Scalable manufacturing

Scalable manufacturing

   

    Mesenchymal stem cells (MSC) are multipotent cells with regenerative, multidifferentiation, and immunomodulatory capacities. Expanding MSC for clinical purposes usually requires large cell dose, which demanding efficient cultivation platforms.

 

    Conventional in vitro cell expansion is conducted in static planar culture system. Less efficient space utilization constrains the scale of cell expansion. These limitations impel MSC manufacturing toward three-dimensional culture systems operating under dynamic conditions providing an economic model in respect of consumables, labor, quality controls and facility costs.

 

    The collaboration work of AventaCell and academic institutions have been successfully utilizing human platelet lysate (hPL) to expand MSC in multiple bioreactor systems (de Sure et al., 2017; A. Mizukami de al., 2018; de Sousa Pinto et al., 2019). It demonstrated applicability of hPL for scale-up MSC production in terms of maintaining cell reproducibility, stability and quality.

 

References:

1. Scalable Manufacturing of Human Mesenchymal Stromal Cells in the Vertical-Wheel Bioreactor System: An Experimental and Economic Approach.

de Sousa Pinto D, Bandeiras C, de Almeida Fuzeta M, Rodrigues CAV, Jung S, Hashimura Y, Tseng RJ, Milligan W, Lee B, Ferreira FC, Lobato da Silva C, Cabral JMS. Biotechnol J. 2019 Aug;14(8):e1800716. doi: 10.1002/biot.201800716

 

2. A fully-closed and automated hollow fiber bioreactor for clinical-grade manufacturing of human mesenchymal stem/stromal cells.

Amanda Mizukami, Mario Soares de Abreu Neto, Francisco Moreira, Ana Fernandes-Platzgummer, Yi-Feng Huang, William Milligan,Joaquim M. S. Cabral, Claudia L. da Silva, Dimas T. Covas, Kamilla Swiech. Stem Cell Rev. 2018;14(1):141-143. doi: 10.1007/s12015-017-9787-4.

 

3. Transplantation routes affect the efficacy of human umbilical cord mesenchymal stem cells in a rat GDM model.

Dan Wu, Shan Zou, Haibin Chen, Xiaoyan Li, Yetao Xu, Qing Zuo, Yi Pan, Shi-Wen Jiang, Hung Huang Lizhou Sun. Clin Chim Acta. 2017;475:137-146. doi: 10.1016/j.cca.2017.10.013.