Authors:
B. Wacogne
1
;
2
;
D. Legrand
1
;
C. Pieralli
1
and
A. Frelet-Barrand
1
Affiliations:
1
FEMTO-ST institute, Univ. Bourgogne Franche-Comte, CNRS, 15B avenue des Montboucons, 25030 Besancon, cedex, France
;
2
Centre Hospitalier Universitaire de Besançon, Centre d’Investigation Clinique, INSERM CIC 1431, 25000, Besançon, France
Keyword(s):
Optical Spectroscopy, Advanced Therapy Medicinal Product, Cell Growth Monitoring, Contamination Detection.
Abstract:
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 measu
red 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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