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54 BIOTECHNOLOGY


Dr Rolf Hansen examines how the latest isolator systems create aseptic working conditions for reducing risk and keeping gene, cell and CAR-T cell therapies effi cient, compliant and accurate


G


ene, cell and CAR-T cell therapies are the latest techniques that use cell manipulation to treat or


prevent diseases such as inherited disorders, some types of cancer and viral infections. In the future, it is likely this progressing fi eld will allow the medical profession to treat a variety of conditions by modifying 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 eff ective. Bio-contamination found in critical


zones within the gene, cell and CAR-T cell cleanroom environment can put successful patient outcomes at risk, have serious fi nancial consequences and also have a detrimental impact on operational resources. T e critical nature of gene therapy means it is essential to keep cells free from contamination by microorganisms such as bacteria, fungi and viruses. T e risk of microbial contamination is 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


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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 cell therapy, helping to reduce the risk of contamination by microorganisms or another patient’s cells through product handling and environmental exposure. Off ering space and energy saving


benefi ts, isolators allow cells with limited exposure times to be quickly handled under controlled aseptic conditions.


Innovative workstation T e Bioquell Qube workstation was developed for the aseptic processing and transfer applications widely used in gene, cell and CAR-T cell therapy applications. It is the only modular isolator to off er Bioquell’s built-in Hydrogen Peroxide Vapour technology for rapid decontamination, reduced risk and major cost benefi ts. T e Bioquell Qube far outperforms many traditional isolators for


The Qube workstation from Bioquell


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