Optical Spectroscopy for the Quality Control of ATMP fabrication: A new method to monitor cell expansion and to detect contaminations
Résumé
Fabrication of Advanced Therapy Medicinal Products takes currently place
in clean and sterile environment and is highly sensitive to any
contamination sources. It lasts for several days and is extremely
expensive. Quality controls must be performed throughout the process,
especially to monitor cell growth during the expansion phase and to
detect any contaminations. Regular sampling of the bioreactor’s content
is required and subsequent biological investigation are conducted. Major
drawbacks are first, a delayed result of the quality control and
second, an added risk to induce new contaminations when sampling the
content of the bioreactor. Here, we present a real time optical
spectroscopy method which can be used in a closed system manner, hence
reducing the risk of sampling-related contamination. Analysing the shape
of the absorption spectrum of the bioreactor content allows monitoring
the cell growth and alerting users in case of contamination. Cell
concentrations are measured with an accuracy of ± 5% and contamination
can be detected about 3 hours after it occurred. This allows stopping
the fabrication as soon as a problem arises leading to several tens of
thousand dollars savings. Consequently, the price of these products
should be greatly reduced and they may be proposed to more patients.
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