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European Biopharmaceutical Review

Exploring CO2 Incubator Technologies Designed for Cleanroom Cell Culturing

Advances in cell biology are enabling new therapy approaches for an increasing range of medical conditions, including cancer, autoimmune disorders, and infectious diseases. While growth of the global cell and gene therapy market slowed in 2020 due to the COVID-19 pandemic, it is expected to recover and reach $13 billion in 2023 at a compound annual growth rate of 24.1% (1).

Novel cell-based therapies use highly sensitive stem cells and primary cells that require carefully controlled growth conditions to reproducibly deliver the desired therapeutic effect. While long-established, immortalised cell cultures can be grown in standard CO2 incubators, stem cells and primary cells, owing to their sensitivity, must be cultivated in advanced laboratory incubators that closely replicate and maintain in vivo conditions, including temperature, carbon dioxide, humidity, and sometimes oxygen.

At the same time, regulatory authorities demand measures to reduce contaminating particulates and microorganisms in the production suite that might pose a risk to patient safety in the final product. Like procedures, personnel, training and record-keeping, production equipment must comply with GMP guidelines. CO2 incubators are no exception and should offer independently proven methods for preventing cell culture contamination to ensure compatibility with a cleanroom environment.

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Mary Kay Bates is a Senior Global Cell Culture Scientist with Thermo Fisher Scientific, where she provides cell culture expertise to colleagues and customers. Her knowledge is based on twenty years of experience in academic and industrial cell and molecular biology labs, focusing on cancer and gene therapy, and she has authored several publications. Mary Kay holds an MS in microbiology from the University of Wisconsin-Madison, US.
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