Current Good Manufacturing Practices Facility
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Good Manufacturing Practices Facility

In this Health Canada-regulated facility, research teams are making new biological agents, and cell- and gene-based therapies for testing in clinical trials. It is equipped with four Grade B and C cleanrooms that are used to process and manufacture these products. Having immediate access to this strictly controlled environment ensures that quality is built into each step of the design and manufacturing process. For example, the cleanrooms have very low levels of environmental contaminants like lint, dust, aerosol particles and airborne microbes. Moreover, the volume of air in each cleanroom is exchanged more than 260 times per hour. This guarantees that products developed in the lab are safe, pure and effective for clinical evaluation.

This lab will help move preclinical findings—such as the landmark discovery by Dr. Juan Carlos Zúñiga-Pflücker of how to generate stem cells in the lab, and coax them into becoming mature T cells, toward rebuilding damaged immune systems—faster and more efficiently to the clinic. Current projects include isolating and culturing islet cells from the pancreas to treat diabetes; aseptic expansion of T cells; and viral transduction of T cells for treating a genetic disorder. Dr. Charles Cunningham, a senior scientist in Physical Sciences, is producing an MRI contrast agent to detect early-stage heart failure using a novel imaging technique. He is also studying whether this agent can show if metastatic cancers are responding to therapy.

Sunnybrook Research Institute (SRI) is at the forefront of inventing methods and technologies to generate new cell types from stem cells or other stem-cell-like cells, and to re-educate cells. For example, Dr. Marc Jeschke, a senior scientist in Biological Sciences, will use the good manufacturing practices facility to prepare isolated autologous stem cells to treat burn patients.

The facility is essential to the translational research process. It is a resource for all scientists at SRI and is available to external researchers, too.