1. Tumor-infiltrating lymphocytes: Streamlining a complex manufacturing process.
- Author
-
Hopewell EL, Cox C, Pilon-Thomas S, and Kelley LL
- Subjects
- Cell Survival, Coculture Techniques, Endotoxins analysis, Humans, Melanoma pathology, Melanoma therapy, Mycoplasma, Batch Cell Culture Techniques methods, Batch Cell Culture Techniques trends, Immunotherapy, Adoptive methods, Lymphocytes, Tumor-Infiltrating, Quality Control
- Abstract
Adoptive cell therapy of tumor-infiltrating lymphocytes has shown promise for treatment of refractory melanoma and other solid malignancies; however, challenges to manufacturing have limited its widespread use. Traditional manufacturing efforts were lengthy, cumbersome and used open culture systems. We describe changes in testing and manufacturing that decreased the process cycle time, enhanced the robustness of critical quality attribute testing and facilitated a functionally closed system. These changes have enabled export of the manufacturing process to support multi-center clinical trials., (Copyright © 2018 International Society for Cell and Gene Therapy. Published by Elsevier Inc. All rights reserved.)
- Published
- 2019
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