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Bioprocessing / Single-Use Bioreactor System

BIOne

Single-Use Bioreactor System

The BIOne Single-Use Bioreactor (SUB) from Distek, Inc. is the smart choice for forward thinking laboratories who wish to increase the utility of their benchtop bioreactor models.

Customizable options above & below the headplate, allow for efficient integration of the BIOne SUB into batch, fed-batch, and perfusion process applications. The intelligent design enables effortless, drop-in compatibility of the SUB into existing autoclavable bioreactor systems.

The BIOne is the optimal vessel to facilitate the strategic development and robust characterization studies required to support complex next-generation bioprocesses. Discover more value from your next experiment with the integration of the BIOne SUB into your bioprocess!

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Convert Your Glass Vessel to Single-Use in Seconds

The gamma irradiated BIOne SUB is engineered with a disposable headplate welded to a triple-layered liner that can be easily inserted into a non-sterile bioreactor glass vessel, converting it to a disposable SUB within a matter of seconds.

2L & 5L Working Volume
Optional Single-Use pH Probe
Non-Invasive DO & pH Probe Ports
USP Class VI Materials
Animal Derivative-Free
Low Antioxidant Liner Material
Compatible with Most Manufacturers’ Glass Vessels and Controllers

Customizable Above & Below the Headplate

DO & pH Probe Ports
- Non-Invasive (Amperometric DO/Optical pH)
- PG-13.5 (Optical DO/Electrochemical pH)
- Optional Integrated Single-Use pH Probe
Pitched Blade Impeller
- Single or Dual Impeller
Sparging Options
- Flute Sparger (7 x 1.5 mm hole)
- Micro Sparger (20-40 μm pore size)
- Open Pipe Sparger (1 x 3.0 mm)
Repligen® ATF Perfusion Tube Compatible

BIOne SUB Characterization

The oxygen mass transfer within the BIOne Single-Use Bioreactor (SUB) has been extensively characterized through strategic Design-of-Experiment (DoE) analyses.
The effects of volume-dependent process parameters have been robustly modeled to allow for the accurate prediction of overall system k_La.
These data support the effective execution of process development and characterization studies, saving end-users both startup time and laboratory resources.

Non-Invasive DO & pH Probe Ports

The single-use headplate contains all of the components of your existing autoclavable system as well as several probe ports including:

Non-Invasive (Amperometric DO/Optical pH)
Two PG-13.5 universal sensor ports which can be utilized for:
- Optical DO
- Electrochemical pH
- CO_2,biomass, glucose, etc.
Optional Integrated Single-Use pH Probe

Fine Tune Your Process - Sparging Options

With our variety of sparging options and extensive characterization studies, we can fine tune your process to achieve your k_La target.

Sparging Options
- Flute Sparger (7 x 1.5 mm hole)
- Micro Sparger (20-40 μm pore size)
- Open Pipe Sparger (1 x 3.0 mm)

CLICK HERE TO VIEW THE WHITE PAPER – Increasing Oxygen Transfer within the BIOne Single-Use Bioreactor using a Microsparger.

BIOne Liner Material

The low antioxidant bioprocess film used is comprised of 3 layers, each serving a specific function:

Outer Layer (LDPE) – Mechanical Strength
Middle Barrier Layer (EVOH) – Gas Barrier
Contact Layer (ULDPE) – Cell Culture Compatible, Biologically Inert

Convert Your Glass Vessel to Single-Use in Seconds

Customizable Above & Below the Headplate

Fine Tune Your Process - Sparging Options

BIOne SUB

BIOne SUB Headplate

BIOne SUB In Vessel

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BIOne SUB Headplate with Tubing

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BIOne SUB In Vessel with Media

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BIOne SUB In and Out of Vessel

BIOne SUB with Dual Impeller

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BIOne SUB Headplate (Top View)

BIOne SUB with ATF Perfusion

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Applications

Demonstration of the Effectiveness of Design of Experiment Methodology for Strategic Upstream Process Development

Ready to expand the characterization of your Upstream Bioprocess through Design of Experiments (DoE), but unsure of how to start? Check out Distek’s latest white paper for a DoE overview that can help guide your team through the process.

In this work, we demonstrated the suitability of response surface DoE designs for both the optimization of a transient gene expression process and the characterization of oxygen mass transfer within a 2-L BIOne Single-Use Bioreactor System. CLICK HERE TO VIEW THE WHITE PAPER.

Characterizing the Effects of Antifoam C Emulsion on kLa within the BIOne SUB

To better understand and characterize the effects of antifoam supplementation on oxygen mass transfer, our team performed a dose-response evaluation of Antifoam C in both drilled-hole sparger and microsparger BIOne Single Use Bioreactors (SUBs). Within the drilled-hole sparger system, results were consistent with previously reported data. A 40 – 50% overall reduction in k_La was observed upon treatment with 30 ppm Antifoam C emulsion. In contrast, no effects from the antifoam treatment were observed within the microsparger bioreactor system. Overall, these results suggest that use of a microsparger may support consistent oxygen mass transfer within high-foaming upstream bioprocesses where antifoam supplementation is required. CLICK HERE TO VIEW THE WHITE PAPER.

Increasing Oxygen Transfer within the BIOne Single-Use Bioreactor using a Microsparger

Determining the appropriate bioreactor system configuration for an individual upstream bioprocess can be a challenging task. The nuanced details which differentiate the variety of mammalian cell culture processes will ultimately mean that certain bioreactor configurators will be preferable for specific upstream applications .In this work, we used two types of BIOne Single-Use Bioreactors (SUBs) to characterize the potential difference in oxygen mass transfer between two commonly used sparger types: drilled-hole spargers and microspargers. CLICK HERE TO VIEW THE WHITE PAPER.

Upstream Process Development with a kLa Criterion Within the BIOne Single-Use Bioreactor

The QbD directive from the FDA states that extensive bioprocess characterization and understanding should be essential elements of future bioprocess developmental work. As such, we performed novel HEK-293 batch process development within the BIOne SUB using a k_La central criterion to define operations definitions for our volume dependent parameters.

The success of this study supports the suitability of k_La as central criterion for bioprocess development. Additionally, these results demonstrated that the BIOne SUB can be highly suitable for novel upstream process developmental work. CLICK HERE TO VIEW THE WHITE PAPER.

Recognizing the Potential Impact of Agitation Directionality On Oxygen Mass Transfer Through a kLa Evaluation Within the BIOne Single-Use Bioreactor

Detailed understanding of the effects of agitation on oxygen mass transfer within a bioreactor system can help facilitate successful upstream bioprocess development and characterization. As shown in this work, the directionality of the axial flow may influence the overall k_La of a system. Process scientists, engineers, and researchers may find value in considering directionality of the axial flow as a process parameter during their own upstream bioprocess characterization and development work. CLICK HERE TO VIEW THE WHITE PAPER.

Advancing the Robust Manufacture of T-Cell Therapies through the Application of Stirred Tank Bioreactors

Stirred-tank bioreactors present an option for the expansion of primary human T-Cells that has previously not been pursued due to concerns about shear stress. Small scale studies have shown that impeller driven mixing stirred-tank bioreactors do not increase cell death or limit expansion potential. Translating the learnings from those small scale studies to the autologous manufacturing scale has shown that the BIOne stirred-tank bioreactor produces a consistent culture environment and high cell yields. The BIOne significantly outperformed rocking bioreactor systems in both total yield and production efficiency. CLICK HERE TO VIEW THE POSTER.

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