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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

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Utilization of Recombinant Albumins in the Expansion of Human T Lymphocytes

Latest Advances in CAR-T Cell Manufacture & Clinical Developments

Atherly Pennybaker & Randall Alfano

INNOVATOR INSIGHT

As novel cellular therapeutics continue to demonstrate tremendous progress in the clinic, improvements in the understanding of cell culture media components and expansion media design must continue in parallel to achieve better manufacturing process definition and control. One such critical component, human serum albumin, has been demonstrated to promote growth and viability of mammalian cells when cultured ex vivo. Several serum free cell culture media products currently marketed incorporate albumin purified from human serum. Although these media formulations, known as xeno-free, have demonstrated satisfactory expansion capability of phenotypically correct cells, there are potential safety, supply, and reproducibility issues associated with using components isolated from serum. InVitria leverages an animal component free protein expression system to produce recombinant proteins, including human serum albumin, at large scale. The recombinant human serum albumin produced in a nonmammalian-based expression technology, known as Cellastim S®, exhibited exceptional ability to support expansion of T Lymphocytes sourced from peripheral blood of healthy donors in comparison to native sourced albumins from both human and bovine serum as well as other recombinant albumins produced in yeast. Further, Cellastim S® resembled serum-derived albumin albeit more consistent profile as determined by reverse phase HPLC and mass spectrometry. Taken together, Cellastim S® is an attractive recombinant alternative for serum-derived albumin in T Lymphocyte applications.

DOI: 10.18609/cgti.2018.024
Citation: Cell Gene Therapy Insights 2018; 4(4), 231-239.
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