Affiliation:
1. Fraunhofer Institute for Cell Therapy and Immunology
2. Lonza (United States)
Abstract
Abstract
Process development for transferring lab-scale research workflows to automated manufacturing procedures is critical chimeric antigen receptor (CAR)-T cell therapies. Thereby, the key factor for cell viability, expansion, modification, and functionality is the optimal combination of medium and T cell activator as well as their regulatory compliance for later manufacturing under Good Manufacturing Practice (GMP). In this study, we compared two protocols for CAR-mRNA-modified T cell generation using our current lab-scale process, analyzed all mentioned parameters, and evaluated the protocols’ potential for upscaling and process development of mRNA-based CAR-T cell therapies.
Publisher
Research Square Platform LLC
Reference30 articles.
1. Impact of Manufacturing Procedures on CAR T Cell Functionality;Watanabe N;Frontiers in immunology,2022
2. CAR-T-Zellen: Update 2019;Dluczek S;Transfusionsmedizin,2019
3. Miliotou, A. N. & Papadopoulou, L. C. In Vitro-Transcribed (IVT)-mRNA CAR Therapy Development. Methods in molecular biology (Clifton, N.J.) 2086, 87–117; 10.1007/978-1-0716-0146-4_7 (2020).
4. NIH U.S. National Library of Medicine. ClinicalTrials.gov. NCT02623582. Available at https://clinicaltrials.gov/ct2/show/NCT02623582?term=NCT02623582&draw=2&rank=1.
5. NIH U.S. National Library of Medicine. ClinicalTrials.gov. NCT01897415. Available at https://clinicaltrials.gov/ct2/show/record/NCT01897415?term=NCT01897415&draw=2&rank=1.