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Successful Scale-Up and Quality Assessments of Human Embryonic Stem Cells for Cell Therapy: Challenges and Overview

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Adult and Embryonic Stem Cells

Part of the book series: Stem Cell Biology and Regenerative Medicine ((STEMCELL))

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Abstract

Large-scale production of human embryonic stem cells (hESCs) is the most inevitable choice to fulfill biomedical research needs to produce mature, functional, and pure derivatives of cell types that can be utilized for transplantation purposes or in drug discovery. Currently, the status of technology suggests that large-scale culturing of hESCs is complex, and several challenges must be addressed. There is a great need for convenient, inexpensive culture systems that can facilitate the propagation of hESCs in serum-free and feeder-free culture conditions, so the cells produced in large scale can meet the demands of cell therapy applications and in screening purposes for toxicology, pharmacology, and drug discovery. As a parallel effort it is equally important to assess the quality of hESCs obtained in this scaled-up procedure and develop a reliable cost-effective method to qualify the cells that can be used for various downstream purposes. In this chapter, we describe various methods used to culture hESCs in large scale and other advances in eliminating xenogenic components from the culture systems.

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Acknowledgments

MCV acknowledges the stimulating discussions and the encouragement from Dr. Mahendra Rao currently at NIH, who was responsible for persuading to write this article. MCV is also indebted to Sandra Kuligowski and Maureen Cook at Grand Island, NY for enabling deep insights in to the GMP process and Quality Control systems in cell and media manufacturing.

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Authors and Affiliations

  1. Life Technologies, 7335, Executive Way, Frederick, MD, 21704, USA

    Mohan C. Vemuri & Jasmeet Kaur

  2. Primary and Stem Cells Systems, Invitrogren BioServices India Pvt. Ltd., First Technology Place, 3EPIP, Whitefield, Bangalore, 560 066, India

    Geetha M. Swamilingiah, Shruthi Pal & Udaykumar Kolkundkar

  3. Research & Development, Primary and Stem Cell Systems, 7335 Executive Way, Frederick, MD, 21704, USA

    Geetha M. Swamilingiah, Shruthi Pal & Udaykumar Kolkundkar

Authors
  1. Mohan C. Vemuri
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  2. Geetha M. Swamilingiah
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  3. Shruthi Pal
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  4. Jasmeet Kaur
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  5. Udaykumar Kolkundkar
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Corresponding author

Correspondence to Mohan C. Vemuri .

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  1. Smyth Rd 501, Ottawa, K1H 8L6, Canada

    Kursad Turksen

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Vemuri, M.C., Swamilingiah, G.M., Pal, S., Kaur, J., Kolkundkar, U. (2012). Successful Scale-Up and Quality Assessments of Human Embryonic Stem Cells for Cell Therapy: Challenges and Overview. In: Turksen, K. (eds) Adult and Embryonic Stem Cells. Stem Cell Biology and Regenerative Medicine. Humana Press. https://doi.org/10.1007/978-1-61779-630-2_11

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