Our Manufacturing Process
Osiris Therapeutics has developed a first-in-field manufacturing process for the expansion of human mesenchymal stem cells (MSCs). In 1998, Osiris' first product candidate was manufactured and released for use in a clinical trial setting. Since that time, we have continually improved the manufacturing process to support ongoing development and clinical trials.
The foundation of the ability to manufacture human mesenchymal stem cells (MSCs) at large, commercial scale and distribute them for widespread clinical use is the immuno-privileged characteristics of the cell that permit them to be used allogeneically without typing or matching. Since the MSC is extremely rare, accounting for only one cell in every 100,000 cells in bone marrow, an initial purification process is required for successful manufacture, and the subsequent cell expansion process allows for a large, homogeneous population of cells to be produced.
The manufacturing process for ex-vivo cultured adult hMSCs has been designed and implemented in a manner consistent with International Conference on Harmonization (ICH) and Food and Drug Administration (FDA)’s guidelines. All manufacturing activities are performed in compliance with the Food and Drug Administration's Current Good Manufacturing Practices (cGMP) standards. Manufacturing procedures also passed review by European regulatory agencies before conduct of phase III clinical testing in that region.
In Osiris’ manufacturing process, human MSCs are derived from bone marrow aspirate obtained from qualified healthy adult donors. Prior to donation, these individuals undergo extensive screening and testing using validated, approved tests for diseases like HIV and hepatitis. The ex-vivo cultured adult hMSC process consists of two steps. The first step is the initial isolation of the MSCs from the bone marrow aspirate and production of an in-process intermediate that provides a stopping point in the manufacture and permits initial Quality Control testing to occur. This testing reduces risk by testing the potential and safety of the donor before further manufacturing. The in-process intermediate then undergoes final manufacturing to yield final product, which must pass stringent criteria before release and distribution.