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…

With numerous cellular and gene therapy products seeing strong initial clinical successes, investment in next-generation technologies by both large bio/pharma companies and start-up specialist firms has been significant. In fact more than 750 companies worldwide declare themselves to be in the “regenerative medicine” market space, with a high percentage of year on year increases in the number of cellular and gene therapy drugs in clinical trials. Many of these companies are eager to advance from early stage clinical trials to…

For years, availability has cornered cell therapy manufacturers into utilizing transfer sets intended for other industries and applications. These transfer sets or accessory sets are not designed for cell therapy, and therefore lack key requirements, essential to clinical and commercial manufacturing. Many current personalized cell therapies are highly manual in practice, and require numerous ancillary components and handling steps. Modifications to these processes further complicate this inherently challenging process. These deviations impact the reproducibility of the manufacturing platform, as well…

Cell therapies offer new opportunities for the treatment of disease and injury but considerable infrastructure and a complex range of activities and expertise are required to translate a promising cell therapy product into clinical use. Suppliers, developers, regulators, and care givers need to interact cooperatively in order to bring therapies to patients in the most efficient, safe, and economically viable way and GE Healthcare is working with the Karolinska University Hospital to investigate more effective routes for bringing potential cell…