Manufacturing with pluripotent stem cells (PSConf 2021): Key issues for future research and development

Abstract

Human pluripotent stem cells (hPSC) have the capability to deliver novel cell‐based medicines that could transform medical treatments for a wide range of diseases including age‐related degenerative disorders and traumatic injury. In spite of significant investment in this area, due to the novel nature of these hPSC‐based medicines, there are challenges in almost all aspects of their manufacturing including bioprocessing, characterization and delivery. The Chinese Academy of Sciences and the Chinese Society for Stem Cell Research have collaborated to create a new discussion forum called PSConf 2021 (Pluripotent Stem Cell Conference 2021), intended to promote exchanges in communication on cutting‐edge developments and international coordination in hPSC manufacturing. The PSConf 2021 addressed crucial topics in stem cell‐based manufacturing, including stem cell differentiation, culture scale‐up, product formulation and release. This report summarizes the proceedings and conclusions from the discussion sessions, and it is accompanied by publication of individual papers from the speakers at the PSConf 2021. Significance Statement The PSConf 2021 meeting has brought together speakers and delegates from more than 20 countries in an informal discussion forum focusing on the manufacture of cell‐based medicines using hPSCs. The conference discussion sessions enabled an open exchange of information on the latest developments, ideas on key challenges and their potential solutions. It also captured the experiences and lessons learnt by professionals who had been in the field from the earliest applications of human embryonic stem cells, and presented a diverse range of new potential pluripotent stem cell‐based medicines that are now under development, with some already in clinical trials.

Vascularized organ bioprinting: From strategy to paradigm

“…In particular, induced pluripotent stem cells 50 or clinical‐grade embryonic stem cells 51 can serve as inks or sources of inks to solve the problem of clinical patient genetic matching. Stem cells, with their capacity for growth and potential for guided differentiation, compared to the limited capacity of mature somatic cells, are predicted to address the cell quantity issue at the root 52 …”

“…Stem cells, with their capacity for growth and potential for guided differentiation, compared to the limited capacity of mature somatic cells, are predicted to address the cell quantity issue at the root. 52…”

Quantitative Proteomics for the Development and Manufacturing of Human-Induced Pluripotent Stem Cell-Derived Neural Stem Cells Using Data-Independent Acquisition Mass Spectrometry

“… 19 For using these iPS cell-derived products in the clinic, it is essential to evaluate and monitor the manufacturing process and quality of the final products. Currently, the iPS cell-derived products are evaluated based on their cell morphology, physiological function, and expression of molecular markers; 20 however, there are several issues regarding the specificity, reproducibility, and operability of these methods.…”