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Review
. 2018:165:323-350.
doi: 10.1007/10_2017_14.

Platforms for Manufacturing Allogeneic, Autologous and iPSC Cell Therapy Products: An Industry Perspective

Eytan Abraham  1 , Behnam Baghbaderani Ahmadian  2 , Kathryn Holderness  3 , Yonatan Levinson  3 , Erika McAfee  3
Affiliations
Review

Platforms for Manufacturing Allogeneic, Autologous and iPSC Cell Therapy Products: An Industry Perspective

Eytan Abraham et al. Adv Biochem Eng Biotechnol. 2018.

Abstract

As cell therapy processes mature from benchtop research protocols to industrial processes capable of manufacturing market-relevant numbers of doses, new cell manufacturing platforms are required. Here we give an overview of the platforms and technologies currently available to manufacture allogeneic cell products, such as mesenchymal stem cells (MSCs) and induced pluripotent stem cells (iPSCs), and technologies for mass production of autologous cell therapies via scale-out. These technologies include bioreactors, microcarriers, cell separation and cryopreservation equipment, molecular biology tools for iPSC generation, and single-use controlled-environment systems for autologous cell production. These platforms address the challenges of manufacturing cell products in greater numbers while maintaining process robustness and product quality.

Keywords: Allogeneic; Autologous; CAR-T; Cell therapy; Mesenchymal stem cells; iPSCs.

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References

    1. Rowley J, Abraham E, Campbell A, Brandwein H, Oh S (2012) Meeting lot-size challenges of manufacturing adherent cells for therapy. BioProcess Int 10:16–22
    1. Jung S, Panchalingam KM, Wuerth RD, Rosenberg L, BehieL A (2012) Large-scale production of human mesenchymal stem cells for clinical applications. Biotechnol Appl Biochem 59(2):106–1120
    1. Peiman H, Viswanathan S (2016) Bioreactor for scale-up: process control. In: Mesenchymal stromal cells: translational pathways to clinical adoption. Academic Press, London
    1. GE Healthcare/Amersham Biosciences (2005) Microcarrier cell culture: principles and methods. GE Healthcare/Amersham Biosciences, Pittsburgh
    1. Eibes G, dosSantos F, Andrade PZ, Boura JS, Abecasis MM, DaSilva CL et al (2010) Maximizing the ex vivo expansion of human mesenchymal stem cells using a microcarrier-based stirred culture system. J Biotechnol 146(4):194-197

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