Characterization of human induced pluripotent stems cells: Current approaches, challenges, and future solutions. Suresh Babu, S., Duvvuru, H., Baker, J., Switalski, S., Shafa, M., Panchalingam, K. M., Dadgar, S., Beller, J., & Ahmadian Baghbaderani, B. Biotechnol. Rep. (Amst.), 37(e00784):e00784, Elsevier BV, March, 2023. abstract bibtex Human induced pluripotent stem cells (iPSC) have demonstrated massive potentials for use in regenerative and personalized medicine due to their ability to expand in culture and differentiate into specialized cells with therapeutic benefits. However, in order to industrialize iPSC-derived therapies, it is necessary to address the existing challenges surrounding the analytics implemented in the manufacturing process to evaluate and monitor cell expansion, differentiation, and quality of the final products. Here, we review some of the key analytical methods used as part of identity, potency, or safety for in-process or final product release testing and highlighted the challenges and potential solutions for consideration in the Chemistry, Manufacturing and Controls (CMC) strategy for iPSC-based therapies. Some of the challenges associated with characterization and testing of iPSC-based products are related to the choice of analytical technology (to ensure fit-for-purpose), assay reliability and robustness. Automation of analytical methods may be required to reduce hands on time, and improve reliability of the methods through reducing assay variability. Indeed, we have shown that automation of analytical methods is feasible (evaluated using an ELISA based assay) and would result in more precise measurements (demonstrated by lower co-efficient of Variation and standard deviation), less hands-on time, and swift compared to a manually run assay. Therefore, in order to support commercialization of iPSC-based therapies we suggest a well-designed testing strategy to be established in the development phase while incorporating robust, reproducible, reliable, and potentially automated analytics in the manufacturing process.
@article{suresh23_charac,
title = "Characterization of human induced pluripotent stems cells:
Current approaches, challenges, and future solutions",
author = "Suresh Babu, Sahana and Duvvuru, Haritha and Baker, Jillian
and Switalski, Stephanie and Shafa, Mehdi and Panchalingam,
Krishna Morgan and Dadgar, Saedeh and Beller, Justin and
Ahmadian Baghbaderani, Behnam",
abstract = "Human induced pluripotent stem cells (iPSC) have demonstrated
massive potentials for use in regenerative and personalized
medicine due to their ability to expand in culture and
differentiate into specialized cells with therapeutic
benefits. However, in order to industrialize iPSC-derived
therapies, it is necessary to address the existing challenges
surrounding the analytics implemented in the manufacturing
process to evaluate and monitor cell expansion,
differentiation, and quality of the final products. Here, we
review some of the key analytical methods used as part of
identity, potency, or safety for in-process or final product
release testing and highlighted the challenges and potential
solutions for consideration in the Chemistry, Manufacturing
and Controls (CMC) strategy for iPSC-based therapies. Some of
the challenges associated with characterization and testing
of iPSC-based products are related to the choice of
analytical technology (to ensure fit-for-purpose), assay
reliability and robustness. Automation of analytical methods
may be required to reduce hands on time, and improve
reliability of the methods through reducing assay
variability. Indeed, we have shown that automation of
analytical methods is feasible (evaluated using an ELISA
based assay) and would result in more precise measurements
(demonstrated by lower co-efficient of Variation and standard
deviation), less hands-on time, and swift compared to a
manually run assay. Therefore, in order to support
commercialization of iPSC-based therapies we suggest a
well-designed testing strategy to be established in the
development phase while incorporating robust, reproducible,
reliable, and potentially automated analytics in the
manufacturing process.",
journal = "Biotechnol. Rep. (Amst.)",
publisher = "Elsevier BV",
volume = 37,
number = "e00784",
pages = "e00784",
month = mar,
year = 2023,
keywords = "Analytical methods; Assay robustness; Automation; Cell
therapies; iPSCs",
copyright = "http://creativecommons.org/licenses/by-nc-nd/4.0/",
language = "en"
}
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M.","Dadgar, S.","Beller, J.","Ahmadian Baghbaderani, B."],"bibdata":{"bibtype":"article","type":"article","title":"Characterization of human induced pluripotent stems cells: Current approaches, challenges, and future solutions","author":[{"propositions":[],"lastnames":["Suresh","Babu"],"firstnames":["Sahana"],"suffixes":[]},{"propositions":[],"lastnames":["Duvvuru"],"firstnames":["Haritha"],"suffixes":[]},{"propositions":[],"lastnames":["Baker"],"firstnames":["Jillian"],"suffixes":[]},{"propositions":[],"lastnames":["Switalski"],"firstnames":["Stephanie"],"suffixes":[]},{"propositions":[],"lastnames":["Shafa"],"firstnames":["Mehdi"],"suffixes":[]},{"propositions":[],"lastnames":["Panchalingam"],"firstnames":["Krishna","Morgan"],"suffixes":[]},{"propositions":[],"lastnames":["Dadgar"],"firstnames":["Saedeh"],"suffixes":[]},{"propositions":[],"lastnames":["Beller"],"firstnames":["Justin"],"suffixes":[]},{"propositions":[],"lastnames":["Ahmadian","Baghbaderani"],"firstnames":["Behnam"],"suffixes":[]}],"abstract":"Human induced pluripotent stem cells (iPSC) have demonstrated massive potentials for use in regenerative and personalized medicine due to their ability to expand in culture and differentiate into specialized cells with therapeutic benefits. However, in order to industrialize iPSC-derived therapies, it is necessary to address the existing challenges surrounding the analytics implemented in the manufacturing process to evaluate and monitor cell expansion, differentiation, and quality of the final products. Here, we review some of the key analytical methods used as part of identity, potency, or safety for in-process or final product release testing and highlighted the challenges and potential solutions for consideration in the Chemistry, Manufacturing and Controls (CMC) strategy for iPSC-based therapies. Some of the challenges associated with characterization and testing of iPSC-based products are related to the choice of analytical technology (to ensure fit-for-purpose), assay reliability and robustness. Automation of analytical methods may be required to reduce hands on time, and improve reliability of the methods through reducing assay variability. Indeed, we have shown that automation of analytical methods is feasible (evaluated using an ELISA based assay) and would result in more precise measurements (demonstrated by lower co-efficient of Variation and standard deviation), less hands-on time, and swift compared to a manually run assay. Therefore, in order to support commercialization of iPSC-based therapies we suggest a well-designed testing strategy to be established in the development phase while incorporating robust, reproducible, reliable, and potentially automated analytics in the manufacturing process.","journal":"Biotechnol. Rep. 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However, in order to industrialize iPSC-derived\n therapies, it is necessary to address the existing challenges\n surrounding the analytics implemented in the manufacturing\n process to evaluate and monitor cell expansion,\n differentiation, and quality of the final products. Here, we\n review some of the key analytical methods used as part of\n identity, potency, or safety for in-process or final product\n release testing and highlighted the challenges and potential\n solutions for consideration in the Chemistry, Manufacturing\n and Controls (CMC) strategy for iPSC-based therapies. Some of\n the challenges associated with characterization and testing\n of iPSC-based products are related to the choice of\n analytical technology (to ensure fit-for-purpose), assay\n reliability and robustness. Automation of analytical methods\n may be required to reduce hands on time, and improve\n reliability of the methods through reducing assay\n variability. 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