As this special Pall supplement of BioProcess International issue goes to press, progress continues in the field of cell therapy research. The revival of cell (and gene) therapy has been driven by some positive achievements that have occurred over the past decade. Cell therapy products differ in many ways from traditional small-molecular and biologic products. The main difference is that, contrary to traditional biopharmaceutical applications in which cells secrete the product of interest, in cell therapy applications cells are the…

Cell-based products are becoming increasingly important as potential biotherapies. Cell therapy is predicted to have a huge impact on the healthcare sector over the coming decades. Stem cells, in particular, are investigated as potential treatments for a diverse range of applications (such as heart disease and metabolic and inflammatory disorders) in which they might be used to restore lost biological functions. Read the full text of this article in the PDF (Login required).

Mesenchymal stem cells (MSCs) are self-renewing cells that differentiate into several terminally differentiated cell types. These cells have been isolated from multiple sources such as bone marrow, adipose tissue, peripheral blood, and other adult tissues(1–6). The interest in these cells is that they hold the potential to cure disease and are being pursued in clinical trials. Three emerging fields of interest for stem cells are cell therapy, regenerative medicine and screening of candidate drugs. In many cases, poor correlation between…

Rapid progress is occurring in the field of stem cell therapy research, and increasing numbers of products will begin reaching the market in the near future. But new cell therapy treatments must fit into a competitive and highly regulated healthcare environment. Succeeding in that environment requires alignment between a company’s business model and its manufacturing strategy. Read the full text of this article in the PDF (Login required).

In the past few years, the resurgence of cell-based immunotherapies — and, by extension, gene therapies — has accelerated as products move rapidly from academic research laboratories into commercial development. A successful clinical trial by St. Jude Children’s Research and the University College London of a gene therapy for hemophilia B was a seminal translational event (1), as was the licensing of the University of Pennsylvania’s gene-modified chimeric antigen receptor T-cell technology (CAR-T) for leukemia by Novartis (2). CAR-T cells…

Cell-based therapies hold promise for treating many acute and chronic diseases (1). Optimism surrounding that therapeutic potential has driven the initiation of multiple clinical trials in pursuit of such treatments. Procedures for preparing these therapeutic agents begin with selective isolation of cells from desired tissues. That is followed by ex vivo expansion of cells of desired phenotype and functionality. Once expanded to acceptable levels, cells are stored to preserve their viability during transportation to treatment facilities. The final step in…