CAGT - Clinical Research Laboratory Introduction

The Cell and Molecular Therapy Laboratory provides processing capabilities for patient and/or donor components in an environment which allows for the integration of progenitor and stem cell component preparation for transplantation, the preparation of components for adoptive immunotherapy and tumor vaccines as well as of other potentially promising approaches to transplantation and gene therapy. These labs receive cellular products from patients and/or donors and often derive many components such as gene-modified CD34+ cells, antigen presenting cells, or targeted T-cells from a single product. The challenge for laboratories such as this is to provide safe, efficient, and standardized methods for preparation for these components.

Our laboratory renders services under the FDA (Food and Drug Administration) guidelines for Good Manufacturing Practice thus assuring the quality of the materials and components produced within the facility. As reagents or supplies reach the Cell and Molecular Therapy Laboratories, they are logged into a controlled system, and all information concerning the item including lot numbers and expiration dates are tracked. They are given a unique identifying number to track each shipment individually. Items requiring Certificates of Analysis (CoAs) are quarantined until the CoAs are obtained and then stickered and released into the controlled area through the pass through after being wiped down with ethanol to minimize particulate matter and other contamination. The pass through provides a means of accessing the space without having to gown and ungown numerous times. We are in the process of developing a bar coding system to track all supplies and equipment for the laboratories. It will be incorporated into a large database that will allow tracking of all aspects of the cell and molecular therapy. We are a member of the NHLBI funded PACT group (Production Assistance for Cell Therapies) and will make clinical grade cell products without charge for investigators sponsored by PACT.http://www.pactgroup.net