Increasing demand from the global gene and cell therapy industry as well as sterility testing applications for medical devices, pharmaceuticals and tissue samples

Bioquell UK Ltd one of the leading global experts in reducing the risk of bio-contamination in the healthcare, life science and pharmaceutical markets – is celebrating the sale of its 200th Bioquell Qube from its state-of-the-art facility in Andover in the UK. This milestone high performance isolator has been supplied to a major international pharmaceutical company.

Bioquell is reporting increasing demand from the rapidly emerging gene and cell therapy industry, as well as sterility testing applications across the UK, USA, France, India and Indonesia. The company attributes the Bioquell Qube’s growing success to its modular and flexible design as well as its capacity for high throughput in a small footprint.

Ian Johnson, Bioquell’s Executive Chairman, comments: “Bioquell can be proud of setting another milestone with the production of the 200th Bioquell Qube aseptic workstation. In fact, I am delighted to report that we have seen a 90% increase in sales of the popular isolator system compared to the same period last year.

“Bioquell uses the latest designs, best materials and efficient in-house manufacturing processes allowing us to deliver consistent quality, cost efficiencies and fast lead times including system validation. As a result, we have successfully created an advanced workstation that can be tailored to meet our customers’ needs on a global basis.”

Bioquell’s Qube aseptic workstation incorporates the company’s innovative Hydrogen Peroxide Vapour technology for rapid bio-decontamination, reduced risk and major cost benefits. It achieves more in less time by starting the decontamination cycle without needing to first reach temperature or humidity levels to begin the process. The Hydrogen Peroxide Vapour provides a 6-log sporicidal kill over every exposed surface.

Equipped with an optional, integrated Merck Millipore Sigma Symbio Flex Sterility Test Pump, the Bioquell Qube allows operators to perform sterility testing by direct inoculation or membrane filtration in an aseptic Grade A environment providing assurance of process integrity.  It also provides a controlled means of loading and removing the product from the work-station’s enclosure.

It helps ensure bulk or final products are free from the presence of viable microorganisms and typical applications include pharmaceutical and tissue materials, and many other items requiring aseptic processing.

Bioquell Qube isolator technology is also ideal for the critical nature of CAR-T, gene and cell therapy, helping to reduce the potential risk of contamination by microorganisms or another patient’s cells through product handling and environmental exposure. With operators able to sit at the Bioquell Qube work station, the transformative process can be conducted within a guaranteed safe and productive ISO 5/EU Grade A environment, providing an added level of protection from potentially costly and hazardous bio-contamination.

Bio-contamination found in critical zones within the cleanroom environment can negatively affect the gene and cell therapy process, put successful patient outcomes at risk, lead to significant financial costs and impact operational resources. As a result, regulators are specifying Good Manufacturing Practice (GMP) biologics facilities be more proactive in terms of microbial contamination control.

The Bioquell Qube’s distinctive design far outperforms traditional isolators and provides an effective aseptic environment from R&D through to the manufacturing process. The system reduces risk and supports biologics manufacturing expansion, which potentially enables more patients to be treated at the same time.

Both modular and adaptable, the Bioquell Qube offers up to three chambers (two gloves in each) with optional material pass-throughs and Rapid Transfer Ports (RTP) designed to meet workflow needs. It enables decontamination of materials in one chamber whilst operatives work in another, and offers aseptic-hold retention for typically seven days depending on protocols. For most organisations starting with one system, Bioquell offers the option to add chambers at a later date to suit capacity requirements.

Each Bioquell Qube hosts a chamber integrated with a Bioquell Vaporiser module. Operators can choose to decontaminate within this workspace only or open connecting pathways to decontaminate adjacent chambers.

Available with four levels of environmental monitoring for all viable and nonviable particle needs, the Bioquell Qube has the ability to incorporate the Merck Millipore Sigma Symbio Flex Sterility Pump and other distinctive options to ensure maximum efficiencies.

Constructed from tough and hard-wearing polypropylene, Bioquell’s Qube can be installed and validated within 12 weeks from the order date.

It incorporates a wide range of advanced features including a password protected colour touchscreen control panel interface which allows easy navigation via intuitive icons. Cycles are validated and pre-programmed for quick and simple start up.

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