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Contrast Media & Molecular Imaging
Volume 2017, Article ID 9548478, 7 pages
https://doi.org/10.1155/2017/9548478
Research Article

Integrating a 19F MRI Tracer Agent into the Clinical Scale Manufacturing of a T-Cell Immunotherapy

1Celsense Inc., 603 Stanwix Street Suite 390, Pittsburgh, PA 15222, USA
2GE Healthcare, 100 Results Way, Marlborough, MA 01752, USA
3GE Healthcare, The Grove Center, White Lion Road, Amersham, Buckinghamshire HP7 9LL, UK

Correspondence should be addressed to Brooke M. Helfer; moc.esneslec@ekoorb

Received 10 July 2017; Revised 19 September 2017; Accepted 2 October 2017; Published 2 November 2017

Academic Editor: Anne Roivainen

Copyright © 2017 Charles F. O’Hanlon et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Leukocyte immunotherapies have made great progress in the treatment of cancer. Recent reports on the treatment of B-cell malignancies using Chimeric Antigen Receptor and affinity enhanced T-Cell Receptor therapies have demonstrated encouraging clinical results. As investigators begin to explore the treatment of solid tumors with these cells, the hurdle of evaluating T-cell homing to and persistence at the site of disease remain. Significant challenges regarding the GMP manufacture and administration of a therapeutic dose of millions to billions of transduced T-cells remain. Here we report on the application of a clinically authorized 19F MRI tracer agent to human T-cells, employing state-of-the-art methods and equipment in the manufacture of a cellular therapy. Using a general T-cell expansion protocol and clinical scale industrial bioreactors, we show 19F labeling without detriment to the product +/− cryopreservation. While the incorporation of the 19F tracer is not trivial, it is just one of the many steps that can aid in progression of a therapeutic to and though the clinic. Combining the MRI tracking capabilities, safety profiles, and clinical sensitivity of this method, this application demonstrates the ability of 19F MRI to be used in industrial scale applications to visualize the spatial fate of cellular therapeutics.