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Deprecated: Implicit conversion from float 245.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Mol+Ther+Methods+Clin+Dev 2018 ; 9 (ä): 376-89 Nephropedia Template TP
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An Integrated Approach toward the Biomanufacturing of Engineered Cell Therapy Products in a Stirred-Suspension Bioreactor #MMPMID30038941
Hsu CY; Walsh T; Borys BS; Kallos MS; Rancourt DE
Mol Ther Methods Clin Dev 2018[Jun]; 9 (ä): 376-89 PMID30038941show ga
Recent advances in stem cell biology have accelerated the pre-clinical development of cell-based therapies for degenerative and chronic diseases. The success of this growing area hinges upon the concomitant development of scalable manufacturing platforms that can produce clinically relevant quantities of cells for thousands of patients. Current biomanufacturing practices for cell therapy products are built on a model previously optimized for biologics, wherein stable cell lines are established first, followed by large-scale production in the bioreactor. This ?two-step? approach can be costly, labor-intensive, and time-consuming, particularly for cell therapy products that must be individually sourced from patients or compatible donors. In this report, we describe a ?one-step? integrated approach toward the biomanufacturing of engineered cell therapy products by direct transfection of primary human fibroblast in a continuous stirred-suspension bioreactor. We optimized the transfection efficiency by testing rate-limiting factors, including cell seeding density, agitation rate, oxygen saturation, microcarrier type, and serum concentration. By combining the genetic modification step with the large-scale expansion step, this not only removes the need for manual handing of cells in planar culture dishes, but also enables the biomanufacturing process to be streamlined and automated in one fully enclosed bioreactor.