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Recent advances in cell biology and genetic engineering have changed the way we think about medicine.
Indeed, we are witnessing a potential shift from the traditional paradigm of health care to one with greater focus on the possibility of regenerative and curative treatments.
For other therapies and RM applications, decentralized manufacturing may be more appropriate, although few models have been developed and implemented to date. For translation into successful industry and clinical products, cell therapies must ensure that such CQA-driven quality manufacturing processes are in place, and that those processes are robust, reproducible, and cost effective.
Ultimately, issues of cell sourcing, raw material, and product quality control, automation, and the analytical footprint needed for robust and reproducible manufacturing will determine the appropriate model (see Source: Haddock, R., S. In addition to addressing the lack of regulatory standards in the field, there is an ongoing international effort to address standards of development for several aspects of the manufacturing of these novel products, including bioprocessing equipment, ancillary materials, cell counting, and transportation and logistics within International Organization for Standardization (ISO) initiatives, to name a few.
It departs from an understanding that while there are currently an increasing number of products in the clinical pipeline and on the market, the industry has yet to coalesce around an appropriate cell sourcing, manufacturing, and logistics and delivery model, in part due to the rapid speed at which this sector evolves. Products that are not unique to the patient (e.g., allogeneic cell therapies, universal tissues) and have adequate stability to be shipped globally could be supplied via a single central manufacturing site, thus providing efficiency and consistency.
Some of this increase in health care costs will accrue because of palliative treatment of chronic diseases like heart disease, cancer, stroke, diabetes, and osteoporosis .
The focus of the June 2017 workshop will be on manufacturing challenges associated with novel RM products. A distributed model requires special consideration for consistency of manufacturing and analytical methods across sites and centralized oversight for data trending and release.