Automation, Monitoring, and Standardization of Cell Product Manufacturing

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.

Automation in the Life Science Research Laboratory

“…Such therapies will ultimately require the expansion of stem cells on a scale that is uneconomical for manual based laboratories, with large numbers also needed for research and clinical trials phases. The need for reliable methods of high-volume, quality-assured cells has led to the development of automated systems such as the StemCellFactory (Doulgkeroglou et al, 2020), StemCellDiscovery (Jung et al, 2018) and AUTOSTEM (Ochs et al, 2017). The objective of these systems is to automate the normally manual stages of stem cell seeding, growth, colony selection, passaging, quality assessment, harvesting and potentially in later applications differentiation.…”

Development of a bio-inkjet printed LAMP test kit for detecting human African trypanosomiasis

“…In addition, making a glassy amorphous phase for enzyme vitrification by drying procedure seems to be highly dependent upon the efficacy or speed of dehydration as observed in our experience and other reports [39,40], thus higher volume of the reagents may simply delayed the speed of dehydration and may form crystalline trehalose which deteriorate the enzyme activity. The accuracies of inkjet printer and automatic pipette are considered to be more accurate because the procedures are independent of user experience [41,42]. Indeed, three independent batches of CZC-LAMPs were tested for their sensitivities, resulting in similar performances in terms of reaction speed and sensitivity (S1 Fig).…”

Scaffold-free cell-based tissue engineering therapies: advances, shortfalls and forecast

“…In order to overcome these limitations, automated platforms could significantly reduce the cost of goods up to 30% (ref. 180 ), ensuring reliability and reproducibility across the life cycle of the product, from cell isolation and expansion to in‐line product quality assurance 181 , 182 . To further standardise the manufacturing process, the development of xeno-free, chemically defined media has been advocated to reduce the risk of pathogen sources and simplify the regulatory approval 183 , 184 .…”