Gas” button says “Interlock”

  • Resolve the condition preventing the gases from flowing (For more information, refer to the “Interlocks” subsection under “Main Gas” on page 98 of the PBS 3 MAG or page 123 of the PBS 15/80 MAG User Manual)

There is a problem with the Main Gas line

  • Confirm that all gas lines are connected properly and set to appropriate source pressures\
  • Check that the "Gas Data" settings are correct

I do not require nitrogen gas

  • Confirm that the DO “N2 Manual Max (%)” and “N2 Auto Max (%)” settings are ‘0’

DOOR

The following applies only to 15L and 80L bioreactors

The door will not unlock

  • Resolve the condition interlocking the controls (For   more   information,   refer   to   the   “Interlocks”   subsection   of “Door” on page 134 of the PBS 15/80 MAG User Manual)

General

General
What are the major benefits of the Vertical-Wheel Bioreactor over existing technology?
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The major advantage of the VW Bioreactor over existing systems is the broad scalability that it can offer, from the R&D and bench-top scale to cGMP production scale.  Since all of our bioreactors use the same mixing mechanism, a bench-top unit can be used as a representative scale-down model during early-stage process development, as well as process characterization for the large scale bioreactors.  In addition, the power input (from the buoyancy of gas) dissipated over a larger mixing device creates more uniform and gentle fluid motion, which provides a lower shear environment even at large scale (estimated by CFD analysis using ANSYS Fluent and STAR-CCM+® software).  This technology has the potential to accelerate time to market by virtually eliminating the potential technology transfer challenges that are often encountered as a process moves from R&D phase to clinical and commercial phases.  Finally, the  VW-Wheel bioreactors have the smallest comparative footprint and are the easy to install and use.

The major advantage of the VW Bioreactor over existing systems is the broad scalability that it can offer, from the R&D and bench-top scale to cGMP production scale.  Since all of our bioreactors use the same mixing mechanism, a bench-top unit can be used as a representative scale-down model during early-stage process development, as well as process characterization for the large scale bioreactors.  In addition, the power input (from the buoyancy of gas) dissipated over a larger mixing device creates more uniform and gentle fluid motion, which provides a lower shear environment even at large scale (estimated by CFD analysis using ANSYS Fluent and STAR-CCM+® software).  This technology has the potential to accelerate time to market by virtually eliminating the potential technology transfer challenges that are often encountered as a process moves from R&D phase to clinical and commercial phases.  Finally, the  VW-Wheel bioreactors have the smallest comparative footprint and are the easy to install and use.

General

General
How is the temperature of the culture controlled?
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The temperature of the culture is measured non-invasively by resistive temperature detectors (RTD) on the non-disposable housing unit.  Once the vessel/bag has been installed, the RTD on the housing comes in direct contact with the back portion of the vessel/bag and is sufficiently insulated from the conductive metal housing to ensure that it accurately measures the temperature of the vessel/bag.  The temperature of the culture can be maintained at a set point using the automatic mode of our temperature control.  Heat is applied to the vessel/bag as needed using heating pads placed along the bottom curvature of the housing.

The temperature of the culture is measured non-invasively by resistive temperature detectors (RTD) on the non-disposable housing unit.  Once the vessel/bag has been installed, the RTD on the housing comes in direct contact with the back portion of the vessel/bag and is sufficiently insulated from the conductive metal housing to ensure that it accurately measures the temperature of the vessel/bag.  The temperature of the culture can be maintained at a set point using the automatic mode of our temperature control.  Heat is applied to the vessel/bag as needed using heating pads placed along the bottom curvature of the housing.

General

General
Does the Vertical-Wheel Bioreactor System accommodate pH and DO sensors? Will they be reusable or single-use?
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All VW systems larger than PBS MINI will come equipped with pH and DO control capabilities, with redundancies in measurements for PBS 80.  There is an option to use reusable sensors or single-use sensors depending on customer's request.  PBS MINI will not have active pH and DO control on the system, so it must rely on controls provided by the carbon dioxide incubator in which it will be housed.

All VW systems larger than PBS MINI will come equipped with pH and DO control capabilities, with redundancies in measurements for PBS 80.  There is an option to use reusable sensors or single-use sensors depending on customer's request.  PBS MINI will not have active pH and DO control on the system, so it must rely on controls provided by the carbon dioxide incubator in which it will be housed.

General

General
How does the gas flow control work in Vertical-Wheel Bioreactor systems?
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A gas mixture, comprised of varying composition of air, carbon dioxide, and nitrogen (if applicable), is entered or in the headspace of the vessel/bag as overlay. The exact composition will be dictated either by the user or by the automatic pH and dissolved oxygen (DO) controls.  Pure oxygen is supplemented into the vessel/bag as needed to maintain high viable cell densities during the late stage of a production cell culture process.

A gas mixture, comprised of varying composition of air, carbon dioxide, and nitrogen (if applicable), is entered or in the headspace of the vessel/bag as overlay. The exact composition will be dictated either by the user or by the automatic pH and dissolved oxygen (DO) controls.  Pure oxygen is supplemented into the vessel/bag as needed to maintain high viable cell densities during the late stage of a production cell culture process.

General

General
Is the VW impeller an essential part of the single-use vessel/bag construction?
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Yes, the disposable VW-Wheel impeller is integral to our bag design as it drives the motion of the fluid inside the vessel/bag.  The vertically-oriented wheel rotates freely about a shaft that is anchored to the vessel/bag.  All parts that come in contact with the product are made out of USP Class VI materials and disposable.

Yes, the disposable VW-Wheel impeller is integral to our bag design as it drives the motion of the fluid inside the vessel/bag.  The vertically-oriented wheel rotates freely about a shaft that is anchored to the vessel/bag.  All parts that come in contact with the product are made out of USP Class VI materials and disposable.

General

General
What kind of testing has been done on the device?
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We have performed biological testing in the VW Bioreactor in parallel with other bioreactor systems to compare the culture growth, productivity, and product quality.  In addition, fluid dynamics studies have been performed at various scales to quantify mixing time and volumetric mass transfer rate (kLa).  The fluid mixing pattern, shear stress levels, and turbulent kinetic energy dissipation rates have also been investigated using computational fluid dynamics (CFD) modeling on both ANSYS Fluent and STAR-CCM+® software.

We have performed biological testing in the VW Bioreactor in parallel with other bioreactor systems to compare the culture growth, productivity, and product quality.  In addition, fluid dynamics studies have been performed at various scales to quantify mixing time and volumetric mass transfer rate (kLa).  The fluid mixing pattern, shear stress levels, and turbulent kinetic energy dissipation rates have also been investigated using computational fluid dynamics (CFD) modeling on both ANSYS Fluent and STAR-CCM+® software.

General

General
What kind of special gas, utilities, or services are needed?
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The  VW Bioreactor System only requires electricity and compressed gasses.  The bioreactors are designed to run with four gases -  air, nitrogen, oxygen and carbon dioxide - but they can also run without nitrogen.  The bioreactors are designed to connect to your Ethernet network for remote monitoring and control over the World Wide Web.

The  VW Bioreactor System only requires electricity and compressed gasses.  The bioreactors are designed to run with four gases -  air, nitrogen, oxygen and carbon dioxide - but they can also run without nitrogen.  The bioreactors are designed to connect to your Ethernet network for remote monitoring and control over the World Wide Web.

General

General
How easy is a Vertical-Wheel Bioreactor to operate?
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Our bioreactors have been designed for plug & play simplicity with our integrated software, so they are very easy to use.  As the VW Bioreactors come completely pre-configured, one only needs to plug it into an electrical outlet, connect gas supplies, and turn it on.  Some of our customers have taken delivery of VW Bioreactors in the morning and inoculated them by the same afternoon.

Our bioreactors have been designed for plug & play simplicity with our integrated software, so they are very easy to use.  As the VW Bioreactors come completely pre-configured, one only needs to plug it into an electrical outlet, connect gas supplies, and turn it on.  Some of our customers have taken delivery of VW Bioreactors in the morning and inoculated them by the same afternoon.

General

General
I already have a Distributed Control System (DCS) in my facility. Can I use it to control the Vertical-Wheel Bioreactor?
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All functions performed by the Hello UI can be performed on a DCS by configuring it to use HTTPS web calls. Contact app.eng@pbsbiotech.com for more details.

All functions performed by the Hello UI can be performed on a DCS by configuring it to use HTTPS web calls. Contact app.eng@pbsbiotech.com for more details.

General

General
Is the Vertical-Wheel Bioreactor qualified for cGMP applications?
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The 3L VW Bioreactor is qualified to meet cGMP requirements for product contact materials suitable for clinical trials in humans, as well as 21 CFR Part 11 software requirements. The other VW bioreactors are currently in the process of being tested for cGMP compliance, including all components of single-use vessels, hardware, and software.  All materials used in our vessel/bag that could potentially contact the drug substance conform to USP Class VI and ISO 10993 standards.

The 3L VW Bioreactor is qualified to meet cGMP requirements for product contact materials suitable for clinical trials in humans, as well as 21 CFR Part 11 software requirements. The other VW bioreactors are currently in the process of being tested for cGMP compliance, including all components of single-use vessels, hardware, and software.  All materials used in our vessel/bag that could potentially contact the drug substance conform to USP Class VI and ISO 10993 standards.

General

General
Will you provide results from you Extractables Testing?
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Extractables testing will be performed on our single-use vessels in accordance with recommendations from the Bio-Process Systems Alliance (BPSA) and BioPhorum Operations Group (BPOG).  Our test approach will be reviewed by consultants specializing in single-use bag validation, and the testing will be performed by a highly reputable contract laboratory specializing in extractables testing.

Extractables testing will be performed on our single-use vessels in accordance with recommendations from the Bio-Process Systems Alliance (BPSA) and BioPhorum Operations Group (BPOG).  Our test approach will be reviewed by consultants specializing in single-use bag validation, and the testing will be performed by a highly reputable contract laboratory specializing in extractables testing.

General

General
Can it be used for vaccine production?
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The VW Bioreactor System is a completely closed system and can handle high containment requirement applications as well as cGMP operations.  The low shear environment in the VW Bioreactor can potentially expedite and improve virus and vaccine production.

The VW Bioreactor System is a completely closed system and can handle high containment requirement applications as well as cGMP operations.  The low shear environment in the VW Bioreactor can potentially expedite and improve virus and vaccine production.

General

General
What is involved in the validation of the Vertical-Wheel Bioreactor System?
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PBS Biotech can work with you to validate our systems in your facility.  We will provide you with a comprehensive validation-ready package to assist you in your validation effort.

PBS Biotech can work with you to validate our systems in your facility.  We will provide you with a comprehensive validation-ready package to assist you in your validation effort.

General

General
What is involved in cleaning the system?
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Absolutely no cleaning is required, as each single-use vessel/bag is delivered clean and sterilized by gamma radiation prior to shipment to the customer.  The stainless- steel housing is never in contact with process fluids and can be wiped down just like any piece of laboratory equipment.

Absolutely no cleaning is required, as each single-use vessel/bag is delivered clean and sterilized by gamma radiation prior to shipment to the customer.  The stainless- steel housing is never in contact with process fluids and can be wiped down just like any piece of laboratory equipment.

General

General
How scalable is the VW Bioreactor?
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Thanks to the unique design of the VW impeller, the mixing characteristics of the VW Bioreactors are very homogeneous across all scales.  This includes mixing time, average shear rate, and turbulent energy dissipation rates.  This homogeneity greatly facilitates process scale-up from small development volumes to full production volumes.

Thanks to the unique design of the VW impeller, the mixing characteristics of the VW Bioreactors are very homogeneous across all scales.  This includes mixing time, average shear rate, and turbulent energy dissipation rates.  This homogeneity greatly facilitates process scale-up from small development volumes to full production volumes.

General

General
What is the maximum cell density for VW Bioreactors?
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Our system has proven capable of supporting viable cell densities exceeding 30×10⁶ cells/mL.  Other tests have shown comparable cell growth performance and productivity between the VW Bioreactors and other systems currently on the market, which include both traditional stainless-steel tanks and other single-use systems.  Testing has shown that our systems can achieve oxygen mass transfer rate (kLa) of up to 20 hr⁻¹ using our microsparger elements.

Our system has proven capable of supporting viable cell densities exceeding 30×10⁶ cells/mL.  Other tests have shown comparable cell growth performance and productivity between the VW Bioreactors and other systems currently on the market, which include both traditional stainless-steel tanks and other single-use systems.  Testing has shown that our systems can achieve oxygen mass transfer rate (kLa) of up to 20 hr⁻¹ using our microsparger elements.

General

General
What does the Vertical-Wheel Bioreactor use for agitation?
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All VW Bioreactor vessels/bags contain a novel, vertically-oriented impeller with internal bi-directional vanes that rotates via magnetic coupling around a fixed shaft to create a gentle, three-dimensional liquid flow pattern.

All VW Bioreactor vessels/bags contain a novel, vertically-oriented impeller with internal bi-directional vanes that rotates via magnetic coupling around a fixed shaft to create a gentle, three-dimensional liquid flow pattern.

Services

Services
Can App Eng help with customization of products (e.g., alter housing to accommodate different accessories
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PSCs grown as aggregates, MSCs grown on microcarriers, and MSC-derived exosomes

PSCs grown as aggregates, MSCs grown on microcarriers, and MSC-derived exosomes

Services

Services
Can App Eng help with customization of products (e.g., alter housing to accommodate different accessories
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Yes on case-by-case basis that does not require significant structural alterations

Yes on case-by-case basis that does not require significant structural alterations

Services

Services
I have already purchased IQ/OQ protocol once, do I need to purchase again if system configuration changed and need new execution service?
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No; for repeat customers, we would only typically quote the BQ- 005 bioreactor config sheet and the execution service, since can use same IQ/OQ protocols from the first time

No; for repeat customers, we would only typically quote the BQ- 005 bioreactor config sheet and the execution service, since can use same IQ/OQ protocols from the first time

Services

Services
IS IQ/OQ execution service included when purchasing the IQ/OQ protocols?
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No, IQ/OQ services are not included but sold separately; clients typically purchase due to PBS being qualified vendor with good system understanding, training on IQ/OQ protocol execution, and specialized calibrated tools that meet the required specs.

No, IQ/OQ services are not included but sold separately; clients typically purchase due to PBS being qualified vendor with good system understanding, training on IQ/OQ protocol execution, and specialized calibrated tools that meet the required specs.

Services

Services
What are logistics of App Eng support?
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In-person travel as primary option, remote also available

In-person travel as primary option, remote also available

Services

Services
How long is a typical contract/service agreement?
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Varies by amount of process development required but typically 4-6 months

Varies by amount of process development required but typically 4-6 months

80L

80L
I have other questions related to the 80L bioreactor.
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For biological cell culture questions, please contact our BioLab team. For bioreactor hardware-related questions, please contact our Applications Engineering team.

For biological cell culture questions, please contact our BioLab team. For bioreactor hardware-related questions, please contact our Applications Engineering team.

80L

80L
Can the 80L bioreactor fit on standard-sized lab bench?
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No, the 80L bioreactor is intended to be placed on a lab floor. Included wheels facilitate movement.

No, the 80L bioreactor is intended to be placed on a lab floor. Included wheels facilitate movement.

80L

80L
How is process-related data stored and accessed?
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You can customize how often and what kind of data will be stored on the bioreactor’s hard drive (typical storage size of X GB). Automatic downloading of data as a CSV file will go to local computer with direct LAN connection. All user login, changes, and data histories follow 21 CFR Part 11 requirements.

You can customize how often and what kind of data will be stored on the bioreactor’s hard drive (typical storage size of X GB). Automatic downloading of data as a CSV file will go to local computer with direct LAN connection. All user login, changes, and data histories follow 21 CFR Part 11 requirements.

80L

80L
Can I control and monitor the bioreactor software and ongoing culture run remotely?
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Yes, through a secure web-based connection to a remote

computer, tablet, or phone.

Yes, through a secure web-based connection to a remote

computer, tablet, or phone.

80L

80L
How can I monitor process parameters during a cell culture run?
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The 80L bioreactor’s software allows for customizable programming of process controls and real-time monitoring of parameters using various sensors. Feedback loops can be used to pause a run based on deviations from a set range with remote alarm notification.

The 80L bioreactor’s software allows for customizable programming of process controls and real-time monitoring of parameters using various sensors. Feedback loops can be used to pause a run based on deviations from a set range with remote alarm notification.

80L

80L
How does the adjustable height harvest valve (AHHV) work and what is it used for?
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The AHHV can be used for rapid medium exchange: after pausing impeller agitation and letting cells settle to the bottom of single- use vessel, the AHHV extends from the bioreactor housing through a port at the bottom of vessel until it just rises above the cell bed like a periscope. At that point a port opens which draws all the spent medium just above the settled cells. The AHHV can also be used for directly drawing a representative sample of cells or complete harvesting, even while gentle agitation continues.

The AHHV can be used for rapid medium exchange: after pausing impeller agitation and letting cells settle to the bottom of single- use vessel, the AHHV extends from the bioreactor housing through a port at the bottom of vessel until it just rises above the cell bed like a periscope. At that point a port opens which draws all the spent medium just above the settled cells. The AHHV can also be used for directly drawing a representative sample of cells or complete harvesting, even while gentle agitation continues.

15L

15L
I have other questions related to the 15L bioreactor.
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For biological cell culture questions, please contact our BioLab team. For bioreactor hardware-related questions, please contact our Applications Engineering team.

For biological cell culture questions, please contact our BioLab team. For bioreactor hardware-related questions, please contact our Applications Engineering team.

15L

15L
Can the 15L bioreactor fit on standard-sized lab bench?
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No, the 15L bioreactor is intended to be placed on a lab floor. Included wheels facilitate movement.

No, the 15L bioreactor is intended to be placed on a lab floor. Included wheels facilitate movement.

15L

15L
How is process-related data stored and accessed?
faq icon

You can customize how often and what kind of data will be stored on the bioreactor’s hard drive (typical storage size of X GB). Automatic downloading of data as a CSV file will go to local computer with direct LAN connection. All user login, changes, and data histories follow 21 CFR Part 11 requirements.

You can customize how often and what kind of data will be stored on the bioreactor’s hard drive (typical storage size of X GB). Automatic downloading of data as a CSV file will go to local computer with direct LAN connection. All user login, changes, and data histories follow 21 CFR Part 11 requirements.

15L

15L
Can I control and monitor the bioreactor software and ongoing culture run remotely?
faq icon

Yes, through a secure web-based connection to a remote computer, tablet, or phone.

Yes, through a secure web-based connection to a remote computer, tablet, or phone.

15L

15L
How can I monitor process parameters during a cell culture run?
faq icon

The 15L bioreactor’s software allows for customizable programming of process controls and real-time monitoring of parameters using various sensors. Feedback loops can be used to pause a run based on deviations from a set range with remote alarm notification.

The 15L bioreactor’s software allows for customizable programming of process controls and real-time monitoring of parameters using various sensors. Feedback loops can be used to pause a run based on deviations from a set range with remote alarm notification.

15L

15L
How does the adjustable height harvest valve (AHHV) work and what is it used for?
faq icon

The AHHV can be used for rapid medium exchange: after pausing impeller agitation and letting cells settle to the bottom of single- use vessel, the AHHV extends from the bioreactor housing through a port at the bottom of vessel until it just rises above the cell bed like a periscope. At that point a port opens which draws all the spent medium just above the settled cells. The AHHV can also be used for directly drawing a representative sample of cells or complete harvesting, even while gentle agitation continues.

The AHHV can be used for rapid medium exchange: after pausing impeller agitation and letting cells settle to the bottom of single- use vessel, the AHHV extends from the bioreactor housing through a port at the bottom of vessel until it just rises above the cell bed like a periscope. At that point a port opens which draws all the spent medium just above the settled cells. The AHHV can also be used for directly drawing a representative sample of cells or complete harvesting, even while gentle agitation continues.

3L

3L
I have other questions related to the 3L.
faq icon

For biological cell culture questions, please contact our BioLab team. For bioreactor hardware-related questions, please contact our Applications Engineering team.

For biological cell culture questions, please contact our BioLab team. For bioreactor hardware-related questions, please contact our Applications Engineering team.

3L

3L
Can the 3L bioreactor fit on standard-sized lab bench?
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Yes, the housing’s compact footprint is designed to sit atop standard lab benches or push carts.

Yes, the housing’s compact footprint is designed to sit atop standard lab benches or push carts.

3L

3L
How is process-related data stored and accessed?
faq icon

You can customize how often and what kind of data will be stored on the bioreactor’s hard drive (typical storage size of X GB). Automatic downloading of data as a CSV file will go to local computer with direct LAN connection. All user login, changes, and data histories follow 21 CFR Part 11 requirements.

You can customize how often and what kind of data will be stored on the bioreactor’s hard drive (typical storage size of X GB). Automatic downloading of data as a CSV file will go to local computer with direct LAN connection. All user login, changes, and data histories follow 21 CFR Part 11 requirements.

3L

3L
Can I control and monitor the bioreactor software and ongoing culture run remotely?
faq icon

Yes, through a secure web-based connection to a remote computer, tablet, or phone.

Yes, through a secure web-based connection to a remote computer, tablet, or phone.

3L

3L
How can I monitor process parameters during a cell culture run?
faq icon

The 3L bioreactor’s software allows for customizable programming of process controls and real-time monitoring of parameters using various sensors. Feedback loops can be used to pause a run based on deviations from a set range with remote alarm notification.

The 3L bioreactor’s software allows for customizable programming of process controls and real-time monitoring of parameters using various sensors. Feedback loops can be used to pause a run based on deviations from a set range with remote alarm notification.

3L

3L
How is cell sampling and harvesting performed?
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A representative sample of cells and complete harvesting are achieved through sterile tubing lines aseptically connected to vessel. Automated peristaltic pumps and hand-draw options are both available. Note: there is no adjustable height harvest valve (AHHV) available in the 3L bioreactor.

A representative sample of cells and complete harvesting are achieved through sterile tubing lines aseptically connected to vessel. Automated peristaltic pumps and hand-draw options are both available. Note: there is no adjustable height harvest valve (AHHV) available in the 3L bioreactor.

Mini

Mini
I have other questions related to the PBS MIni.
faq icon

For biological cell culture questions, please contact our BioLab team. For bioreactor hardware-related questions, please contact our Applications Engineering team.

For biological cell culture questions, please contact our BioLab team. For bioreactor hardware-related questions, please contact our Applications Engineering team.

Mini

Mini
What is the power accessory cable?
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Each Mini base unit has a cable ending in a female adapter that plugs into a DC power adapter unit, which in turn can be plugged into a wall outlet. The power accessory cable can accommodate up to four female adapters from four different Mini bases and consolidate all four into a single DC power adapter with single outlet plug.

Each Mini base unit has a cable ending in a female adapter that plugs into a DC power adapter unit, which in turn can be plugged into a wall outlet. The power accessory cable can accommodate up to four female adapters from four different Mini bases and consolidate all four into a single DC power adapter with single outlet plug.

Mini

Mini
Can I wash and re-use Mini vessels?
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We do not recommend reusing vessels due to the risk of contamination from previous cell cultures or washing chemicals.

We do not recommend reusing vessels due to the risk of contamination from previous cell cultures or washing chemicals.

Mini

Mini
How many single-use vessels do I typically need to order and/or keep on hand?
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While everyone’s cell culture process will have different requirements and vessel usage cycles, we recommend keeping at least two weeks' worth of vessels in stock. Please contact our BioLab team if you would like assistance in determining your typical usage of vessels.

While everyone’s cell culture process will have different requirements and vessel usage cycles, we recommend keeping at least two weeks' worth of vessels in stock. Please contact our BioLab team if you would like assistance in determining your typical usage of vessels.

General

General
Do all of the Vertical-Wheel Bioreactors use bags?
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Most VW Bioreactors use single-use bags made of polyvinylidene fluoride (PVDF). The PBS 3 and PBS MINI use rigid plastic vessels that are made of polycarbonate.

Most VW Bioreactors use single-use bags made of polyvinylidene fluoride (PVDF). The PBS 3 and PBS MINI use rigid plastic vessels that are made of polycarbonate.

General

General
What are the primary components of a Vertical-Wheel Bioreactor?
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The VW Bioreactor System consists of two main components: a single-use vessel/bag where cells are grown and the product is produced, and the non- disposable unit that integrates with the single-use vessel/bag.  The single-use disposable vessels and bags are available in sizes from 0.1 L to 80L working volumes.  They are sterilized by gamma radiation and shipped ready-to-use.  Each vessel/bag includes all components that are necessary for promoting cell growth, and all product-contact surfaces are made out of USP Class VI certified materials.

The VW Bioreactor System consists of two main components: a single-use vessel/bag where cells are grown and the product is produced, and the non- disposable unit that integrates with the single-use vessel/bag.  The single-use disposable vessels and bags are available in sizes from 0.1 L to 80L working volumes.  They are sterilized by gamma radiation and shipped ready-to-use.  Each vessel/bag includes all components that are necessary for promoting cell growth, and all product-contact surfaces are made out of USP Class VI certified materials.

General

General
Which applications work best with your technology?
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PBS Biotech's Vertical-Wheel (VW) Single-Use Bioreactor System has been designed for cell therapy (stem cell) processes in batch, fed-batch, and perfusion modes.

PBS Biotech's Vertical-Wheel (VW) Single-Use Bioreactor System has been designed for cell therapy (stem cell) processes in batch, fed-batch, and perfusion modes.

Services

Services
Can you tailor services based on what process stage I am in?
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Yes, we have helped clients in R&D, process development/optimization, and even clinical trial stage including first-in-human studies

Yes, we have helped clients in R&D, process development/optimization, and even clinical trial stage including first-in-human studies

Services

Services
What kinds of cell culture processes can Biolab help with?
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  • Seed expansion from a working cell bank and serial passaging
  • Aggregate-based processes including seeding, expansion, differentiation, dissociation, and harvesting
  • Microcarrier-based processes including seeding, expansion, detachment, and harvesting
  • Rapid medium exchange techniques
  • Cell separation, washing, and concentration
  • Seed expansion from a working cell bank and serial passaging
  • Aggregate-based processes including seeding, expansion, differentiation, dissociation, and harvesting
  • Microcarrier-based processes including seeding, expansion, detachment, and harvesting
  • Rapid medium exchange techniques
  • Cell separation, washing, and concentration

Services

Services
What types of cell therapy products is BioLab knowledgeable about?
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PSCs grown as aggregates, MSCs grown on microcarriers, and MSC-derived exosomes

PSCs grown as aggregates, MSCs grown on microcarriers, and MSC-derived exosomes

80L

80L
Is there any difference in performance between reusable and single- use sensors?
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Is there any difference in performance between reusable and single- use sensors?

Is there any difference in performance between reusable and single- use sensors?

80L

80L
What is the difference between floorless and floored VW impellers?
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What is the difference between floorless and floored VW impellers?

What is the difference between floorless and floored VW impellers?

80L

80L
What functions or cell culture processes is the 80L bioreactor best suited for?
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Any cell therapy application that is ready to be scaled up from 15L for clinical studies or commercial-level production.

Any cell therapy application that is ready to be scaled up from 15L for clinical studies or commercial-level production.

15L

15L
Is there any difference in performance between reusable and single- use sensors?
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There is no significant difference in sensitivity and functionality, based on internal testing and product quality assurances from third party providers of reusable (Broadley-James) and single-use (Hamilton).

There is no significant difference in sensitivity and functionality, based on internal testing and product quality assurances from third party providers of reusable (Broadley-James) and single-use (Hamilton).

15L

15L
What is the difference between floorless and floored VW impellers?
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The floorless and floored impellers are nearly identical in construction, but the latter has more panels around the circumference of the impeller. [image here] The floorless model is recommended for culturing cell aggregates while floorless is recommended for microcarriers with attached cells, due to slight variations in hydrodynamic conditions.

The floorless and floored impellers are nearly identical in construction, but the latter has more panels around the circumference of the impeller. [image here] The floorless model is recommended for culturing cell aggregates while floorless is recommended for microcarriers with attached cells, due to slight variations in hydrodynamic conditions.

15L

15L
What functions or cell culture processes is the 15L bioreactor best suited for?
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Any cell therapy application that is ready to be scaled up from 3L for clinical studies or commercial-level production.

Any cell therapy application that is ready to be scaled up from 3L for clinical studies or commercial-level production.

3L

3L
Is there any difference in performance between reusable and single-use sensors?
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There is no significant difference in sensitivity and functionality, based on internal testing and product quality assurances from third party providers of reusable (Broadley-James) and single-use (Hamilton).

There is no significant difference in sensitivity and functionality, based on internal testing and product quality assurances from third party providers of reusable (Broadley-James) and single-use (Hamilton).

3L

3L
What is the difference between floorless and floored VW impellers?
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The floorless and floored impellers are nearly identical in construction, but the latter has more panels around the circumference of the impeller. [image here] The floorless model is recommended for culturing cell aggregates while floorless is recommended for microcarriers with attached cells, due to slight variations in hydrodynamic conditions.

The floorless and floored impellers are nearly identical in construction, but the latter has more panels around the circumference of the impeller. [image here] The floorless model is recommended for culturing cell aggregates while floorless is recommended for microcarriers with attached cells, due to slight variations in hydrodynamic conditions.

3L

3L
What functions or cell culture processes is the 3L bioreactor best suited for?
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Any cell therapy application suitable at benchtop working volume, or early stage clinical studies including first-in-human trials. The 3L bioreactor is intended to further optimize processes originally developed in PBS Minis.

Any cell therapy application suitable at benchtop working volume, or early stage clinical studies including first-in-human trials. The 3L bioreactor is intended to further optimize processes originally developed in PBS Minis.

Mini

Mini
What is the best method for sampling and harvesting?
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We recommend handling any Mini vessel inside a biosafety hood for procedures such as unscrewing an orange cap and pipetting in/out of the vessel. A Mini base can be used inside the hood to securely hold the vessel in place, rather than risking a standing vessel being knocked over.

We recommend handling any Mini vessel inside a biosafety hood for procedures such as unscrewing an orange cap and pipetting in/out of the vessel. A Mini base can be used inside the hood to securely hold the vessel in place, rather than risking a standing vessel being knocked over.

Mini

Mini
How can I control process parameters in the Mini?
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The Mini base and vessel are intended to be placed in an incubator for control of temperature and gases.

The Mini base and vessel are intended to be placed in an incubator for control of temperature and gases.

Mini

Mini
What functions or cell culture processes is the Mini best suited for?
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Any small working volume cell therapy applications such as process development and optimization.

Any small working volume cell therapy applications such as process development and optimization.

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