Roswell Park Launches Landmark Immunotherapy Vaccine Trial
Roswell Park Cancer Institute announced today they have received approval from the FDA to launch a unique clinical trial. Please read the below excerpts from the press release.
Tuesday, January 24, 2012 - Developed at RPCI (Roswell Park Cancer Institute), the NY-ESO-1 dendritic cell vaccine will be manufactured in the Institute’s new Therapeutic Cell Production Facility using a unique FDA-approved process — making RPCI the first research facility in the U.S. to use a custom-made barrier isolator for vaccine cell production, and the first in the world to use this system in an approved, government-regulated study.
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The NY-ESO-1 vaccine, tailor-made for each patient, will be produced in RPCI’s Therapeutic Cell Production Facility (TCPF) under the direction of Yeong “Christopher” Choi, PhD, who notes: “We believe that our facility’s custom-made barrier isolator, the unit in which the vaccines are manufactured, is the first of its kind.” The barrier isolator — an Xvivo System processing chamber designed to RPCI’s specifications by BioSpherix, Ltd., Lacona, NY — maintains strict control of the unit’s temperature and atmospheric gases, critical for optimal production of dendritic cell vaccines.
“Those conditions, and the sterile vaccine-manufacturing environment, are rigidly maintained throughout the entire process,” says Dr. Choi. “The Xvivo — which at about 70 square feet is basically a clean room in a box — acts as a physical barrier that protects the cell-therapy product from outside contaminants, resulting in a safer, more predictable manufacturing process.”
Learn More About Xvivo System... A Cleanroom Alternative >>
Watch Roswell Press Confrence and Read Press Release >>
Cell Therapy Isolator Video >>
To learn more about the clinical research studies of the NY-ESO-1 dendritic cell vaccine, call 1-877-ASK-RPCI (1-877-275-7724).
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