Hematopoietic Stem
Cell Laboratory
Hillman Research Pavilion
Lab 1.54
5117 Centre Ave
Pittsburgh, PA 15213
Contact: Linda Moore
(412) 623-1169
(412) 623-2291
moorelr@upmc.edu
Overview
The Hematopoietic Stem Cell Laboratory (HSCLab) provides production assistance for cellular therapies in a facility located on the first floor of the Hillman Cancer Center. The HSCLab has 17 years of experience in supporting the Hematopoietic Stem Cell Transplant Program, as well as serving as a production lab and reference lab for other institutions. Albert Donnenberg, PhD, has directed the HSCLab since 1997. The staff processes, cryopreserves and assists in the infusion of hematopoietic progenitor cell products and therapeutic T-cell products. The HSCLab also provides both expertise in Current Good Tissue Practice (cGTP) and assistance in translational development of novel stem cell products. In December 2002, the HSCLab moved to its current location in the newly constructed Hillman Cancer Center Research Pavilion.
HSCLab personnel
The state-of-the-art HSCLab is designed with architectural features consistent with FDA recommendations for cleanrooms and controlled environment, similar to a pharmaceutical manufacturing facility. The overall design, air quality systems and architectural finishes meet regulatory requirements and are consistent with the ability to integrate equipment and all utilities into the process of cell manufacture. Floors incorporate the installation of epoxy and epoxy terrazzo with a smooth transition between the flooring and wall panels. The building materials used withstand frequent cleaning and sanitization with approved sanitization agents. Walls and doors are smooth and cleanable and have minimal ledges and joints. Surfaces are non-shedding and non-porous. Doors incorporate interlock systems, and door operators are designed to overcome room air-pressure differentials.
The HSCLab is accredited by the Foundation for the Accreditation of Cellular Therapy (FACT), and CLIA (#39D0869846) and Pennsylvania Department of Health (#022322). It registered with the FDA per 21CFR 1271 in January 2004 (FEI# pending). HSCLab is a member of the PACT Group