News | November 7, 2018

Reducing The Risk Of Bio-contamination In Gene, Cell And CAR-T Therapy

Bioquell’s Dr Rolf Hansen examines how the latest isolator systems create aseptic working conditions for reducing risk and keeping gene, cell and CAR-T therapies efficient, compliant and accurate, whilst also supporting biologics manufacturing expansion and enabling more patients to be treated at the same time.

Gene, cell and CAR-T therapies are the latest techniques that use genes to treat or prevent diseases such as inherited disorders and some types of cancer and viral infections. In the future, it is likely this rapidly emerging process will allow the medical profession to treat a variety of conditions by inserting a gene into a patient’s cells instead of using conventional drugs or surgery. Although a promising treatment option for certain diseases, gene therapy is a delicate process and is still being researched to ensure it is safe and effective.

Bio-contamination found in critical zones within the gene, cell and CAR-T cleanroom environment can put successful patient outcomes at risk, and also have serious financial consequences and a detrimental impact on operational resources.

The critical nature of gene therapy means it is essential to keep cells free from contamination by microorganisms such as bacteria, fungi and viruses. The risk of microbial contamination is exceptionally high during the complex cell production procedure which typically comprises multiple stages, all demanding accuracy and the highest standards of quality control.

As a result, regulators are increasingly specifying that Good Manufacturing Practice (GMP) biologics facilities be more proactive in providing an aseptic environment with sterile work areas, reagents, media and handling.

To ensure GMP compliance for stringent aseptic techniques, cell therapy companies, hospitals and service providers are choosing the latest isolator systems for containing the cell manipulation process.

Advanced isolator technology is ideal for the critical nature of gene, cell and CAR-T therapy, helping to reduce the risk of contamination by microorganisms or another patient’s cells through product handling and environmental exposure.

Offering space and energy saving benefits, isolators allow cells with limited exposure times to be quickly handled under controlled aseptic conditions and worked on with fully decontaminated tools.

Bioquell has developed the Qube work station for the aseptic processing and transfer applications widely used in gene, cell and CAR-T therapy applications. It is the only modular isolator in the world to offer Bioquell’s built in Hydrogen Peroxide Vapor technology for rapid decontamination, reduced risk and major cost benefits.

Traditional cell therapy processes require an array of bulky equipment and repeated measures to mitigate risk exposure between transfers and manipulations. The Bioquell Qube far outperforms traditional isolators for decontamination, providing an effective aseptic environment from R&D through to the manufacturing process.

Bioquell’s Qube workstation offers a guaranteed safe and productive ISO 5/EU Grade A environment for GMP compliance, providing an added level of protection from costly and hazardous bio-contamination.

Used with the Qube aseptic workstation, Bioquell’s Hydrogen Peroxide Vapor achieves more in less time by starting the decontamination cycle immediately. It eliminates the need to reach temperature or humidity levels to begin the process with the Hydrogen Peroxide Vapor providing sporicidal for a 6-log kill over every exposed surface. It is also fully compliant with the European Biocidal products regulation (528 / 2012).

Both modular and adaptable, the 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. With most organisations starting with one system, Bioquell offers the option to add chambers at a later date to suit capacity requirements.

Each 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. With peace of mind that the Qube is implementing thorough decontamination, operators can focus on the job in hand.

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

The Bioquell Qube is simple to install, does not require ventilation, can switch between negative and positive pressure and uses a standard outlet so electrical work is rarely needed.

Optional accessories such as sterility test pumps, environmental monitoring and racking options can be incorporated within the isolator.

Bioquell’s advanced isolator manufacturing process ensures product consistency, increased production efficiencies and shorter lead times.

Without a doubt, today’s modern Isolator solutions for gene, cell and CAR-T therapies create aseptic working conditions that keep this valuable, life-saving work efficient, compliant and accurate.

SOURCE: Bioquell