Large-scale Cell Production of Stem Cells for Clinical Application Using the Automated Cell Processing Machine

Overview

Journal BMC Biotechnol

Publisher Biomed Central

Specialty Biotechnology

Date 2013 Nov 16

PMID 24228851

Citations 19

Authors

Daisuke Kami

Keizo Watakabe

Mayu Yamazaki-Inoue

Kahori Minami

Tomoya Kitani

Yoko Itakura

Masashi Toyoda

Takashi Sakurai

Akihiro Umezawa

Satoshi Gojo

Affiliations

Soon will be listed here.

Abstract

Background: Cell-based regeneration therapies have great potential for application in new areas in clinical medicine, although some obstacles still remain to be overcome for a wide range of clinical applications. One major impediment is the difficulty in large-scale production of cells of interest with reproducibility. Current protocols of cell therapy require a time-consuming and laborious manual process. To solve this problem, we focused on the robotics of an automated and high-throughput cell culture system. Automated robotic cultivation of stem or progenitor cells in clinical trials has not been reported till date. The system AutoCulture used in this study can automatically replace the culture medium, centrifuge cells, split cells, and take photographs for morphological assessment. We examined the feasibility of this system in a clinical setting.

Results: We observed similar characteristics by both the culture methods in terms of the growth rate, gene expression profile, cell surface profile by fluorescence-activated cell sorting, surface glycan profile, and genomic DNA stability. These results indicate that AutoCulture is a feasible method for the cultivation of human cells for regenerative medicine.

Conclusions: An automated cell-processing machine will play important roles in cell therapy and have widespread use from application in multicenter trials to provision of off-the-shelf cell products.

Citing Articles

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References

Liu Y, Hourd P, Chandra A, Williams D . Human cell culture process capability: a comparison of manual and automated production. J Tissue Eng Regen Med. 2009; 4(1):45-54. DOI: 10.1002/term.217. View

Koike H, Kubota K, Sekine K, Takebe T, Ouchi R, Zheng Y . Establishment of automated culture system for murine induced pluripotent stem cells. BMC Biotechnol. 2012; 12:81. PMC: 3499150. DOI: 10.1186/1472-6750-12-81. View

Terstegge S, Laufenberg I, Pochert J, Schenk S, Itskovitz-Eldor J, Endl E . Automated maintenance of embryonic stem cell cultures. Biotechnol Bioeng. 2006; 96(1):195-201. DOI: 10.1002/bit.21061. View

Ruckdeschel Smith R, Barile L, Cho H, Leppo M, Hare J, Messina E . Regenerative potential of cardiosphere-derived cells expanded from percutaneous endomyocardial biopsy specimens. Circulation. 2007; 115(7):896-908. DOI: 10.1161/CIRCULATIONAHA.106.655209. View

Unger C, Skottman H, Blomberg P, Dilber M, Hovatta O . Good manufacturing practice and clinical-grade human embryonic stem cell lines. Hum Mol Genet. 2008; 17(R1):R48-53. DOI: 10.1093/hmg/ddn079. View

Kuroda Y, Kitada M, Wakao S, Nishikawa K, Tanimura Y, Makinoshima H . Unique multipotent cells in adult human mesenchymal cell populations. Proc Natl Acad Sci U S A. 2010; 107(19):8639-43. PMC: 2889306. DOI: 10.1073/pnas.0911647107. View

Gojo S, Toyoda M, Umezawa A . Tissue engineering and cell-based therapy toward integrated strategy with artificial organs. J Artif Organs. 2011; 14(3):171-7. DOI: 10.1007/s10047-011-0578-4. View

Thomas R, Hourd P, Williams D . Application of process quality engineering techniques to improve the understanding of the in vitro processing of stem cells for therapeutic use. J Biotechnol. 2008; 136(3-4):148-55. DOI: 10.1016/j.jbiotec.2008.06.009. View

Rota M, Padin-Iruegas M, Misao Y, De Angelis A, Maestroni S, Ferreira-Martins J . Local activation or implantation of cardiac progenitor cells rescues scarred infarcted myocardium improving cardiac function. Circ Res. 2008; 103(1):107-16. PMC: 2747796. DOI: 10.1161/CIRCRESAHA.108.178525. View

10.

Burger S . Current regulatory issues in cell and tissue therapy. Cytotherapy. 2003; 5(4):289-98. DOI: 10.1080/14653240310002324. View

11.

Thomas R, Anderson D, Chandra A, Smith N, Young L, Williams D . Automated, scalable culture of human embryonic stem cells in feeder-free conditions. Biotechnol Bioeng. 2008; 102(6):1636-44. DOI: 10.1002/bit.22187. View

12.

Kino-Oka M, Ogawa N, Umegaki R, Taya M . Bioreactor design for successive culture of anchorage-dependent cells operated in an automated manner. Tissue Eng. 2005; 11(3-4):535-45. DOI: 10.1089/ten.2005.11.535. View

13.

Hubbell J, Palsson B, Papoutsakis E . Preface: Tissue engineering and cell therapies: II. Biotechnol Bioeng. 1994; 43(8):683. DOI: 10.1002/bit.260430802. View

14.

Thomas R, Chandra A, Liu Y, Hourd P, Conway P, Williams D . Manufacture of a human mesenchymal stem cell population using an automated cell culture platform. Cytotechnology. 2008; 55(1):31-9. PMC: 2289788. DOI: 10.1007/s10616-007-9091-2. View

15.

Tran C, Burton L, Russom D, Wagner J, Jensen M, Forman S . Manufacturing of large numbers of patient-specific T cells for adoptive immunotherapy: an approach to improving product safety, composition, and production capacity. J Immunother. 2007; 30(6):644-54. DOI: 10.1097/CJI.0b013e318052e1f4. View

16.

Joannides A, Fiore-Heriche C, Westmore K, Caldwell M, Compston A, Allen N . Automated mechanical passaging: a novel and efficient method for human embryonic stem cell expansion. Stem Cells. 2006; 24(2):230-5. DOI: 10.1634/stemcells.2005-0243. View

17.

Sharov A, Dudekula D, Ko M . A web-based tool for principal component and significance analysis of microarray data. Bioinformatics. 2005; 21(10):2548-9. DOI: 10.1093/bioinformatics/bti343. View

18.

Ptaszek L, Mansour M, Ruskin J, Chien K . Towards regenerative therapy for cardiac disease. Lancet. 2012; 379(9819):933-942. DOI: 10.1016/S0140-6736(12)60075-0. View

19.

Takehara N, Tsutsumi Y, Tateishi K, Ogata T, Tanaka H, Ueyama T . Controlled delivery of basic fibroblast growth factor promotes human cardiosphere-derived cell engraftment to enhance cardiac repair for chronic myocardial infarction. J Am Coll Cardiol. 2008; 52(23):1858-1865. DOI: 10.1016/j.jacc.2008.06.052. View

20.

Soncin S, Cicero V, Astori G, Soldati G, Gola M, Surder D . A practical approach for the validation of sterility, endotoxin and potency testing of bone marrow mononucleated cells used in cardiac regeneration in compliance with good manufacturing practice. J Transl Med. 2009; 7:78. PMC: 2753319. DOI: 10.1186/1479-5876-7-78. View