Articles
Current And Future Frameworks For Cell- And Tissue-Based Products
March 4, 2009
•Article: Current And Future Frameworks For Cell- And Tissue-Based Products
By Isabelle Mingam and Anne Dupraz-Poiseau
Gene, cell, and tissue-based therapies share several characteristics linked to their intrinsic innovative properties. They are manufactured through complex processes, they raise major public health concerns because they involve manipulation of human genes and cells, and they require stringent long-term traceability. Interest in these products is rapidly growing because such innovative therapies constitute a promise of treatment for diseases that have been difficult to treat or cure. Emergent therapies regrouped under the term advanced therapy products (ATP) have posed a conundrum for regulators in the past few years. Here we aim to clarify available and potential regulatory pathways for celland tissue-based products and identify some strategies that developers can use to maintain a competitive position in the marketplace.
Reprinted with permission from BioProcess International 4(5):12-17 (May 2006)
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