Introducing Volume 13 of
            <i>Regenerative Medicine</i>

Price-Evans, Adam

doi:10.2217/rme-2017-0149

Cited by 2 publications

(2 citation statements)

References 9 publications

(9 reference statements)

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“…While XF MSC-microcarrier cultures have been developed, it typically involves full or partial media exchanges to manage nutrient supply and waste build-up [ 25 , 26 , 27 , 28 , 29 ]. Borrowing from best practices in the monoclonal antibody field, fed batch processes can lead to high media productivity [ 30 ], as defined in the Glossary for Cell & Gene Therapy and Regenerative Medicine as millions of cells/liter of media consumed [ 31 ]. Optimizing this media productivity is critical as media is the major cost driver in cell manufacturing [ 30 ], which also carries the hidden costs of labor associated with media exchange.…”

Section: Introductionmentioning

confidence: 99%

Bioreactor Parameters for Microcarrier-Based Human MSC Expansion under Xeno-Free Conditions in a Vertical-Wheel System

Lembong¹,

Kirian²,

Takacs³

et al. 2020

Bioengineering

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Human mesenchymal stem/stromal cells (hMSCs) have been investigated and proven to be a well-tolerated, safe therapy for a variety of indications, as shown by over 900 registered hMSC-based clinical trials. To meet the commercial demand for clinical manufacturing of hMSCs, production requires a scale that can achieve a lot size of ~100B cells, which requires innovative manufacturing technologies such as 3D bioreactors. A robust suspension bioreactor process that can be scaled-up to the relevant scale is therefore crucial. In this study, we developed a fed-batch, microcarrier-based bioreactor process, which enhances media productivity and drives a cost-effective and less labor-intensive hMSC expansion process. We determined parameter settings for various stages of the culture: inoculation, bioreactor culture, and harvest. Addition of a bioreactor feed, using a fed-batch approach, was necessary to replenish the mitogenic factors that were depleted from the media within the first 3 days of culture. Our study resulted in an optimized hMSC culture protocol that consistently achieved hMSC densities between 2 × 105–6 × 105 cells/mL within 5 days with no media exchange, maintaining the final cell population doubling level (PDL) at 16–20. Using multiple hMSC donors, we showed that this process was robust and yielded hMSCs that maintained expansion, phenotypic characteristic, and functional properties. The developed process in a vertical-wheel suspension bioreactor can be scaled to the levels needed to meet commercial demand of hMSCs.

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Section: Introductionmentioning

confidence: 99%

Bioreactor Parameters for Microcarrier-Based Human MSC Expansion under Xeno-Free Conditions in a Vertical-Wheel System

Lembong¹,

Kirian²,

Takacs³

et al. 2020

Bioengineering

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show abstract

“…In 2018, we have seen a significant rise in the proportion of our readership coming out of Asia compared with last year, which is indicative of the field's growth in this area [15]. While our content continues to have impact across Europe and North America, we expect to see a continued growth in emerging scientific communities and look forward to continuing the circulation of our content to an increasingly global audience.…”

Section: Readership Demographicsmentioning

confidence: 99%

Introducing Volume 14 of Regenerative Medicine

Price-Evans

2018

Regen. Med.

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Introducing Volume 13 of Regenerative Medicine

Cited by 2 publications

References 9 publications

Bioreactor Parameters for Microcarrier-Based Human MSC Expansion under Xeno-Free Conditions in a Vertical-Wheel System

Bioreactor Parameters for Microcarrier-Based Human MSC Expansion under Xeno-Free Conditions in a Vertical-Wheel System

Introducing Volume 14 of Regenerative Medicine

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