Advances in cell biology and genetic engineering have changed the way we think about medicine. Regenerative medicine will soon be the standard of care for replacing/repairing tissue/organ systems according to the United States Department of Health and Human Services Report, “2020: A New Vision—A Future for Regenerative Medicine.” Today, regenerative medicine therapies include a broad array of stem-cell therapies, immunotherapies, engineered tissues, organs, gene therapies, cell-based devices, cell-free implants, and biomaterials that aid in-situ tissue regeneration. Along with an increasing number of products in the clinical and commercial pipeline, there exists a timeline compression between therapy discovery to clinical implementation. This gives rise to multiple challenges associated with manufacturing, storage, and distribution, all of which need to be addressed in order to assure the development of safe, efficacious, and cost-effective therapies.
The goal of this research topic is to (i) shed light on the current methods used for manufacturing, storage, and transport of regenerative therapies, (ii) encourage the implementation of quality by design (QbD) as a backbone to therapy development to ensure the highest quality and reproducibility of manufacturing processes, and (iii) to unravel the challenges in the consistent manufacture, storage, transport and implementation of therapies across geographical boundaries with the current model of centralized manufacturing. This issue is intended at bringing together scientists working on fundamental research, entrepreneurs, clinicians, and regulatory bodies that are working at the core of each of these processes within a single platform, encouraging the free flow of information and thereby advancement of the regenerative medicine sector. Original research, reviews, perspectives, and opinions summarizing the current state and future directions of the field are particularly welcome.
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