화학공학소재연구정보센터
Biotechnology and Bioengineering, Vol.43, No.8, 693-699, 1994
A 3-Year Experience of Quality-Control and Quality Assurance in the Multisite Delivery of a Lymphocyte-Based Cellular Therapy for Renal-Cell Carcinoma
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 Cellcor’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.