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- Open Access
Xeno-free serum replacement for ex vivo culture and expansion of T cells
© Schjetne et al.; licensee BioMed Central Ltd. 2014
Published: 6 November 2014
The manufacture of a majority of clinical T cell products for immunotherapy applications requires ex vivo T cell culture and expansion. Commercialization of T cell manufacturing processes requires reagents that meet regulatory guidelines and ultimately help reduce manufacturing cost of goods. A key component in many T cell culture protocols is human serum, which is expensive and may require testing prior to use for the manufacture of a cGMP-compliant T cell product. To this end, we have developed a xeno-free serum replacement supplement with defined components that can be used in combination with several different cell culture media to support ex vivo expansion of T cells.
T cells activated ex vivo and expanded with Dynabeads® CD3/CD28 CTSTM and cultured in OpTmizer™ CTS™, X-VivoTM 15, or AIM-V® CTS™ supplemented with pooled human serum or serum free T cell serum replacement showed similar growth kinetics, total fold expansion and transduction efficiency after 2 weeks in culture. Numbers of expanded CD4+ and CD8+ T cells were comparable in the expanded cultures regardless in the presence of human serum or the newly developed SRS-XF. Restimulated T cells expanded in serum free T cell serum replacement show similar cytokine profile and proliferation as T cells expanded in human serum.
This study shows that human serum may be replaced by a xeno-free formulation in several commonly used cell culture media to support ex vivo expansion and lentiviral transduction of polyclonal T cells. Culturing T cells in serum free T cell serum replacement facilitates a favourable culture profile and immune function. The serum free T cell serum replacement contains only fully tested human-derived or human recombinant proteins which facilitates supply security for clinical large scale and commercial therapies.
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.