Even though there has been an increasing number of cell therapies advancing to late-stage clinical development, several aspects of cell therapy development continue to present considerable challenges for large scale commercialization. It is clear that production of biologics in general carries higher risks than of small molecules pharmaceuticals and this becomes even more evident as production of cell therapies ramps up to meet broader demand.
One of the main struggles by companies working in the space is in identifying the optimal strategy to transition into commercialization without compromising the quality of product, which is the reason why most biotechs fail in complying with FDA regulations.
The development of new technologies and approaches, like semi or fully automated systems and disposable/single-use technologies can be the key to address and overcome most of the manufacturing challenges faced by the industry, but they are still far from being absolutely reliable, as their results are being observed in a case-by case basis. Companies like Organogenesis and Aastrom have been deploying promising strategies to overcoming these issues.
At this year's Stem Cells USA & Regenerative Medicine Congress, these manufacturing challenges will be at the center of the discussions about the future of the stem cells, cell and gene therapies industry.
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