(July 2013) – At the DRI, our research strategy focuses on bringing promising findings from the lab to patients in the fastest, safest and most efficient way possible. Our ability to translate new therapies to clinical application is significantly enhanced by having our own human cell and tissue processing facility, called a cGMP facility, right within the DRI building.
cGMP refers to the Current Good Manufacturing Practice regulations and standard operating procedures (SOPs) enforced by the Food and Drug Administration (FDA) for proper design, monitoring and control of manufacturing processes. In addition to being FDA compliant, the DRI’s cGMP has also earned accreditation by both FACT (Foundation for the Accreditation of Cellular Therapies) and AABB, two of the most prestigious accreditation organizations in the world. The DRI was one of the first cGMP-compliant facilities in an academic setting and is currently one of only four such facilities that have been AABB and FACT accredited.
The cGMP provides DRI researchers with the highest level of control over the quality and safety of all cell products to be used in research, and most importantly for clinical use, like for the DRI BioHub and other patient studies. It also eliminates the need to wait for cells and tissues to arrive from other sources, minimizing any delays for patients.
In addition to using these biological products for its own research, the DRI processes a wide variety of cell and bone marrow-based products for other investigators and companies in South Florida and throughout the country. According to Elina Linetsky, Ph.D., DRI’s director of quality assurance and regulatory affairs, the accreditation distinguishes the Institute from other cell processing centers.
“In order to be accredited by both FACT and AABB, we need to meet their standards, which are stricter than the FDA. The accreditation improves the way we function and produce our products, which also gives us credibility with other researchers with whom we work. More and more often I get asked by investigators about our accreditation when they prepare their regulatory submissions. I think it is very beneficial to us,” said Dr. Linetsky, who was recently asked by FACT to serve as one of their inspectors and interviewed for an article in the April 2013 issue of their newsletter, Telegraft.
“The accreditations by both FACT and AABB demonstrate DRI’s committed to the highest standards of quality and excellence for patients as we move cellular therapies and biological replacement strategies for the cure of diabetes to our final goal,” said DRI Scientific Director Camillo Ricordi, M.D.
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Lori Weintraub, APR