Strategies for scalable manufacturing and translation of MSC-derived extracellular vesicles

Stem Cell Research

Tabassum Ahsan¹  Kelvin Ng²  Divya Patel³  Jon Rowley³  Katrina Adlerz³ 

[1] Corresponding authors at: Bioprocessing Technology Institute, 20 Biopolis Way, Centros 06-01 138668, Singapore (Kelvin. Ng). RoosterBio, Inc., 5295 Westview Drive, Suite 275, Frederick, MD, 21703, USA (Tabassum. Ahsan).;Bioprocessing Technology Institute, 20 Biopolis Way, Centros 06-01 138668, Singapore;RoosterBio, Inc. 5295 Westview Drive, Suite 275, Frederick, MD 21703, USA;

关键词: MSCs;    Extracellular vesicles;    Manufacturing;    Scalability;    Regenerative medicine;   

DOI  :  

来源: DOAJ

【 摘 要 】

Mesenchymal Stem/Stromal Cells (MSCs) are a well-studied cellular therapy with many clinical trials over the last few decades to treat a range of therapeutic indications. Recently, extracellular vesicles secreted by MSCs (MSC-EVs) have been shown to recapitulate many of the therapeutic effects of the MSCs themselves. While research in MSC-EVs has exploded, it is still early in their development towards a clinical therapy. One of the main challenges in cellular therapy, which will clearly also be a challenge in MSC-EV manufacturing, is developing a scalable, cGMP-compatible manufacturing paradigm. Therefore, the focus of this review is to identify some key MSC-EV manufacturing considerations such as the selection of critical raw materials, manufacturing platforms, and critical quality attribute assays. Addressing these issues early in research and development will accelerate clinical product development, clinical trials, and commercial therapies of MSC-EVs.

【 授权许可】

Unknown