Abstract
Although regenerative medicine products are at the forefront of scientific research, technological innovation, and clinical translation, their reproducibility and large-scale production are compromised by automation, monitoring, and standardization issues. To overcome these limitations, new technologies at software (e.g., algorithms and artificial intelligence models, combined with imaging software and machine learning techniques) and hardware (e.g., automated liquid handling, automated cell expansion bioreactor systems, automated colony-forming unit counting and characterization units, and scalable cell culture plates) level are under intense investigation. Automation, monitoring and standardization should be considered at the early stages of the developmental cycle of cell products to deliver more robust and effective therapies and treatment plans to the bedside, reducing healthcare expenditure and improving services and patient care.
Highlights
Cell and cell-based tissue engineering products have an extraordinary clinical potential by offering unique therapeutic solutions to disease conditions without any effective treatments yet, such as non-curable cancers or non-healing or hard to heal tissues (Perez et al, 2018; Abreu et al, 2019)
It is still challenging to translate labor-intense academicbased discoveries to automatedly manufactured industrial products
The prolonged culture times required to develop a cellbased tissue engineering implantable device are associated with cell phenotypic drift and high manufacturing costs (Cigognini et al, 2013; Schrock et al, 2017; Vormittag et al, 2018)
Summary
Cell and cell-based tissue engineering products have an extraordinary clinical potential by offering unique therapeutic solutions to disease conditions without any effective treatments yet, such as non-curable cancers or non-healing or hard to heal tissues (Perez et al, 2018; Abreu et al, 2019). As cell-based therapies are maturing, it is imperative to standardize and control manufacturing engineering strategies and implement robust automation and process monitoring and control for safety (above all), consistency and reproducibility purposes (Ball et al, 2018; Hunsberger et al, 2018; Pigeau et al, 2018; Moutsatsou et al, 2019). This manuscript will describe some real-life indicative examples of automation and monitoring designed to address manufacturing issues in cell-based therapies domain
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