Cell Culture Process Scale-Up Challenges for Commercial-Scale Manufacturing of Allogeneic Pluripotent Stem Cell Products

Brian Lee; Sunghoon Jung; Yas Hashimura; Maximilian Lee; Breanna S. Borys; Tiffany Dang; Michael S. Kallos; Carlos A. V. Rodrigues; Teresa P. Silva; Joaquim M. S. Cabral

doi:10.3390/bioengineering9030092

Bioengineering (Feb 2022)

Cell Culture Process Scale-Up Challenges for Commercial-Scale Manufacturing of Allogeneic Pluripotent Stem Cell Products

Brian Lee,
Sunghoon Jung,
Yas Hashimura,
Maximilian Lee,
Breanna S. Borys,
Tiffany Dang,
Michael S. Kallos,
Carlos A. V. Rodrigues,
Teresa P. Silva,
Joaquim M. S. Cabral

Affiliations

Brian Lee: PBS Biotech, Inc., Camarillo, CA 93012, USA
Sunghoon Jung: PBS Biotech, Inc., Camarillo, CA 93012, USA
Yas Hashimura: PBS Biotech, Inc., Camarillo, CA 93012, USA
Maximilian Lee: PBS Biotech, Inc., Camarillo, CA 93012, USA
Breanna S. Borys: PBS Biotech, Inc., Camarillo, CA 93012, USA
Tiffany Dang: Department of Biomedical Engineering, Schulich School of Engineering, University of Calgary, 2500 University Dr. NW, Calgary, AB T2N 1N4, Canada
Michael S. Kallos: Department of Biomedical Engineering, Schulich School of Engineering, University of Calgary, 2500 University Dr. NW, Calgary, AB T2N 1N4, Canada
Carlos A. V. Rodrigues: iBB–Institute for Bioengineering and Biosciences and Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, 1049-001 Lisboa, Portugal
Teresa P. Silva: iBB–Institute for Bioengineering and Biosciences and Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, 1049-001 Lisboa, Portugal
Joaquim M. S. Cabral: iBB–Institute for Bioengineering and Biosciences and Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, 1049-001 Lisboa, Portugal

DOI: https://doi.org/10.3390/bioengineering9030092
Journal volume & issue: Vol. 9, no. 3
p. 92

Abstract

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Allogeneic cell therapy products, such as therapeutic cells derived from pluripotent stem cells (PSCs), have amazing potential to treat a wide variety of diseases and vast numbers of patients globally. However, there are various challenges related to manufacturing PSCs in single-use bioreactors, particularly at larger volumetric scales. This manuscript addresses these challenges and presents potential solutions to alleviate the anticipated bottlenecks for commercial-scale manufacturing of high-quality therapeutic cells derived from PSCs.

Published in Bioengineering

ISSN: 2306-5354 (Online)
Publisher: MDPI AG
Country of publisher: Switzerland
LCC subjects: Technology; Science: Biology (General)
Website: https://www.mdpi.com/journal/bioengineering

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