Abstracts of the 29th Annual Scientific Meeting of the Society for Immunotherapy of Cancer (SITC)
- Poster presentation
- Open Access
Towards automated manufacturing of clinical scale gene-modified T cells
Journal for ImmunoTherapy of Cancer volume 2, Article number: P21 (2014)
Adoptive immunotherapy using gene-modified T cells redirected against cancer has proven clinical efficacy and tremendous potential in several medical fields. However, such personalized medicine faces several challenges in the complexity associated with the current clinical manufacturing methods, which hampers dissemination.
Conventionally, the preparation of autologous gene-modified T cells comprises many (open) handling steps, is labor intensive and is not adapted to treat large numbers of patients or for commercial manufacturing. Moreover, the cell-manufacturing process requires extensive training of personnel as well as a dedicated infrastructure, which restricts these clinical procedures to very few institutions worldwide. In order to face these challenges, Miltenyi Biotec has dedicated large efforts to further enable automation of cell manufacturing by developing a unique cell processing platform, the CliniMACS® Prodigy, which enables the automated manufacturing of clinical grade gene-modified T cells in a closed single-use tubing set.
Starting from leukapheresis or whole blood products, the automated process enables magnetic labeling and enrichment of T cells, their subsequent stimulation, gene-modification with lentiviral vectors, expansion and final formulation with minimal user interaction. Within the process a novel stimulatory reagent has been implemented: MACS GMP TransAct™ in combination with TexMACS GMP Medium. TransAct is a colloidal reagent developed for polyclonal T cell stimulation that is soluble and can be removed by washing. The reagent is biodegradable, sterile filtered, and suitable for potent T cell activation, gene-modification, and expansion. Clinically relevant numbers of functional gene-modified T cells (>109) have been generated within 10-14 days using the automated manufacturing process.
The flexibility and ease-of-use associated with this device and the developed process for clinical scale production of engineered T cells creates a solution for the treatment of large patient groups and facilitates economic commercial-scale manufacturing.
Rights and permissions
Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made.
The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder.
To view a copy of this licence, visit https://creativecommons.org/licenses/by/4.0/.
The Creative Commons Public Domain Dedication waiver (https://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
About this article
Cite this article
Drechsel, K., Mauer, D., Mockel-Tenbrinck, N. et al. Towards automated manufacturing of clinical scale gene-modified T cells. j. immunotherapy cancer 2 (Suppl 3), P21 (2014). https://doi.org/10.1186/2051-1426-2-S3-P21
- Clinical Grade
- Clinical Scale
- Adoptive Immunotherapy
- Cell Manufacturing
- Automate Manufacturing