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Overcoming Challenges in Process Development of Cellular Therapies
Steven L Highfill1, David F Stroncek2
1Center for Cellular Engineering, Department of Transfusion Medicine, Clinical Center, National Institutes of Health, Bethesda, MD, USA. steven.highfill@nih.gov.
Current Hematologic Malignancy Reports
|July 7, 2019
Summary
Developing chimeric antigen receptor (CAR) T cell therapies presents unique challenges in early-stage process development. This review explores common hurdles and offers strategies for navigating CAR T cell product development and manufacturing.
Area of Science:
- Cellular therapy
- Immunotherapy
- Oncology
Background:
- Chimeric antigen receptor (CAR) T cell therapy has shown significant efficacy in treating lymphoma and leukemia.
- The success of CAR T cells is driving the development of new cellular therapies for various indications.
- Process development for cellular therapies faces unique and emerging challenges.
Purpose of the Study:
- To explore common challenges in the early phases of CAR T cell product development.
- To provide suggestions for navigating these developmental challenges.
- To highlight aspects of CAR T cell process development and clinical manufacturing.
Main Methods:
- Review of recent articles focusing on CAR T cell process development and clinical manufacturing.
- Examination of various stages of CAR T cell process development.
- Outline of obstacles in moving from pre-clinical to clinical manufacturing.
Main Results:
- CAR T cell therapy development involves unique challenges distinct from traditional pharmaceuticals.
- Overcoming obstacles in process development is crucial for advancing CAR T cell products.
- Alignment between laboratory, clinical investigators, and GMP manufacturing is essential.
Conclusions:
- Addressing early-phase development challenges is key to advancing CAR T cell therapies.
- Efficiently moving new CAR T cell products through clinical trials requires streamlined development.
- Standardized approaches facilitate comparison of clinical trial results.
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