Xvivo GMP System

Cell Incubation and Processing Re-Invented

In contrast to conventional cell culture and processing in open incubators and open hoods and benches, the Xvivo GMP System consists of modular sets of interconnecting “clean benches”, closed incubators and closed hoods, all integrated together as co-chambers and sub-chambers each functionalized with advanced controls for performance required. Modularity allows an infinite variety of different configurations to provide exactly what you and your cells need now, and change as your needs evolve. The only constant in cell/gene therapy is change. All modules can be reconfigured as needed, expanded as needed, redeployed as needed. All are completely closed, with aseptic conditions throughout. Microscopes, centrifuges, sorters, robotics, and all other common cell tools can be integrated as well. For the first time, cell needs can be met by one efficient system.

Details of the Xvivo GMP System Design

Laminar Flow Hood - Provides a clean staging area for preparation of items entering and exiting the system and assures that any air going into an adjacent buffer chamber is HEPA filtered, same as a hood in the lab or cleanroom. This represents the first module in our “step-down” approach.  Class 100 / Grade A / ISO-5 Classification.

Buffer Chambers - Offers air-lock between outside and inside of system without compromising isolation. Displaces air with sterile HEPA filtered gas and performs variable log reduction of airborne particulates before opening inner door. Control options include: Oxygen (O2), HEPA dilution factoring, Chlorine Dioxide (CLO2) monitor/limit control, Volatile Organic Compound (VOC) monitor/limit control, particle monitor/limit control, and pressure monitor. Class 100 / Grade A / ISO-5 Classification.

Culture Processing Chamber - specialized workspace ideal for cell culture processing. Any process that is typically done in an open hood would be performed in this “closed hood”. Designed to connect with up to 3 Incubator Bank Modules or 2 Incubator Bank Modules and 1 processing chamber. Dual mode aseptic conditioning and temperature control included. Atmosphere is controlled to replicate Incubation Chambers for uninterruptible processing. The cell product never has to leave this space, whether it’s being incubated or manipulated. Control Options include: CO2, O2, Relative Humidity monitor/limit control, CLO2 monitor/limit control, VOC monitor/limit control, particle monitor/limit control, Work surface (floor) and atmosphere (gas) temperature control, Continuously Recirculating Atmosphere Conditioner, HEPA dilution factoring and pressure monitor.  Class 100 / Grade A / ISO-5 Classification.

Incubation Chamber (IC) –Up to (3) chambers mount to an Incubator Bank Module, which homogenizes the temperature within, depending on height. Interfaces with Culture Processing Chambers so door opens only into the controlled workspace. Removable rack, slide out trays for easy autoclaving and water pan for humidity are included. Each high performance incubation chamber can have different cell parameters in each simultaneously, with the exception of temperature. Control options include: CO2, O2, Temperature monitor, Relative Humidity monitor/limit control, CLO2 monitor/limit control, VOC monitor/limit control, and pressure monitor. 

General Process Chamber (GPC) - workspace for additional cell processing and/or product handling. These modules (clean bench) are typically used to enclose third party processing equipment (centrifuges, bioreactors, cell sorters, etc.) Options include: O2, CO2, HEPA dilution factoring, Continuously Recirculating Atmosphere Conditioner, Work surface (floor) and atmosphere (gas) temperature control, Relative Humidity monitor/limit control, CLO2 monitor/limit control, VOC monitor/limit control, particle monitor/limit control, and pressure monitor.  Class 100 / Grade A / ISO-5 Classification.

Specialty Modules

Deep Incubation Chamber – Same function and controls as Incubation Chambers, just different depth dimensions, allowing for increased capacity. 

Centrifuge Thermo 5500i Processing Chamber - Designed for GMP version Thermo 5500i water cooled cryofuge (customer supplied). Control options are same as General Processing Chamber.

Chilled Processing Chamber – For cell processing under chilled atmosphere condition (Customer supplied 3rd party chiller). Chiller controls chamber temperature which is monitored. Chills to as low as 4 degree C, depending on chiller, room temperature, and internal heat load of process. Control options are same as GPC.

Miltenyi CliniMACS Processing chamber – Designed for Miltenyi CliniMACS® Cell Separator. Instrument sits down inside recessed floor area for easy access to all controls and hangers. Control options are the same as GPC.

Vertical Laminar Flow Processing Chamber - Designed for applications not compatible with turbulent air flow and is capable of housing particle generating equipment. Laminar flow sweeps particles into vents in floor and re-circulates atmosphere cleaned of particles. The chamber is sized for Filling Equipment but suitable for other equipment and processes. Control options are the same as GPC.