CGMP Production of MSCs

Abstract

Over the past decade, mesenchymal stromal/stem cells (MSCs) have evolved into an important cell therapy demonstrating potential utility in a range of clinical applications, including bone and cartilage repair, cardiac repair, and immune disorders. MSCs can be isolated from a variety of tissue sources, including bone marrow, adipose tissue, dental pulp, and placenta. Groups have developed different manufacturing processes with a goal of improving the quality of clinical-grade cells and the overall efficiency of the manufacturing process. Variations in cell source and manufacturing process may have a significant impact on the efficacy of the final MSC product. Moreover, this variability in cell source and manufacturing processes has made it challenging to compare the resulting MSC products and associated results from clinical trials that have been conducted to date. The development of consistent, well-controlled manufacturing processes along with the implementation of thorough quality control testing, including rigorous potency assays, will insure high quality and may help to clarify the impact of cell source and manufacturing process on the resulting MSC product. In addition to providing an overview of the current good manufacturing practice (cGMP) methods for MSC production, this chapter summarizes key FDA regulatory requirements, including those related to cell source, raw materials, and quality control testing.