12/25/2022 0 Comments Texmacs therefore symbol![]() ![]() Among these is the need to develop robust manufacturing processes that can accommodate the complexity associated with live cell therapies in order to make products to a consistent quality. Despite this growth, cell therapy developers still face many challenges. The past few years has seen significant growth in the cell and gene therapy field with an increasing number of products receiving market authorization and approximately 900 active clinical trials ( 1). Going forward, these types of in-line sensors also open up opportunities to improve bioprocesses further through concepts such as adaptive manufacturing. This could help significantly improve cell therapy bioprocessing by allowing proactive decision-making based on real-time process data. The ability to measure these key parameters using an in-line Raman optical sensor makes it possible to have immediate feedback on process performance. ![]() Finally, using the univariate models, we also demonstrate how Raman spectroscopy can be applied for real-time monitoring. These models, which act as surrogate markers, can be used to monitor cell behavior including cell proliferation rates, proliferative capacity, and transition of the cells to a quiescent phenotype. Using a univariate modeling approach, we then show how changes in peak intensity within the Raman spectra can be correlated with cell concentration and viability. These chemometric models can accurately monitor donor-specific increases in nutrient consumption and metabolite production as the primary T-cell transition from a recovery phase and begin proliferating. Using reference datasets generated on a standard bioanalyzer, we develop chemometric models from the Raman spectra for glucose, glutamine, lactate, and ammonia. In this study, we use Raman spectroscopy as an in-line optical sensor for bioprocess monitoring of an autologous T-cell immunotherapy model produced in a stirred tank bioreactor system. Having the ability to monitor these markers in real-time using in-line sensors would offer significant advantages, allowing faster decision-making and a finer level of process control. Many processes already incorporate the measurement of key markers such as nutrient consumption, metabolite production, and cell concentration, but these are often performed off-line and only at set time points in the process. ![]() As we start to see more of these therapies gaining market authorization, attention is turning to the bioprocesses used for their manufacture, in particular the challenge of gaining higher levels of process control to help regulate cell behavior, manage process variability, and deliver product of a consistent quality. Cell and Gene Therapy Catapult, London, United KingdomĬell therapies offer unquestionable promises for the treatment, and in some cases even the cure, of complex diseases. ![]()
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