A 3-year experience of quality control and quality assurance in the multisite delivery of a lymphocyte-based cellular therapy for renal cell carcinoma
| Autor: | Carla Charles, Brian Davies, Victor Liu, Letinh Ho, Jessica Stack, Yuan-Jin Shen, Gary C. du Moulin, Evelyn Conti, Judy Chew-Darke, Zorina Pitkin, Dylan Hamilton, Carolyn Cyr, Adrienne White |
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| Rok vydání: | 1994 |
| Předmět: |
Oncology
medicine.medical_specialty Adoptive cell transfer business.industry Lymphocyte medicine.medical_treatment Quality control Bioengineering Immunotherapy medicine.disease Applied Microbiology and Biotechnology Cell therapy medicine.anatomical_structure Renal cell carcinoma Internal medicine Immunology medicine business Quality assurance Cell potency Biotechnology |
| Zdroj: | Biotechnology and bioengineering. 43(8) |
| ISSN: | 0006-3592 |
| Popis: | Autolymphocyte therapy (ALT) is outpatient-based adoptive immunotherapy using ex vivo-activated memory T-cells. To support the safe and reproducible delivery of ALT at three cell processing facilities (Boston, MA; Atlanta, GA; Orange, CA) we created a comprehensive quality assurance/quality control program compliant with recent FDA guidance relevant to activated lymphocytes and somatic cell therapies. Each facility performed extensive QC testing to ensure sterility, viability, and proper cell yield. Additionally, several QC tests were performed at Cellocr's centralized reference laboratory to monitor cell potency and identity of the ex vivo-processed lymphocytes. We report here the successful implementation of this QA/QC program for ALT which has resulted in the safe preparation and delivery of cell infusion products amounting to over 3600 treatments at seven clinical sites nationwide. We believe this program will serve as a model for other cellular therapies. |
| Databáze: | OpenAIRE |
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