异基因多能干细胞产品商业化规模生产的细胞培养工艺放大挑战

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

作者信息

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

机构信息

PBS Biotech, Inc., Camarillo, CA 93012, USA.

Department of Biomedical Engineering, Schulich School of Engineering, University of Calgary, 2500 University Dr. NW, Calgary, AB T2N 1N4, Canada.

出版信息

Bioengineering (Basel). 2022 Feb 25;9(3):92. doi: 10.3390/bioengineering9030092.

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.