Compassionate and Emergency Use Cellular Therapy Products: Regulatory, Operational, and Quality Considerations
Authors:
- Garrett S. BoothGBGarrett S. Booth
- Ron RamRRRon Ram
- Jeremy W. JacobsJJJeremy W. Jacobs
- Bipin N. SavaniBSBipin N. Savani
- Eric A. GehrieEGEric A. Gehrie
- Joseph (Yossi) SchwartzJSJoseph (Yossi) Schwartz
- Yvette C. TanhehcoYTYvette C. Tanhehco
Open Access
- 7 November 2026
- journal article
- Published by Elsevier in Cytotherapy
Abstract
No abstract availableThis publication has 17 references indexed in Scilit:
- A call to action: Position papers from the FDA Cell Therapy Liaison Meeting (CTLM) Working GroupCytotherapy, 2026
- Sustainable Point-of-Care Manufacturing of Cell and Gene Therapies: Operational, Regulatory and Economic Pathways for ImplementationCytotherapy, 2026
- Out of Specification frameworks may overestimate clinical risk: a lesson from commercial CAR-T products deviationsCytotherapy, 2026
- PREPARATION OF A DRUG MASTER FILE FOR A CELL THERAPY PRODUCT TO SIMPLIFY ACADEMIC INVESTIGATIONAL NEW DRUG APPLICATIONSCytotherapy, 2026
- Barriers to Effective Cryopreservation of Cell Therapies: Challenges and Emerging Solution2025
- From cold chain to ambient: Benefits, risks, and evidence across cell therapy logisticsMolecular Therapy - Methods & Clinical Development, 2025
- CAR-T cell manufacturing failures and out-of-specification products in the real-world setting: A survey from the EBMT cellular therapy and immunobiology working partyBone Marrow Transplantation, 2025
- Environmental monitoring of current good manufacturing practices cleanroom facilities for manufacturing of cellular therapy products in an academic hospital settingCytotherapy, 2024
- Standardization of cellular therapy terminology, coding and labeling: a reviewCytotherapy, 2022
- Off the shelf cellular therapeutics: Factors to consider during cryopreservation and storage of human cells for clinical useCytotherapy, 2016