Isolator Technology for ATMP Success

Michela Castellani-Kleinschroth, Head of MS&T at SKAN, and Koji Ushioda, President of SKAN Japan explored the Advanced Therapy Medicinal Products (ATMPs) and the journey from the research lab to GMP manufacturing. They raised awareness of the challenges of transitioning from research and development to Good Manufacturing Practice (GMP) environments, which is central. R&D processes typically rely on manual, flexible protocols and biosafety cabinets, which involve open handling and present high contamination risks. Transitioning to GMP requires adopting automated, closed systems that maintain sterility and scalability while complying with regulatory standards. Castellani-Kleinschroth emphasised that a key part of GMP readiness is designing lab protocols with the end goal in mind. This involves integrating automation and predictive analytics to handle data efficiently, ensuring scalable processes for commercial manufacturing, and selecting suitable equipment. Castellani-Kleinschroth reiterated this: “The facility has to have capability from clinical to GMP production. The team has to be trained as GMP experts and the solution which includes the other equipment has to be state-of-the-art and at the lowest risk of contamination, mainly microbial contamination.” Ushioda presented isolator technology as a superior alternative to biosafety cabinets, providing fully enclosed systems that eliminate direct operator contact with products, reducing contamination risks. These isolators enable straightforward integration of equipment such as centrifuges and incubators, ensuring all processes remain sterile within the closed system. In contrast, biosafety cabinets involve material transfers between different sterile zones making them more susceptible to contamination. Sterility assurance is a key component of ATMP manufacturing. Isolators achieve a sterility level of 10⁻⁶, which is 1,000 times better than the 10⁻³level of biosafety cabinets. This closed system approach significantly reduces microbial contamination risks, this is particularly important in autologous therapies requiring precision and patient-specific treatments. Furthermore, isolators offer operational efficiencies by reducing gowning requirements and enabling work in less restrictive environments, such as grade C cleanrooms, as opposed to the heavily regulated grade B settings for biosafety cabinets. Ushioda explained that the isolator technology has cost and environmental benefits compared to biosafety cabinets, for example, he said: “You can save the energy cost up to 50% with the isolator and environmental monitoring cost you can save up to 80%, and the initial building cost you can save up to 35%.” Automation strategies further support cost efficiency by streamlining data management and ensuring compliance with regulatory requirements. The process of technology transfer from R&D to GMP production involves planning, preparation, execution, and evaluation, supported by tools like user story mapping. Customisable and modular isolators can accommodate diverse manufacturing needs, including CAR-T therapy, stem cell processing, and tissue engineering. Therefore, this adaptability makes isolators essential for scaling ATMP production while maintaining sterility and compliance. To wrap up the presentation, Ushioda concluded: “Isolator technology is attractive to investors since it is the most effective solution to minimise the cost of bringing your product to the market. At SKAN we can offer a solution for all the stages of the ATMP manufacturing process.