CELL THERAPIES - The Challenges & Possible Solutions for Transferring Cell Therapy From the Bench to the Industry | Articles | Back Issues | Drug Development & Delivery

In the past decade, it has been proven that cell therapy works in the lab, in preclinical settings, and in small-scale clinical trials. The need for large quantities of cells with high quality becomes crucial as product candidates advance into clinical trials and early commercial products. Throughout recent years, many companies had invested efforts in developing culturing technologies that will allow large-scale culturing and manufacturing of cells. These technologies are evolving from tissue culture dishes and flasks to high-end, fully controlled bioreactor systems, which will allow production of large quantities of cells under cGMP (Current Good Manufacturing Procedures). The challenge becomes even bigger when looking at “off-the-shelf” allogeneic therapy. When mature, the industry will face an even larger challenge of downstream processing of the cell products. The following will discuss the significant emerging challenges in downstream processing of cell therapies focused mostly on allogeneic therapies.