The rapidly developing global cell therapy market poses numerous industry challenges for drug development, process scalability, commercialization, and patient safety. The processes of procuring human tissue for clinical applications are fraught with many technical, ethical, and legal issues. Allogeneic cell therapies involving primary cell types such as bone marrow mesenchymal stromal/stem cells (BM-MSCs), hematopoietic stem and progenitor cells (HSPCs), and T and NK cells for immunotherapy applications are especially challenging due to the vigorous process of screening and qualifying human…

Over the past decade, stem cell research has provided new avenues for deeper investigation into tissue repair and aging processes, as well as regenerative medicine methods. One of the major players in such research endeavors are mesenchymal stem cells (MSC), also known as mesenchymal stromal cells. MSC are typically found in bone marrow, adipose, placental, and umbilical cord tissues1 and are a type of adult stem cell. In vivo, these cells are headquartered in special microenvironments or “niches” in the…

It’s time to tackle the challenges of sustainable and cost-effective commercial manufacturing regarding cell and gene therapy. Cell and gene therapies have many of the same manufacturing needs as biopharmaceuticals. As a result, industry experts expect single-use technologies used in biopharmaceutical clinical trials and commercial production to play a larger role in the future development and production of cell and gene therapy. Single-use systems are already incorporated in the development of cell and gene therapies today. However, many of those…