Our Manufacturing Process

Osiris Therapeutics, Inc. adheres to strict FDA regulations in the production and formulation of our stem cell treatments to ensure that our products are of the highest quality and safety.

Osiris Therapeutics has developed a first-in-field manufacturing process for the expansion of human mesenchymal stem cells (MSCs). This "universal" strategy significantly reduces the cost per treatment. 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 better support ongoing and projected clinical trials.

Human MSCs are derived from bone marrow aspirate obtained from qualified donors. Prior to donation, these individuals undergo a battery of tests to ensure that they are free from such diseases as HIV and hepatitis. Since the MSC is extremely rare, accounting for only 1 cell in every 100,000 cells in bone marrow, an initial purification process is required. Upon arrival at Osiris, the MSCs are isolated and selectively removed from the bone marrow aspirate. These cells are then expanded, harvested, packaged and cryopreserved as an in-process intermediate, where a second series of tests ensure the highest level of quality and safety. Each packaged intermediate undergoes an additional round of expansion to produce the final product. Sterility and quality testing complete the process. Osiris has worked with qualified vendors to develop a supply chain with established material specifications that supports the manufacturing process. All manufacturing activities are performed in compliance with the Food and Drug Administration's current Good Manufacturing Practices (cGMP) standards.