Polyclonal Regulatory T Cell Manufacturing Under cGMP: A Decade of Experience
Autor: | Joanna Balcerek, Brian R. Shy, Amy L. Putnam, Lisa M. Masiello, Angela Lares, Florinna Dekovic, Luis Acevedo, Michael R. Lee, Vinh Nguyen, Weihong Liu, Sreenivasan Paruthiyil, Jingying Xu, Ashley S. Leinbach, Jeffrey A. Bluestone, Qizhi Tang, Jonathan H. Esensten |
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Jazyk: | angličtina |
Rok vydání: | 2021 |
Předmět: |
Oncology
medicine.medical_specialty Regulatory T cell Cell number T-Lymphocytes Immunology Cell- and Tissue-Based Therapy Patient characteristics Phases of clinical research Treg cell T-Lymphocytes Regulatory Transplantation Autologous regulatory T cells Cell therapy Vaccine Related Patient age Internal medicine medicine regulatory T cell manufacturing Humans Immunology and Allergy Original Research Biological Products Transplantation biology business.industry cellular therapy RC581-607 ex vivo expansion Regulatory cGMP medicine.anatomical_structure Polyclonal antibodies Consumer Product Safety Medical Microbiology biology.protein Immunologic diseases. Allergy business Autologous |
Zdroj: | Frontiers in Immunology Frontiers in Immunology, Vol 12 (2021) |
ISSN: | 1664-3224 |
DOI: | 10.3389/fimmu.2021.744763 |
Popis: | We report on manufacturing outcomes for 41 autologous polyclonal regulatory T cell (PolyTreg) products for 7 different Phase 1 clinical trials over a 10-year period (2011-2020). Data on patient characteristics, manufacturing parameters, and manufacturing outcomes were collected from manufacturing batch records and entered into a secure database. Overall, 88% (36/41) of PolyTreg products met release criteria and 83% (34/41) of products were successfully infused into patients. Of the 7 not infused, 5 failed release criteria, and 2 were not infused because the patient became ineligible due to a change in clinical status. The median fold expansion over the 14-day manufacturing process was 434.8 -fold (range 29.8-2,232), resulting in a median post-expansion cell count of 1,841 x 106 (range 56.9-16,179 x 106). The main correlate of post-expansion cell number was starting cell number, which positively correlates with absolute circulating Treg cell count. Other parameters, including date of PolyTreg production, patient sex, and patient age did not significantly correlate with fold expansion of Treg during product manufacturing. In conclusion, PolyTreg manufacturing outcomes are consistent across trials and dates of production. |
Databáze: | OpenAIRE |
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