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 immunotherap y using ex vivo-activated memory T-cells. To support the safe and repr oducible delivery of ALT at three cell processing facilities (Boston, MA; Atlanta, GA; Orange, CA) we created a comprehensive quality assura nce/quality control program compliant with recent FDA guidance relevan t to activated lymphocytes and somatic cell therapies. Each facility p erformed extensive QC testing to ensure sterility viability, and prope r cell yield. Additionally, several QC tests were performed at Cellcor 's centralized reference laboratory to monitor cell potency and identi ty of the ex vivo-processed lymphocytes. We report here the successful implementation of this QA/QC program for ALT which has resulted in th e safe preparation and delivery of cell infusion products amounting to over 3600 treatments at seven clinical sites nationwide. We believe t his program will serve as a model for other cellular therapies. (C) 19 94 John Wiley and Sons, Inc.