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

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

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

Afiliação

Lee B; PBS Biotech, Inc., Camarillo, CA 93012, USA.
Jung S; PBS Biotech, Inc., Camarillo, CA 93012, USA.
Hashimura Y; PBS Biotech, Inc., Camarillo, CA 93012, USA.
Lee M; PBS Biotech, Inc., Camarillo, CA 93012, USA.
Borys BS; PBS Biotech, Inc., Camarillo, CA 93012, USA.
Dang T; Department of Biomedical Engineering, Schulich School of Engineering, University of Calgary, 2500 University Dr. NW, Calgary, AB T2N 1N4, Canada.
Kallos MS; Department of Biomedical Engineering, Schulich School of Engineering, University of Calgary, 2500 University Dr. NW, Calgary, AB T2N 1N4, Canada.
Rodrigues CAV; Department of Biomedical Engineering, Schulich School of Engineering, University of Calgary, 2500 University Dr. NW, Calgary, AB T2N 1N4, Canada.
Silva TP; iBB-Institute for Bioengineering and Biosciences and Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, 1049-001 Lisboa, Portugal.
Cabral JMS; iBB-Institute for Bioengineering and Biosciences and Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, 1049-001 Lisboa, Portugal.

Bioengineering (Basel) ; 9(3)2022 Feb 25.

Article em En | MEDLINE | ID: mdl-35324781

ABSTRACT

ABSTRACT

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.

Palavras-chave

allogeneic cell therapy; cell aggregate; computational fluid dynamics; differentiation; expansion; homogeneous hydrodynamic environment; human embryonic stem cell; induced pluripotent stem cell; medium exchange; oxygenation; scalable manufacturing; scale up; shear stress; single-use bioreactor; turbulent energy dissipation rate; vertical-wheel

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Revista: Bioengineering (Basel) Ano de publicação: 2022 Tipo de documento: Article

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Revista: Bioengineering (Basel) Ano de publicação: 2022 Tipo de documento: Article