Approach of resource expenditure estimation toward mechanization in the manufacturing of cell-based products

Mizutani, Manabu; Nakajima, Kenichi; Kino‐oka, Masahiro

doi:10.1016/j.reth.2022.02.004

Cited by 6 publications

(2 citation statements)

References 30 publications

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“…These factors may be attributed to the psychological burden faced by CPOs due to human manual operations. Mechanization is considered in terms of cost, and it is estimated that the initial cost will be exceeded by the production of 33 or more batches of cell products per year [ 17 ]. However, the most commercially available cell products in Japan are still manufactured manually, although 200 have been sold, based on market size calculations.…”

Section: Discussionmentioning

confidence: 99%

Stress and motivation of cell processing operators: A pilot study of an online questionnaire survey

Mizuno

Sugahara

Iwayama

et al. 2022

Regenerative Therapy

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Section: Discussionmentioning

confidence: 99%

Stress and motivation of cell processing operators: A pilot study of an online questionnaire survey

Mizuno

Sugahara

Iwayama

et al. 2022

Regenerative Therapy

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“…Addressing these two fundamental questions will enable researchers to better define their requirements for in vitro tumorigenicity assessment. In addition to the manual efforts, the proper use of advanced technologies, such as automated robotics [107,108], sensitive biosensors [109,110], and machine intelligence [111][112][113], may also help the academia and industry to reach a global consensus on tumorigenicity assessment.…”

Section: Outlook and Conclusionmentioning

confidence: 99%

Assessing Tumorigenicity in Stem Cell-Derived Therapeutic Products: A Critical Step in Safeguarding Regenerative Medicine

Wang

2023

Bioengineering

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Stem cells hold promise in regenerative medicine due to their ability to proliferate and differentiate into various cell types. However, their self-renewal and multipotency also raise concerns about their tumorigenicity during and post-therapy. Indeed, multiple studies have reported the presence of stem cell-derived tumors in animal models and clinical administrations. Therefore, the assessment of tumorigenicity is crucial in evaluating the safety of stem cell-derived therapeutic products. Ideally, the assessment needs to be performed rapidly, sensitively, cost-effectively, and scalable. This article reviews various approaches for assessing tumorigenicity, including animal models, soft agar culture, PCR, flow cytometry, and microfluidics. Each method has its advantages and limitations. The selection of the assay depends on the specific needs of the study and the stage of development of the stem cell-derived therapeutic product. Combining multiple assays may provide a more comprehensive evaluation of tumorigenicity. Future developments should focus on the optimization and standardization of microfluidics-based methods, as well as the integration of multiple assays into a single platform for efficient and comprehensive evaluation of tumorigenicity.

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Noninvasive total counting of cultured cells using a home-use scanner with a pattern sheet

Mizuno,

Maeda,

Sanami

et al. 2024

iScience

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Approach of resource expenditure estimation toward mechanization in the manufacturing of cell-based products

Cited by 6 publications

References 30 publications

Stress and motivation of cell processing operators: A pilot study of an online questionnaire survey

Stress and motivation of cell processing operators: A pilot study of an online questionnaire survey

Assessing Tumorigenicity in Stem Cell-Derived Therapeutic Products: A Critical Step in Safeguarding Regenerative Medicine

Noninvasive total counting of cultured cells using a home-use scanner with a pattern sheet

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