The Corning® Ascent® FBR PD System for cell and gene therapy workflows

The Corning Ascent FBR PD System is intended to provide process development and production scale cell culture capacities for cell and gene therapy workflows.

The system is designed to provide viable cell harvest capabilities, allowing it to be used as a seed train and other applications that require the ability to harvest vast amounts of cells, such as regenerative medicine.

Three single-use Ascent FBR bioreactor sizes, 1 m2, 2.5 m2, and 5 m2, aid in the establishment of a reliable and well-defined manufacturing process.

The Corning Ascent FBR PD System is a perfusion bioproduction platform that is automated for attachment-dependent cell-based operations. The platform is intended to allow protocol development flexibility while also enabling hands-off operation during use.

The system’s consumable set includes disposable sensors for critical process parameters (pH, dissolved oxygen, temperature). All fluid-contacting components are pre-assembled, single-use, and irradiated, so autoclaving is not necessary. The system is designed to be up and running in as little as just 20 minutes.

Features and benefits

  • FBR designed to harvest viable cells with >90% recovery
    • Allows it to be used in other application operations that require cell recovery for later use
    • Allows the bioreactor to be utilized for seed train, which streamlines vessel-to-vessel cell transfer
  • Separate media condition vessel (MCV)
    • Allows for more flexibility in media volume and dilution strategy for transfection reagents before addition
  • Ready-to-use, irradiated consumables
    • There is minimal set-up, no autoclaving required, and no probe calibration is needed. The simple setup can save several hours of valuable time
  • Specially treated woven mesh polymer substrate
    • Uniform fluid flow - Efficient nutrition delivery and waste removal
    • Uniform cell growth - Improved cell distribution and confluence at transfection
    • Improves cell health and product yield
  • Automated control, including disposable sensors that monitor DO, pH, temperature
    • Reduced labor expenses, hands-off operation, and lower risk of human error
  • Bioreactor scalability
    • Ascent FBR PD system bioreactors range in size from 1 m2 to 5 m2, assisting in the establishment of a consistent and well-defined manufacturing process
  • Closed system
    • It is possible to run it outside of a laminar flow hood. Benchtop aseptic cell sampling of the bioreactor is made possible by aseptic connectors or tube welding

The Corning Ascent FBR PD system is made up of a system controller with a touchscreen Human-Machine Interface (HMI) control display and single-use, irradiated components such as a bioreactor, a media conditioning vessel (MCV), and other consumables such as tubing, connectors, probes, in-line sensors, and bottles.

The controller is operated using a touchscreen graphic user interface.

Figure 1. The controller is operated using a touchscreen graphic user interface. Image Credit: Corning Life Sciences

A recirculation pump circulates media from the MCV through the fixed bed bioreactor during cell culture. During media maintenance, a separate pump assists with removing deficient media from the MCV and replacing it with fresh media.

Feed and base pumps monitor and maintain cell culture pH and nutrient levels, while temperature-controlled heated nests keep the MCV and bioreactor at a constant temperature.

Cells are released or lysed in situ from the bioreactor at the user’s option during harvest. The HMI gives the user the option of operating the system manually or automatically.

The bioreactor design

The Corning Ascent FBR system's bioreactor is made of a carefully treated and packed polymer mesh that allows uniform, low-shear fluid flow through the bioreactor bed, promoting equally distributed cell development and increasing cell exposure to nutrients and reagents.

This has shown high yields, which could result in fewer required runs and significant cost savings in manufacturing.

The Corning Ascent FBR PD System for cell and gene therapy workflows

Image Credit: Corning Life Sciences

The system allows the FBR to be removed from the controller and transferred into a laminar flow hood for sampling. A hygienic twist clamp gives simple access to the FBR's segmented sample mesh.

The three sampling mesh discs are separated into six segments, each of which is designed to be easily removed. At various intervals, segments could be removed to monitor cell proliferation within the FBR.

Corning Ascent FBR Pilot and Production systems will be available in a variety of surface area sizes, with linear scalability from 1 m2 to 1,000 m2. They will use the same bioreactor technology as the Process Development system.

Corning Ascent FBR PD system, top view (A) and showing bottle manifold and bar code scanner, side view (B).

Figure 2. Corning Ascent FBR PD system, top view (A) and showing bottle manifold and bar code scanner, side view (B). Image Credit: Corning Life Sciences

Table 1. Main components of the Ascent FBR PD System. Source: Corning Life Sciences

Label Component
1 Human-Machine Interface (HMI)
2 Media Conditioning Vessel (MCV)
3 Fixed Bed Reactor (FBR) with sterile connectors tray
4 Bioreactor heated nest
5 Recirculation pump
6 Media pump
7 Pinch valve(s)
8 Interface panel
9 Inoculum, base, and feed bottles rack
10 Media Addition and Media Waste bottles
11 Bar code scanner

 

Site requirements

Table 2. Source: Corning Life Sciences

Type Description
Operating Conditions The instrument is designed for use under standard operating conditions per UL 61010-1 where:
  • Indoor temperature range is 5 °C to 40 °C. For optimal use, the indoor temperature range shall be between 20 °C to 30 °C.
  • Maximum relative humidity at 80% for temperatures up to 30 °C
  • Maximum altitude up to 2,000 m
  • Pollution degree 2
  • Up to IEC Overvoltage Category II for transient over voltages
Space Required A workbench suited to accommodate the equipment dimensions (L x W x H) 53 x 30 x 27 in. (134.62 x 76.2 x 68.58 cm).
The workbench shall be sized to allow additional consumables, if required.
System Weight Base weight (without consumables) is approximately 186 lbs. (84.37 kg).
Power Requirements Cat. No. 6970, 120 VAC/60 Hz/1-Phase 527 W
Cat. No. 6991, 230 VAC/50 Hz/1-Phase 595 W
One 20 amp. dedicated outlet is required
An uninterruptible power supply (UPS) and a surge protector are recommended.
Gas Connection and Type All calibrated mass flow controllers (MFCs) are rated for 30 to 35 PSIG of their respective gases.
The required connection type is 1/4" (6 mm) OD semi-rigid flexible tubing for inlet push connectors.
Communication Ethernet/IP

 

Ordering information

Table 3. Corning® Ascent™ FBR PD Controllers. Source: Corning Life Sciences

Cat. No. Description Qty/Cs
6970 Ascent FBR PD controller, 120 V 1
6991 Ascent FBR PD controller, 230 V 1
6992 Ascent FBR PD controller, 100 V 1

 

Table 4. Corning Ascent Bioreactor Consumables. Source: Corning Life Sciences

Cat. No. Description Qty/Cs
6971 Ascent FBR 1 m2 bioreactor consumable 1
6972 Ascent FBR 2.5 m2 bioreactor consumable 1
6973 Ascent FBR 5 m2 bioreactor consumable 1
6974 Ascent FBR 1 m2 bioreactor consumable with Lynx® connectors 1
6975 Ascent FBR 2.5 m2 bioreactor consumable with Lynx® connectors 1
6976 Ascent FBR 5 m2 bioreactor consumable with Lynx® connectors 1

 

Table 5. Corning Ascent Harvest Consumables. Source: Corning Life Sciences

Cat. No. Description Qty/Cs
6984 Ascent 2 L roller bottle with ¼" tubing and AseptiQuik® DC 2
6985 Ascent 3 L Erlenmeyer flask with ¼" tubing and AseptiQuik® DC 2
6966 Ascent 5 L Erlenmeyer flask with ¼" tubing and AseptiQuik® DC 2
6986 Ascent harvest consumable with 1 L wash bottle 1
6987 Ascent harvest consumable with 2 L wash bottle 1

 

Table 6. Corning Ascent Accessories. Source: Corning Life Sciences

Cat. No. Description Qty/Cs
6979 Ascent 500 mL centrifuge tube with ¼" tubing and AseptiQuik® G 2
6980 Ascent 500 mL bottle with ¼" tubing and AseptiQuik® G 2
6981 Ascent 500 mL bottle with ¼" tubing and AseptiQuik® S 4
6982 Ascent 3L Erlenmeyer flask with ¼" tubing and AseptiQuik® G 2
6983 Ascent 5L Erlenmeyer flask with ¼" tubing and AseptiQuik® G 2
6967 Ascent T-adaptor with ¼" tubing and AseptiQuik® S to G 4
6968 Ascent T-adaptor with ¼" tubing and AseptiQuik® G 4
6969 Ascent T-adaptor with ¼" tubing and AseptiQuik® S 4
6993 Ascent Accessory tubing ¼" with AseptiQuik® G 4

 

Corning Ascent FBR PD Controller.

Corning Ascent FBR PD Controller. Image Credit: Corning Life Sciences

Main Consumables (MCV and BRV) with AseptiQuik® Connectors.

Main Consumables (MCV and BRV) with AseptiQuik® Connectors. Image Credit: Corning Life Sciences

Harvest Consumables.

Harvest Consumables. Image Credit: Corning Life Sciences

Accessory Consumables.

Accessory Consumables. Image Credit: Corning Life Sciences